18 results
Page of 2
  • A Dose Finding Study of CycloSam? (153Sm-DOTMP) to Treat Solid Tumor(s) in the Bone or Metastatic to the Bone (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewings Sarcoma, and other solid tumor(s) to the bone all eligible).

    The primary objective of this study is: To determine the MTD of CycloSam?, given as a tandemly administered pair of doses to subjects with one or more solid tumor(s) in the bone or metastatic solid tumors to the bone that are visible on bone scan. The secondary objectives of this study are: 1. To describe the toxicity and long-term effects of infusional CycloSam?; 2. To assess the clinical response of solid tumors to the bone or metastatic to the bone to therapy with infusional CylcoSam?; 3. To describe the distribution of absorbed doses delivered to each targeted lesion and the distribution of lesion equivalent uniform dose delivered to each subject; 4. To observe overall survival and time to progression in subjects treated with infusional CycloSam?, and model any relationship between total absorbed dose and progression; 5. To assess the extent of pain palliation using a visual analogue scale (VAS) in subjects treated with infusional CycloSam?.

    View All Details
    • Protocol Number:
      052201

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Breast,Prostate,Lung,Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      CycloSam (153Sm-DOTMP)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel
    • Rutgers Cancer Institute of New Jersey
  • A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer (ECLIPSE). - NCT05204927

    Primary Objective: To prospectively assess the efficacy of 177Lu-PSMA-I&T on the improvement of radiographic progression-free survival (rPFS) as determined by PCWG3-modified RECIST 1.1 in men with metastatic Castration-Resistant Prostate Cancer (mCRPC) compared to standard of care hormone therapy. Secondary Objectives: To assess if 177Lu-PSMA-I&T improves overall survival (OS) in patients with mCRPC compared to those treated with standard of care hormone therapy. Other Secondary Objectives: 1. To assess the time to the second radiographic progression event in participants who crossover from standard of care hormone therapy to treatment with 177Lu-PSMA-I&T (rPFS2). 2. To assess the time to progression as determined by the investigator in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy. 3. To assess the time to progression 2 as determined by the investigator in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy. 4. To evaluate the change in baseline PSA50 response rate following 177Lu-PSMA-I&T radioligand therapy compared to standard of care hormone therapy. 5. To assess the time to first symptomatic skeletal event (SSE) following treatment with 177Lu-PSMA-I&T radioligand therapy compared to standard of care hormone therapy. 6. To evaluate the time to radiographic soft tissue progression in participants treated with 177Lu-PSMA-I&T compared to those treated with standard of care hormone therapy. 7. To evaluate the time to chemotherapy in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy. 8. To assess any improvement in the quality of life measurements in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy.

    View All Details
    • Protocol Number:
      082107

    • Principal Investigator:
      Tina Mayer M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Prostate

    • Therapies Involved:
      Hormonal Therapy

    • Drugs Involved:
      177Lu-PSMA-I&T Abiraterone

      • Contacts:

      • Rutgers University Prinicipal Investigator: Tina Mayer M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male 18 years or older able to understand and provide signed written informed consent. 2. Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component. 3. Progressive disease by one or more of the following criteria: 1. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart with a minimum start value of >2 ng/mL. 2. Progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria). 4. Previous treatment with next-generation androgen receptor (AR)-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide). 1. Must have received no more than one previous AR-directed therapy. 2. Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castration-resistant setting. 3. Must have progressed while on ARAT. 5. PSMA-PET scan (e.g., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by central reader. 6. Effective castration with serum testosterone level of <50 ng/dL and plan to continue with chronic medical or surgical castration. 7. Ability to attend required study visits and return for adequate follow-up, as required by this protocol. 8. Patients with HIV that are healthy and with a low risk of acquired immune deficiency syndrome related outcomes may participate in the trial at the investigators' discretion. 9. Patients with HBV and HCV may also participate if symptoms are sufficiently managed. 10. Life expectancy of at least 6 months as assessed by investigator. 11. Willing to initiate ARAT therapy determined by investigator. 12. For patients who have partners of childbearing potential: The patient and/or partner must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 6 months after the last study drug administration.

    Exclusion Criteria:

      1. Prior treatment with radioligand therapy including other lutetium-labeled compounds. 2. Prior treatment with radium-223 (Xofigo) within the past 12 weeks. 3. Prior chemotherapy treatment for castration-resistant prostate cancer. Prior docetaxel use in the hormone-sensitive setting is permitted, as long as no more than 6 doses were received, the last dose was administered >1 year prior to consent, and disease progression did not occur during docetaxel treatment. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2 5. Patients with known HRR gene-mutation who have not been previously treated with olaparib or rucaparib. 6. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. 7. Inadequate organ and bone marrow function as evidenced by: 1. Hemoglobin < 8 g/dL. 2. Absolute neutrophil count < 1.5 x 109/L. 3. Platelet count < 100 x 109/L. 4. AST/SGOT and/or ALT/SGPT > 3.0 x ULN. 5. Total bilirubin > 2 x ULN unless patient has known Gilbert's syndrome and then may be 3 x ULN. 6. Creatinine clearance (CrCl) < 50 mL/min based on the Cockcroft-Gault equation. 7. Albumin ≤ 2.75 g/dL 8. Patients who undergo a transfusion for the sole purpose of meeting eligibility for this trial will be excluded. 9. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol. 10. Use of an investigational therapeutic drug within the last 4 weeks prior to start of study treatment or scheduled to receive one during the study period. 11. Known CNS metastasis unless received therapy, asymptomatic and neurologically stable. 12. Patients receiving zoledronic acid for bone-targeted therapy must be on stable dose for 4 weeks prior to randomization. 13. Major surgery within 30 days of randomization as determined by the Investigator. 14. Patients with active significant cardiac disease defined by any of the following: 1. New York Heart Association class 3 or 4 congestive heart failure within 6 months of signing the ICF unless treated with improvement. 2. Current diagnosis of electrocardiogram abnormalities with significant cardiac arrhythmias 3. History of long QT syndrome or know history of Torsades de Pointe 4. History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months of ICF signature 15. Participants with symptomatic cord compression or clinical/radiological findings indicating impending spinal cord compression 16. Patients with a superscan seen on baseline bone scan as determined by investigator. 17. Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer 18. Previous use of G-CSF for persistent neutropenia after standard of care treatment. 19. Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy. 20. Participants with active Covid19. Recovered patients may be included when completely recovered (no symptoms at least 28 days before study medication and a negative Covid test within 72 hours).

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 1/2 Study of Combination Olaparib and Radium-223 in Men with Metastatic Castration-Resistant Prostate Cancer with Bone Metastases (COMRADE). - NCT03317392

    Primary Objectives: (1) Phase 1: Determine the maximum tolerated dose (MTD) of olaparib in combination with radium-223. (2) Phase 2: Evaluate the radiographic progression-free survival (rPFS). Secondary Objectives: (1) Evaluate safety and tolerability as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. (2) To evaluate rPFS as stratified by disease extent (≤20 or > 20 bone lesions) and prior docetaxel use (yes or no). (3) Evaluate rPFS in patients harboring or lacking evidence of homologous recombination deficiency (HRD). HRD will be defined by the presence of homozygous deletion AND/OR putative deleterious mutation in a gene reported to be involved in homologous recombination DNA repair as determined by next generation sequencing. (4) Evaluate rPFS in patients based on prior abiraterone and/or enzalutamide use (yes versus no). (5) Evaluate prostate specific antigen (PSA) response rate as defined by ≥50% decline in PSA from baseline. (6) Evaluate total alkaline phosphatase response defined as a reduction of 30% from the baseline value, confirmed; 4 weeks later. (7) Evaluate time to PSA progression as defined by Prostate Cancer Clinical Trials Working Group (PCTWG) 3 criteria. (8) Evaluate radiographic objective response rate as defined by Response Evaluation Criteria In Solid Tumor (RECIST) version 1.1. (9) Evaluate time to increase in the total alkaline phosphatase (ALP) level defined as an increase of 25% from baseline;12 weeks, in patients with no decrease from baseline, or as an increase of 25% above the nadir, confirmed 3 weeks later, in patients with an initial decrease from baseline. (10) Evaluate time to first subsequent anti-cancer therapy (including androgen receptor (AR) signaling agents, cytotoxic chemotherapy, immunotherapy, or investigational agents) or death. (11) Evaluate time to first symptomatic skeletal event (SSE). (12) Evaluate overall survival (OS).

    View All Details
    • Protocol Number:
      081908

    • Principal Investigator:
      Biren Saraiya M.D

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Prostate

    • Therapies Involved:
      Radiotherapy Chemotherapy (NOS)

    • Drugs Involved:
      Olaparib

      • Contacts:

      • Rutgers University Prinicipal Investigator: Biren Saraiya M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate
    • Participants must have castrate levels of serum testosterone < 50 ng/dL
    • Participants without orchiectomy must be maintained on luteinizing hormone releasing hormone (LHRH) agonist/antagonist; participants receiving prior docetaxel abiraterone, or next generation AR antagonist (enzalutamide, apalutamide, or darolutamide) for hormone sensitive disease are permitted
    • Participants must have progressive disease as defined by any of the following:
    • Castrate resistant disease as defined by PCWG-3 criteria; participants must have a rise in PSA on two successive determination at least one week apart and PSA levels >= 2 ng/mL (only the screening PS needs to be >= 2 ng/mL) and serum testosterone < 50 ng/dL
    • Soft tissue progression as defined by RECIST version 1.1
    • Bone disease progression as defined by PCWG-3 criteria including the development of two or more new lesions on bone scan
    • Participants must have >= 2 bone metastases by radiographic imaging and at least 1 lesion which has not been treated with prior radiation therapy
    • Participants must have tumor accessible for biopsy and be agreeable to baseline tumor biopsy; a metastatic focus is preferred but if not available and prostate is still intact prostate biopsy can be performed
    • Availability at the study site of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens, when available
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)
    • White blood cell count (WBC) >= 3,000/mcL (within 28 days prior to administration of study treatment)
    • Absolute neutrophil count (ANC) >= 1,500/mcL (within 28 days prior to administration of study treatment)
    • Platelets >= 100,000/mcL (within 28 days prior to administration of study treatment)
    • Hemoglobin >= 10 g/dL (transfusions permitted) (within 28 days prior to administration of study treatment)
    • Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment); for subjects with Gilbert's disease =< 3.0 mg/dL
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to administration of study treatment)
    • Creatinine clearance >= 51 ml/min as defined by Cockcroft-Gault equation (within 28 days prior to administration of study treatment)
    • Participants should be receiving an osteoclast targeting agent including either bisphosphonates or denosumab except in patients with contraindications as determined by the treating investigator including:
    • Hypocalcemia
    • Hypophosphatemia
    • Renal impairment including those with a glomerular filtration rate < 35 mL/min using the Cockcroft-Gault equation
    • Hypersensitivity to drug formulation
    • Dental condition or need for dental intervention that per the investigator would increase the risk of osteonecrosis of the jaw
    • The effects of olaparib and radium-223 on the developing human fetus are unknown; for this reason, men treated or enrolled on this protocol must agree to use adequate contraception and avoid sperm donation prior to the study, for the duration of study participation, and three months after discontinuation of olaparib and radium-223 administration
    • Human immunodeficiency virus (HIV)-positive with negative viral loads on stable antiretroviral regimen and CD4 count > 250 are eligible
    • Ability to understand and the willingness to sign a written informed consent document; patients with impaired decision-making who have a legal guardian (e.g., spouse) able to make informed decisions on behalf of the patient are eligible
    • Patients must be able to tolerate oral medications by mouth and not have a gastrointestinal illness that would preclude absorption of olaparib

    Exclusion Criteria:

    • Pathology consistent with small cell carcinoma of the prostate
    • Presence of visceral metastases (liver, lung, brain, etc.) or malignant lymphadenopathy exceeding 4 centimeters (cm) in short diameter
    • Prior treatment with radium-223
    • Prior treatment with olaparib or other PARPi
    • Treatment with abiraterone, apalutamide, or darolutamide within 2 weeks of treatment initiation; treatment with cytotoxic chemotherapy within 3 weeks of treatment initiation; treatment with investigational prostate cancer directed therapy within 4 weeks of treatment initiation; treatment with enzalutamide within 4 weeks of treatment initiation
    • Prior hemibody external radiotherapy
    • Palliative radiation therapy to the bone or other sites within 2 weeks of treatment initiation
    • Participants who are receiving any other investigational agents
    • Imminent or established spinal cord compression based on clinical and/or imaging findings
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring need for intravenous anti-microbials, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    • Clinically significant medical condition defined as:
    • Cerebral infarction within 6 months of study treatment
    • Transient ischemic attack within 3 months of study treatment
    • Myocardial infarction within 6 months of study treatment
    • Uncontrolled angina within 3 months of study treatment
    • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a screening echocardiogram or multi-gated acquisition scan performed within 3 months of the screening visit results in a left ventricular ejection fraction that is >= 45%
    • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes)
    • Prolonged corrected QT interval by the Fridericia correction formula on the screening electrocardiogram (ECG) > 470 msec (as determined on 2 or more time points within a 24 hour period if the first ECG demonstrates a prolonged corrected QT interval) or family history of long QT syndrome
    • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
    • Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit
    • History of hypertensive emergency or encephalopathy within 6 months of study treatment
    • Deep venous thrombosis or pulmonary embolism within 3 months of study treatment
    • Major surgery within 4 weeks of study treatment; subjects with clinically relevant ongoing complications from prior surgery are not eligible
    • History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
    • Patient unable to swallow orally administered medication
    • History of bowel obstruction within 1 month of study treatment
    • History of abdominal fistula, intra-abdominal abscess, or gastrointestinal perforation within the 3 months of study treatment
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib or radium-223
    • Participants receiving strong CYP3A4/5 inducers or inhibitors are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension; the required washout period prior to starting olaparib is 2 weeks for CYP3A inhibitors; the required washout period prior to starting olaparib is 4 weeks for enzalutamide or phenobarbital and 3 weeks for other CYP3A inducers
    • Patients with known active hepatitis (i.e. hepatitis B or C) infection
    • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML
    • Patient having received prior allogenic bone marrow transplant or double umbilical cord blood transplantation
    • Individuals with a history of a different malignancy are ineligible except for the following circumstances:
    • Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, or
    • Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: superficial bladder cancer, basal cell or squamous cell carcinoma of the skin

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants with Metastatic Castration-Resistant Prostate Cancer - NCT05553639

    Phase 1 Study Objectives: Primary To determine the RP2D in terms of safety and tolerability for: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC To assess the safety and tolerability of: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC Secondary To assess the preliminary antitumor activity of: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC Exploratory To characterize the preliminary immunogenic properties of: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC To determine the biomarkers correlating with immune response and/or antitumor response to: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC To determine the changes in metabolic activity of tumor FDG-PET following at least 1 dose of: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC Phase 2 Study Objectives Primary To assess the preliminary antitumor activity of: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC Secondary To confirm duration of preliminary antitumor activity of: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC To assess the safety and tolerability of: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC Exploratory To characterize the preliminary immunogenic properties of: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC To determine the biomarkers correlating with immune response and/or antitumor response to: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC To determine the changes in metabolic activity of tumor by FDG-PET following at least 1 dose of: HB-302/HB-301 alternating 2-vector therapy in participants with mCRPC

    View All Details
    • Protocol Number:
      082211

    • Principal Investigator:
      Biren Saraiya M.D

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Prostate

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      HB-301 HB-302

      • Contacts:

      • Rutgers University Prinicipal Investigator: Biren Saraiya M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male participants ≥18 years of age on day of signing the informed consent form (ICF) 2. Confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, and evidence of metastatic disease. 3. Documented castration-resistant disease with serum level of testosterone <50 ng/dL (1.7 nmol/L). 4. Have been treated with at least one second-generation androgen receptor signaling inhibitor (ARSI) (e.g., enzalutamide)
    • No prior chemotherapy regimens are permitted (docetaxel in the castration-sensitive setting is acceptable)
    • Participants must have had disease progression on SOC therapy assessed by the Investigator.
    • Antiandrogen/ARSI withdrawal must take place at least 2 weeks before enrollment unless agreed otherwise between the Sponsor and the Investigator. LHRH agonists or antagonists should be continued. 5. Must have ≥1 metastatic lesion that is present on baseline imaging
    • Participants with liver metastasis are not eligible to enroll in this study
    • Participants with only bone metastasis present at baseline are eligible to enroll in this study 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1. 7. Prior curative radiation therapy must have been completed at least 4 weeks prior to study drug administration. Prior focal palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration. 8. Screening laboratory values must meet the criteria for adequate organ function that will be decided by the investigator.

    Exclusion Criteria:

      1. Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive study treatment, or interfere with the interpretation of the study results. This includes clinically significant (i.e., active) cardiovascular disease, including cerebral vascular accident/stroke and myocardial infarction less than 6 months prior to enrollment, unstable angina, congestive heart failure (New York Heart Association Classification Class II), or serious uncontrolled cardiac arrhythmias (including prolonged corrected QT interval, uncontrolled atrial fibrillation, etc.) 2. Uncontrolled pain or uncontrolled symptoms related to worsening of underlying disease or symptomatic bone metastasis. 3. An active autoimmune disease that has required systemic treatment in past 2 years. • Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. 4. Has received the following immunosuppressive or systemic replacement medication:
    • Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses >10 mg/day prednisone or equivalent), within 14 days of the first administration of study treatment. • Note: inhaled or topical steroids and adrenal replacement in doses equivalent to >10 mg/day prednisone are permitted in the absence of active autoimmune disease.
    • Any chronic immunosuppressive medication within 6 months prior to the first administration of study treatment (unless agreed otherwise between the Sponsor and the Investigator on a case-by-case basis). 5. Has received a live or live-attenuated vaccine within 30 days of planned start of study therapy, unless agreed otherwise between the Sponsor and Investigator. • Administration of non-live vaccines is allowed. 6. Currently participating in or has participated in a study of an investigational agent or has used an investigational device treatment, within 4 weeks prior to the first dose of treatment. 7. Allogeneic tissue/solid organ transplant (e.g., allogeneic stem cell transplantation, xenogeneic transplant). 8. Active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or epidural or neurological metastasis. 9. Active infection requiring systemic therapy. 10. Positive COVID-19 test in 6 weeks prior to the enrollment. 11. Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 12. Known history of Hepatitis B (HBV) (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C (HCV) infection (defined as HCV ribonucleic acid [RNA] is detected [qualitative]). 13. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors. - NCT03067181

    The aim of this study for low and standard risk germ cell tumor (GCT) patients is to minimize toxicity by reducing therapy while maintaining current survival rates. The trial will eliminate chemotherapy for low risk patients who are likely cured with surgery and will observe the salvage rates among those who recur.

    View All Details
    • Protocol Number:
      111702

    • Principal Investigator:
      Archana Sharma DO

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site,Ovary,Prostate

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      ETOPOSIDE CARBOPLATIN BLEOMYCIN CISPLATIN

      • Contacts:

      • Rutgers University Prinicipal Investigator: Archana Sharma DO

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])
    • Standard risk 1: Patient must be < 11 years of age at enrollment
    • Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
    • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment
    • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages
    • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
    • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
    • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11
    • Standard risk 2 (SR2)
    • Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25
    • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
    • Notes:
    • IGCCC criteria only apply to SR2 patients with a testicular primary tumor
    • Use post-op tumor marker levels to determine IGCCC risk group
    • Stage 1 seminoma patients are not eligible for the standard risk arms of the study
    • For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
    • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
    • Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
    • Adequate renal function defined as:
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to enrollment) OR
    • A serum creatinine based on age/gender as follows (within 7 days prior to enrollment): (mg/dL)
    • 1 month to < 6 months male: 0.4 female: 0.4
    • 6 months to < 1 year male: 0.5 female: 0.5
    • 1 to < 2 years male: 0.6 female: 0.6
    • 2 to < 6 years male: 0.8 female: 0.8
    • 6 to < 10 years male: 1 female: 1
    • 10 to < 13 years male: 1.2 female: 1.2
    • 13 to < 16 years: male: 1.5 female: 1.4
    • >= 16 years male: 1.7 female: 1.4
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
    • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L) (within 7 days prior to enrollment)
    • Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 (within 7 days prior to enrollment) AND
    • Platelet count >= 100,000/mm^3 (within 7 days prior to enrollment)
    • Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
    • Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
    • >= 11 and < 25 years old at enrollment
    • Able to fluently speak and read English
    • Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
    • Followed for cancer or survivorship care at one of the following institutions:
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    • Dana Farber/Harvard Cancer Center
    • Hospital for Sick Children
    • Children's Hospital of Eastern Ontario
    • Oregon Health and Science University
    • Seattle Children's Hospital
    • Yale University

    Exclusion Criteria:

    • Patients with any diagnoses not listed including:
    • Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
    • Pure dysgerminoma
    • Pure mature teratoma
    • Pure immature teratoma COG stage I, grade I
    • Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) >= 1000 ng/mL
    • Pure immature teratoma COG stage II - IV or FIGO stage IC to IV
    • "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or
    • Primary central nervous system (CNS) germ cell tumor
    • Germ cell tumor with somatic malignant transformation
    • Spermatocytic seminoma
    • Patients must have had no prior systemic therapy for the current cancer diagnosis
    • Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)
    • Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
    • Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase II Randomized Pilot Study Comparing High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy in Localized Prostate Cancer. - NCT04253483

    AIM 1: To assess differences in HRQoL in the acute and long-term setting using the Expanded Prostate Index Composite (EPIC)-26 short form. Patient-reported HRQoL scores in the bowel, sexual and urinary domains will be evaluated at baseline, 1,3,6,9,12,18,24 and 36 months. A 10-point difference between the two treatment modalities will be considered significant. AIM 2: To assess tumor control and determine if the 36-month repeat prostate biopsy is a predictor of biochemical failure. A repeat prostate biopsy at 36 months and serial Prostate-Specific Antigen (PSA) measurements will be performed to assess local tumor control and biochemical failure, respectively. We will evaluate the predictive value of posttreatment prostate biopsy at 36 months with respect to biochemical failure.

    View All Details
    • Protocol Number:
      081805

    • Principal Investigator:
      Lara Hathout MD

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Prostate

    • Therapies Involved:
      Radiotherapy

      • Contacts:

      • Rutgers University Prinicipal Investigator: Lara Hathout MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 9 months)
    • Low-risk and intermediate-risk patients are eligible according to the following guidelines:
    • Low and intermediate-risk disease defined as:
    • Clinical stage T1-T2 and Gleason =< 7 and prostate specific antigen (PSA) < 15 ng/ml
    • Lymph node evaluation by either computed tomography (CT) or magnetic resonance imaging (MRI) and bone scan are optional and are left at the discretion of the treating physician
    • Prostate MRI is recommended by not mandatory
    • No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization
    • Eastern Cooperative Oncology Group status 0-1
    • Judged to be medically fit for brachytherapy by a radiation oncologist
    • Concurrent, neoadjuvant and/or adjuvant androgen deprivation therapy (ADT) is not permitted
    • Prostate volume by trans-rectal ultrasound (TRUS) =< 60 cc
    • International Prognostic Scoring System (IPSS) =< 20 (alpha blockers allowed)
    • Patients must sign a study specific informed consent form prior to study entry
    • Patients must by accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center. Investigators must assure themselves that patients enrolled in this trial will be available for complete documentation of the treatment, adverse events, and follow up
    • Protocol treatment is to begin within 4 weeks of patient randomization

    Exclusion Criteria:

    • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumors curatively treated with no evidence of disease for >= 5 years
    • Prior or current bleeding diathesis
    • Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior transurethral resection of the prostate (TURP), prior cryosurgery of the prostate
    • Stage T3b and evidence of nodal or distant metastatic disease on diagnostic CT, MRI or bone scan
    • Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of prostate cancer
    • Severe, active co-morbidity, defined as follows:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial for fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulations defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immumo-compromised patients
    • Patients with history of inflammatory colitis (including Crohn's disease and ulcerative colitis) or collagen vascular diseases including rheumatoid arthritis and lupus are not eligible
    • Subjects who have a history of significant psychiatric illness
    • Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer - EA8171 - NCT03697148

    Primary Objectives To estimate the diagnostic performance of overall PI-RADS score based on local site imaging review of mpMRI (T2W, DWI and DCE) to detect clinically significant prostate cancer. To develop and evaluate a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of clinically significant prostate cancer. Secondary Objectives To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review. Estimate the diagnostic performance of PI-RADS v2.1 for detecting clinically significant prostate cancer among Black or African Americans participants. Exploratory Objectives All clinical data including MR Images will be banked for future exploratory research aims.

    View All Details
    • Protocol Number:
      082213

    • Principal Investigator:
      Thomas Jang M.D

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Prostate

      • Contacts:

      • Rutgers University Prinicipal Investigator: Thomas Jang M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated

    Exclusion Criteria:

    • Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice)
    • Prior surgical and/or non-surgical treatment for prostate cancer
    • Prior hip replacement or other major pelvic surgery

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*). - NCT04513717

    Primary Objective: De-Intensification Study: 1. To determine whether men with NCCN high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (< 0.85) can be treated with 12 months ADT plus RT instead of 24 months ADT+RT and experience non-inferior metastasis-free survival. Intensification Study: 1. To determine whether men with NCCN high risk prostate cancer who are in the upper 1/3 of Decipher genomic risk (>0.85) or have node-positive disease by conventional imaging (MRI or CT scan) will have a superior metastasis-free survival (MFS) through treatment intensification with apalutamide and abiraterone acetate with prednisone added to the standard of RT plus 24 month ADT. Secondary Objectives for both De-Intensification and Intensification Studies: 1. To compare overall survival (OS) between the standard of care (RT plus 24 months of ADT) and either the de-intensification (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). 2. To compare time to PSA failure or start of salvage treatment between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). 3. To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 24 months of ADT) and either the deintensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). 4. To compare MFS judged based on either standard or molecular imaging between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). 5. To compare prostate cancer-specific mortality between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). 6. To compare testosterone levels at the time of PSA failure and metastases between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). 7. To compare time to testosterone recovery (defined as a T>200) between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). 8. To compare adverse events, both clinician-reported using CTCAE v5.0 and patientreported using PRO-CTCAE items, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone).

    View All Details
    • Protocol Number:
      082101

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Prostate

    • Therapies Involved:
      Hormonal Therapy Radiotherapy

    • Drugs Involved:
      Apalutamide

      • Contacts:

      • New Jersey Medical School Prinicipal Investigator: Malcolm Mattes

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • PRIOR TO STEP 1 REGISTRATION
    • Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration
    • High-risk disease defined as having at least one or more of the following:
    • PSA > 20 ng/mL prior to starting ADT Note: Patients receiving a 5-alpha reductase inhibitor (ex. finasteride) at the time of enrollment are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors and the medication should be discontinued prior to randomization but a washout period is not required.
    • cT3a-T4 by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.])
    • Gleason score of 8-10
    • Node positive by conventional imaging with a short axis of at least 1.0 cm
    • Appropriate stage for study entry based on the following diagnostic workup:
    • History/physical examination within 120 days prior to registration;
    • Bone imaging within 120 days prior to registration;
    • Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or sodium fluoride (NaF) PET within 120 days prior to registration (negative NaF PET/CT or negative Axumin or choline PET or negative fluciclovine, choline or prostate-specific membrane antigen (PSMA) PET within 120 days prior to registration is an acceptable substitute if they have been performed). Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or NaF PET will still be eligible
    • CT or MRI of the pelvis within 120 days prior to registration (negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only
    • Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by ≥10 mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e. N1), but whose nodes do not meet traditional size criteria for positivity (i.e. they measure ≥ 10 mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study
    • Age ≥ 18
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
    • Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
    • Platelet count ≥ -100 x 10^3/uL independent of transfusion and/or growth factors (within 120 days prior to registration)
    • Creatinine clearance (CrCl) ≥ 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)
    • For Black patients whose renal function is not considered adequate by Cockcroft-Gault formula, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) may be used for calculating creatinine clearance for trial eligibility
    • Either a CrCl ≥ 30 ml/min or calculated glomerular filtration rate (GFR) ≥ 30 will make a patient eligible
    • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 120 days prior to registration)
    • Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject is eligible
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (within 120 days prior to registration)
    • Serum albumin ≥ 3.0 g/dL (within 120 days prior to registration)
    • The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count ≥ 200 cells/microliter within 60 days prior to registration. Note: HIV testing is not required for eligibility for this protocol. Of note, for patients with HIV in the intensification trial randomized to apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with apalutamide
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable after or on suppressive therapy within 60 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
    • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the principal investigator
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
    • PRIOR TO STEP 2 RANDOMIZATION
    • Confirmation of Decipher score
    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior. Note: Apalutamide may interfere with HCV drugs. Patients on HCV medications should alert their infectious diseases physician if they get randomized to apalutamide due to the possibility that apalutamide can affect the bioavailability of some HCV medications. HCV viral testing is not required for eligibility for this protocol
    • For patients entering the Intensification Cohort ONLY: Patients must discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to Step 2 randomization

    Exclusion Criteria:

    • PRIOR TO STEP 1 REGISTRATION:
    • Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI)
    • Prior systemic chemotherapy within ≤ 3 years prior to registration; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration
    • Prior radical prostatectomy
    • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
    • Current use of 5-alpha reductase inhibitor. NOTE: If the alpha reductase inhibitor is stopped prior to randomization the patient is eligible
    • History of any of the following:
    • Seizure disorder
    • Current severe or unstable angina
    • New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
    • History of any condition that in the opinion of the investigator, would preclude participation in this study
    • Evidence of any of the following at registration:
    • Active uncontrolled infection requiring IV antibiotics
    • Baseline severe hepatic impairment (Child Pugh Class C)
    • Inability to swallow oral pills
    • Any current condition that in the opinion of the investigator, would preclude participation in this study
    • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone-releasing hormone [LHRH] agonist and oral anti-androgen) is ≤ 60 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT
    • PRIOR TO STEP 2 RANDOMIZATION:
    • Evidence of known gastrointestinal disorder affecting absorption of oral medications at registration
    • For patients entering the Intensification Cohort ONLY: Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] ≥ 160 mmHg or diastolic BP ≥ 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Community Medical Center
    • RWJ University Hospital Hamilton
    • Rutgers Cancer Institute of New Jersey
  • Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE). - NCT05050084

    Primary Objective De-Intensification Study: To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with RT alone instead of 6 months ADT + RT experience non-inferior rate of distant metastasis. Intensification Study: To determine whether men with NCCN UIR prostate cancer who are in the higher genomic risk (Decipher score ≥0.40) will have a superior metastasis-free survival through treatment intensification with darolutamide added to the standard of RT plus 6 months ADT. Secondary Objectives: - To compare overall survival (OS) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. - To compare time to PSA failure between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. - To compare metastasis free survival (MFS) based on conventional imaging between the standard of care (RT plus 6 months of ADT) and de-intensification intervention (RT alone). - To compare MFS based on either conventional and/or molecular imaging between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. - To compare cumulative incidence of locoregional failure based upon conventional imaging and/ or biopsy between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months ADT plus darolutamide) interventions. - To compare cumulative incidence of distant metastasis based upon conventional imaging between standard of care (RT plus 6 months of ADT) and intensification intervention (RT plus 6 months ADT plus darolutamide). - To compare cumulative incidence of distant metastasis based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. - To compare prostate cancer-specific mortality between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. - To compare sexual and hormonal related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. - To compare fatigue, as measured by the PROMIS-Fatigue instrument, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions. - To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.

    View All Details
    • Protocol Number:
      082201

    • Principal Investigator:
      Lara Hathout MD

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Prostate

    • Therapies Involved:
      Radiotherapy Chemotherapy (NOS)

    • Drugs Involved:
      Darolutamide

      • Contacts:

      • Rutgers University Prinicipal Investigator: Lara Hathout MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration
    • Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:
    • Has at least one intermediate risk factor (IRF):
    • PSA 10-20 ng/mL
    • Clinical stage T2b-c (digital rectal examination [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition
    • Gleason score 7 (Gleason 3+4 or 4+3 [ International Society of Urological Pathology (ISUP) Grade Group 2-3])
    • Has ONE or more of the following 'unfavorable' intermediate-risk designators:
    • > 1 immature reticulocyte fraction (IRF)
    • Gleason 4+3=7 (ISUP Grade Group 3)
    • >= 50% of biopsy cores positive
    • Biopsies may include 'sextant' sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such 'sextant' biopsy cores should be counted. Men may also undergo 'targeted' sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s)
    • Absence of high-risk features
    • Appropriate stage for study entry based on the following diagnostic workup:
    • History/physical examination within 120 days prior to registration;
    • Negative bone imaging (M0) within 120 days prior to registration; Note: Tc-99m bone scan or sodium fluoride (NaF) positron emission tomography (PET) are allowed. Equivocal bone scan findings are allowed if plain films X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) are negative for metastasis at the concerned site(s). While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for bone imaging, any suspicious findings must be confirmed and correlated with conventional imaging (Tc-99m bone scan, NaF PET, CT, X-ray, or MRI) to determine eligibility based on the latter modalities (e.g. M0 based on conventional imaging modalities)
    • Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +/- abdominal CT or MR), within 120 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.0 cm in short axis and/or if biopsy is negative. Note: While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for pelvic imaging, any suspicious findings must be confirmed by conventional imaging (CT, MRI or biopsy). If the findings do not meet pathological criteria based on the latter modalities (e.g. node =< 10 mm in short axis, negative biopsy), the patient will still be eligible
    • Age >= 18
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
    • Non-castrate testosterone level (> 50 ng/dL) within 120 days prior to registration
    • Absolute neutrophil >= 1,000 cells/mm^3 (within 120 days prior to registration)
    • Hemoglobin >= 8.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
    • Platelet count >= 100,000 cells/mm^3 independent of transfusion and/or growth factors (within 120 days prior to registration)
    • Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)
    • For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate
    • Total bilirubin: 1.5 =< institutional upper limit of normal (ULN) (within 120 days prior to registration) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin. If direct bilirubin is less than or equal to 1.5 x ULN, subject is eligible)
    • Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]): =< 2.5 x institutional ULN (within 120 days prior to registration)
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; Note: HIV testing is not required for eligibility for this protocol
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
    • Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
    • For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
    • Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

    Exclusion Criteria:

    • Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, high intensity focused ultrasound [HIFU], laser thermal ablation, etc.) for prostate cancer
    • Definitive clinical or radiologic evidence of metastatic disease (M1)
    • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. History of or current diagnosis of hematologic malignancy is not allowed
    • Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields
    • Previous bilateral orchiectomy
    • Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed
    • Prior use of 5-alpha-reductase inhibitors is allowed, however, it must be stopped prior to enrollment on the study with at least a 30 day washout period before baseline study PSA measure and registration
    • Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration
    • Severe, active co-morbidity defined as follows:
    • Current severe or unstable angina;
    • New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
    • History of any condition that in the opinion of the investigator, would preclude participation in this study
    • Inability to swallow oral pills
    • High risk features, which includes any of the following:
    • Gleason 8-10 [ISUP Grade Group 4-5]
    • PSA > 20
    • cT3-4 by digital exam OR gross extra-prostatic extension on imaging [indeterminate MRI evidence will not count and the patient will be eligible]

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • Phase 1/2 Study of REGN4336 (a PSMAxCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Metastatic Castration-Resistant Prostate Cancer. - NCT05125016

    The primary objective of the study is: Dose Escalation: To assess the safety, tolerability, and PK and to determine RP2DR of REGN4336 separately as monotherapy or in combination with cemiplimab Dose Expansion: To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by objective response rate (ORR) per modified Prostate Cancer Working Group (PCWG3) criteria. The secondary objectives of the study are: Dose Escalation: To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by ORR per modified PCWG3 criteria Dose Expansion: 1. To characterize the safety profile in each expansion cohort 2. To characterize the PK of REGN4336 as monotherapy or in combination with cemiplimab In both Dose Escalation and Dose Expansion: 1. To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by PSA decline. 2. To evaluate immunogenicity of REGN4336 in Module 1 and immunogenicity of REGN4336 and cemiplimab in Module 2.

    View All Details
    • Protocol Number:
      082105

    • Principal Investigator:
      Biren Saraiya M.D

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Prostate

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic

    • Drugs Involved:
      R4336 Cemiplimab (REGN2810)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Biren Saraiya M.D

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

      1. Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma 2. Metastatic, castration-resistant prostate cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol 3. Has progressed upon or intolerant to ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy [ADT]) including at least one second-generation anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide, or darolutamide)

    Key Exclusion Criteria:

      1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities 2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy 3. Has received prior PSMA-targeting therapy 4. Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy 5. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments 6. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living [ADLs]) or uncontrolled seizures in the year prior to first dose of study therapy 7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency

    NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

      Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

      For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

      • Rutgers Cancer Institute of New Jersey
    • Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE). - NCT04423211

      Primary Objectives: 1. For patients without PET-evidence of extrapelvic metastases, to evaluate whether the addition of enhanced systemic therapy to SOC salvage RT could prolong PFS. 2. For patients with PET-evidence of extrapelvic metastases, to evaluate whether the addition of metastasis-directed RT to enhanced systemic therapy and SOC salvage RT could prolong PFS. Secondary Objectives: 1. To evaluate overall survival in each arm. 2. To evaluate event-free survival in each arm. 3. To evaluate time to PSA progression using Prostate Cancer Working Group(PCWG) 3 criteria in each arm. 4. To assess the incidence of adverse events with the addition of enhanced systemic therapy in patients without PET-evidence of extrapelvic metastases. 5. To assess the incidence of adverse events with local ablative metastasis-directed RT for PET-positive metastatic disease in patients with PET-evidence of extrapelvic metastases. 6. To estimate the detection rate of PET/CT at the patient and regional level, and to evaluate its concordance with the follow-up FDA approved conventional imaging modalities considered standard-of care (SOC) per institution, including CT, bone scintigraphy, MRI and PET imaging performed as PET/CT and/or PET/MR using 11C-Choline and/or 18F-Sodium Fluoride. 7. To determine the distribution of PET-positive lesions among anatomic sites (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) in patients with post RP BCR, correlated with PSA (level, doubling time, velocity) and other relevant clinical parameters. 8. To determine the value of repeat PET at time of second PSA progression, or 12 months after completion of enhanced systemic therapy, whichever comes first (PET2) to assess response to therapy (enhanced systemic therapy +/- focal RT and/or ADT) compared to standard response assessments (PSA and CIM).

      View All Details
      • Protocol Number:
        082104

      • Principal Investigator:
        Tina Mayer M.D

      • Phase:
        Phase III

      • Scope:
        National

      • Applicable Disease Sites:
        Prostate

      • Therapies Involved:
        Chemotherapy multiple agents systemic

      • Drugs Involved:
        Apalutamide GnRH agonists LEUPROLIDE

        • Contacts:

        • Rutgers University Prinicipal Investigator: Tina Mayer M.D

      Read Inclusion & Exclusion Criteria

      Inclusion Criteria:

      • STEP 0: REGISTRATION ELIGIBILITY CRITERIA
      • Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
      • Patient must have biochemical recurrence (BCR) after RP, with rising PSA defined as follows:
      • If time to biochemical recurrence, (defined as time to first detectable PSA after RP) is < 12 months, a minimum PSA level of >= 0.2 ng/mL and a confirmatory reading of >= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (this includes patients with a persistent PSA reading of at least 0.2 ng/mL)
      • If time to biochemical recurrence, (defined as time to first detectable PSA after RP) is >= 12 months, a minimum absolute PSA of 0.5 ng/mL is required
      • NOTE: Qualifying PSA values per above must be collected at least 4 weeks after RP, with confirmatory persistent or elevated PSA collected at any subsequent time point
      • Patient must be negative or equivocal for extrapelvic metastatic disease by conventional imaging modalities (CIM) (i.e., bone scans, pelvic CT, or pelvic MRI), which must be done within 10-12 weeks prior to registration. Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields
      • Baseline PET/CT scan (PET1) are eligible for this study if the SOC PET scan using 18F-fluciclovine (Axumin) is completed during step 0 registration or up to 12 weeks prior to step 0 registration. The PET/CT scanners must meet scanner qualifications and scans must have an interpretation (or confirmation of an institutional clinical read) by a nuclear medicine physician or radiologist who has undergone 18F-fluciclovine (Axumin) reader training
      • Patient must be a candidate for standard-of-care (SOC) post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (adjuvant)
      • Patient must have the ability to provide written informed consent
      • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
      • Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET/CT scan and radiation treatment planning and delivery
      • Patient must be at a participating institution, which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined PET/CT scanner qualification procedures and received ECOG-ACRIN PET/CT scanner approval
      • Leukocytes >= 3,000/mcL (obtained within 4 weeks prior to registration)
      • Absolute neutrophil count >= 1,500/mcL (obtained within 4 weeks prior to registration)
      • Platelets >= 100,000/mcL (obtained within 4 weeks prior to registration)
      • Total bilirubin =< institutional upper limit of normal (ULN) (obtained within 4 weeks prior to registration)
      • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 4 weeks prior to registration)
      • Glomerular filtration rate (GFR) > 35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine (obtained within 4 weeks prior to registration)
      • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
      • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
      • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
      • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)
      • STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA
      • Patient must have completed a baseline SOC PET scan (PET1) with results of extra-pelvic metastases involvement known (positive or negative)
      • For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)
      • For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields [prostate bed +/- typical whole pelvis]), the number of extra-pelvic lesions must be known (=< 5 or > 5 pelvic lesions)

      Exclusion Criteria:

      • Patient must not have started androgen deprivation therapy for biochemical recurrence prior to baseline study PET/CT imaging
      • Patient must not be enrolled in another therapeutic clinical trial
      • Patient must not have any other malignancy within the last 2 years, other than superficial bladder cancer and skin basal cell carcinoma or cutaneous superficial squamous cell carcinoma that has not metastasized
      • Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year of registration
      • Patient must not have history of inflammatory bowel disease as this would increase risk of complication from radiotherapy or any gastrointestinal disorder affecting absorption
      • Patient must not have had prior radiation therapy

      Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

      For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

      • RWJ University Hospital Somerset
      • Rutgers Cancer Institute of New Jersey
    • Prostate cancer care communication (PCCC): Impact of support person presence on communication during medical appointments

      Purpose This study seeks to better understand communication between patients, their support people, and their oncologist/healthcare providers during prostate cancer treatment appointments. Specifically, this project focuses on how support persons presence in prostate cancer appointments facilitates and/or inhibits communication between patients and providers, and in turn affects communication, mental health (symptoms of depression and anxiety), and quality of life outcomes. This proposal applies relationship and disclosure theoretical frameworks to explore how patients manage information sharing during medical oncology visits. This project is designed to collect data for a subsequent NCI grant proposal to develop a multi-level intervention to facilitate benefits (and limit drawbacks) of support people accompanying patients to oncology visits. We will gather data through surveys of patients with prostate cancer (and some support people) regarding their sharing/withholding patterns with providers and spouses during their treatment visits. Objectives The long-term goal of this research is to develop a brief multi-level intervention to assist patients, support people, and healthcare providers navigating the complexities of these communication interactions during prostate cancer treatment. This project explores how patients share information with their healthcare provider when accompanied by a support person and how patients manage their sharing with their healthcare providers and companions (and vice versa) when attending these medical oncology visits. The project is designed to provide preliminary evidence for a subsequent NCI grant proposal to develop a multi-level intervention. Hypotheses / Research Question(s) Aim 1: Examine prostate cancer patients sharing and withholding of cancer-related symptoms with their healthcare practitioners during medical oncology visits when their support person is present. Hypothesis 1: Prostate cancer patients have different patterns of sharing/withholding to healthcare providers depending on who attends the medical visit (spouses versus other roles). Research question 1: How do prostate cancer patients and their support people differ in communication patterns during the medical visits? Aim 2: Investigate how prostate cancer patients sharing and withholding of cancer-related symptoms with their healthcare practitioners during medical oncology visits is associated with quality of life, including symptoms of depression and anxiety. Hypothesis 2: Prostate cancer patients with different patterns of sharing/withholding to healthcare providers will also have different quality of life outcomes. Aim 3: Explore how communication patterns differ based on dominant language preferences and across underrepresented racial/ethnic groups across the Cancer Institute of New Jersey Catchment area. Research question 2: Do communication patterns differ across non-Hispanic white (English speaking), Hispanic (Spanish speaking), and southeast Asian (Gujarati speaking) men with prostate cancer?

      View All Details
      • Protocol Number:
        132209

      • Phase:
        N/A

      • Scope:
        Local

      • Applicable Disease Sites:
        Prostate

        • Contacts:

        • Archived Organization - Rutgers University Prinicipal Investigator: Kathryn Greene PhD
      • Rutgers Cancer Institute of New Jersey
    Page of 2