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ProtocolTrial Name and Objective
081301

A Phase II, Randomized, Three-Arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients with Prostate Cancer with a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy

The primary endpoint for each cohort is progression-free survival (PFS) at 18 months from the start of randomization (PSA0). PFS is defined as an undetectable (less than or equal to 0.05 ng/mL) PSA with a non-castrate level of testosterone (greater than 150 ng/dL). Pathological lymph nodes (whether target or non-target) must also have reduction in short axis to less than 10mm (Compelte Response per RECIST) in order to meet the criteria for PFS.
Secondary endpoints: (1) PSA response rate (Percentage of patients with an undetectable PSA at 8 months from PSA0). (2) Effects of each arm on overall quality of life, with particular attention to libido, potency, anxiety, depression, hot flashes and fatigue. (3) Frequency and intensity of non-hematologic adverse events. (4) Testosterone and leuteinizing hormone (LH) recovery rates.
Tertiary endpoint: Correlative tissue analysis with clinical outcomes while on study treatment.
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081403

Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed with Metastatic Prostate Cancer

To determine the safety and feasibility of cytoreductive prostatectomy in men with newly diagnosed clinical TxN1Mx or TxNxM1 prostate cancer (herein, collectively referred to as metastatic prostate cancer).

Time to PSA nadir and castration resistance following cytoreductive prostatectomy and
subsequent standard systemic therapy, androgen deprivation.
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081501

A Phase 2 Randomized Discontinuation Trial in Patients with Hormone-Dependent Rising Prostate-Specific Antigen Progression After Local Therapy For Prostate Cancer Evaluating the Synergy of Metformin Plus Aspirin (PRIMA Trial)

1.1 Primary Endpoints
1.1.1 To determine the effect of metformin and aspirin on the change in PSA progression in men with rising PSA after definitive therapy for localized prostate cancer and stable disease during a run-in period with the study regimen.

1.2 Secondary Endpoints
1.2.1 To determine the feasibility and safety of administering metformin and aspirin
1.2.2 To determine the effect of metformin and aspirin on PSA levels and the serum obesity-related PCa biomarkers (insulin, IGF-1, IL-1â, IL-6, and TNF-á)
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081510

PARTIQoL: Prostate Advanced Radiation Technologies Investigating Quality of Life. A Phase III Randomized Clinical Trial of Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer.

Compare the reduction in mean EPIC bowel scores for men with low or intermediate risk PCa treated with PBT versus IMRT at 24 months following radiation (where higher scores represent better outcomes).
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081211

A randomized, double blind, multicenter, parallel-group, phase III study to evaluate efficacy and safety of DCVAC/PCa versus placebo in men with metastatic castration resistant prostate cancer eligible for 1st line chemotherapy

Primary
The primary objective is to show superiority of treatment with DCVAC/PCa in addition to Standard of Care Chemotherapy over placebo in addition to Standard of Care Chemotherapy in men with mCRPC as measured by OS.
Secondary
The secondary objectives include assessments of safety, time to tumour progression, time to prostate-specific antigen progression, progression free survival, occurrence of skeletal related events (SRE), proportion of patients requiring second line treatment introduction
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081402

ARN-509-003: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer (SPARTAN)

To demonstrate superiority in the metastasis-free survival (MFS) of men with high risk Non metastatic -CRPC treated with ARN-509 versus placebo

Main secondary objective
To demonstrate superiority in the metastasis-free survival (MFS) of men with high risk NM-CRPC treated with ARN-509 versus placebo
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051408

A Phase 1-2 Dose-Escalation and Safety Study of ADXS31-142 Alone and of ADXS31-142 in Combination with Pembrolizumab (MK-3475) in Patients with Previously Treated Metastatic Castration-Resistant Prostate Cancer

Primary objectives: Part A: to evaluate the safety and tolerability of ADXS31-142 monotherapy and select the RP2D in subjects with mCRPC. Part B: to evaluate the safety and tolerability of ADXS31-142 in combination with pembrolizumab (MK-3475) and to establish the RP2D for this combination in subjects with mCRPC.
Secondary Objective: to evaluate anti-tumor activity and progression free survival (PFS) signal of ADXS31-142 monotherapy and ADXS31-142 + pembrolizumab (MK-3475) combination therapy using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) and Prostate Cancer Working Group 2 (PCWG2) criteria to inform design of a subsequent randomized Phase 2 trial.
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081504

A Phase 2, Open-Label, Single-Arm Study of 18F-Sodium Fluoride PET/CT Bone Imaging in Enzalutamide-Treated Chemotherapy-Naive Patients with Bone-Metastatic Castration-Resistant Prostate Cancer

Primary Objective: To evaluate 18F-sodium fluoride positron-emission tomography/computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response in metastatic bone lesions at the time of disease progression (prostate specif antigen [PSA], bone or soft tissue, or other clinically relevant progression) or at 2 years without progression after treatment initiation in patients who are chemotherapy-naive in the castration-resistant setting with progressive bone-metastatic castration-resistant prostate cancer (CRPC) treated with enzalutamide.
Secondary Objective: To evaluate heterogeneity of response in metastatic bone lesions at the time the primary objective is assessed.
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081508

A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer: The TRANSFORMER Trial

Primary Objective: To determine if treatment with supraphysiologic testosterone (T) will improve radiographic progression free survival compared to enzalutamide in asymptomatic men with evidence of progressive metastatic CRPC post-treatment with abiraterone.
Secondary Objectives: (1) Further investigate the safety of cyclical parenteral testosterone in asymptomatic men with recurrent castrate resistant prostate cancer. (2) PSA response rate. (3) Objective response rate in patients with measurable disease on CT scan using RECIST criteria. (4) Time to PSA progression to each arm of therapy based on PCWG2 criteria. (5) PSA response rate to enzalutamide post-BAT. (6) PSA response rate to BAT post-enzalutamide. (7) Comparison of effect of each treatment arm on quality of life as assessed by patient completion of validated instruments.
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131107

Randomized Controlled Trial (RCT) of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors. A Study of The Cancer Institute of New Jersey Oncology Group (CINJOG)

We propose to develop and evaluate a comprehensive and innovative multimedia program designed to facilitate the post-treatment transition into survivorship. The design of the proposed intervention, the Virtual Survivorship Resource Center for Prostate Cancer (VSRC-PC), will be theoretically based on the team's Cognitive-Social Health Information Processing Model. The VSRC-PC will focus on promoting adaptive coping within four key post-treatment domains: 1) Physical Dysfunction (e.g., physical symptoms); 2) Emotional Well- Being (e.g., fear of recurrence); 3) Interpersonal Concerns (e.g., sexual intimacy issues); and 4) Practical Barriers (e.g., medical follow-up challenges). The proposed research will be the first RCT to evaluate not only a comprehensive but also highly disseminable and self-sustaining intervention for facilitating post-treatment adaptation among early-stage Pca survivors. The proposed research will be the first RCT to evaluate not only a comprehensive but also highly disseminable and self-sustaining intervention for facilitating post-treatment adaptation among early-stage Pca survivors.
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131023

Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer

The proposed study has two primary aims.
Aim 1: To evaluate the impact of an Intimacy-Enhancing Couples' intervention (IEC) versus a General Health and Wellness Intervention (GHW) and a Usual care control (UC) on patient and partner psychological and relationship outcomes.
Aim 1a.: To determine whether relationship length, pre-intervention relationship satisfaction, and men's pre-intervention masculinity moderate the effects of IEC on couples' psychological and relationship outcomes.
Aim 2: To evaluate whether IEC has an effect on couples' communication and intimacy when compared with GHW and UC and to determine whether changes in relationship communication and intimacy mediate changes in couples' psychological and relationship outcomes.
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