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|Protocol||Trial Name and Objective|
NCI/CTEP 9012: A Randomized Gene Fusion Stratified Phase 2 Trial of Abiraterone with or without ABT-888 for Patients with Metastatic Castration-Resistant Prostate Cancer
Primary Objectives: (1) To evaluate the role of ETS gene fusion as a predictive biomarker for response to hormone therapy (abiraterone) alone or hormone therapy plus PARP-1 targeted therapy (ABT-888) in patients with metastatic castration resistant prostate cancer. (2) To evaluate whether the addition of PARP-1 targeted therapy is superior to hormone therapy alone based on ETS gene fusion status.
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.
A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients with Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer
Primary Objective: to evaluate the objective response rate of MLN8237 for patients with neuroendocrine prostate cancer.
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).
Salvage Therapeutic Radiation with Enzalutamide and ADT in Men with Recurrent Prostate Cancer (STREAM)
Primary Objective: to describe the 2 year progression-free survival in men with recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard androgen-deprivation therapy with salvage radiation therapy and who have had testosterone recovery to greater than 100 at 24 months.
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
Deep Molecular Genomic Mapping of Prostate Cancer in African American Males
To review and analyze the molecular genomics tissue banked prostate specimens from African American males who underwent radical prostatectomy for prostate cancer.
Generating Critical Patient-Centered Information for Decision Making in Localized Prostate Cancer - The CEASAR Follow-up Study
To contact men in the existing CEASAR Cohort and ask them to participate in a 3 year follow-up survey.
Trends in use and Outcomes assessment of radical prostatectomy using nationwide inpatient sample
i. Two databases will be used to compare the costs and outcomes among open radical prostatecteomy (ORP), laparoscopic radical prostatectomy (LRP), and robot-assisted radical prostatectomy (RARP): the Nationwide Inpatient Sample and SEER-Medicare. Through this comparison we propose to determine the most efficient surgical approach for the treatment of localized prostate cancer, to describe patterns of care and variations in outcome
CHD1 Loss as a Marker of Androgen Resistance in Prostate Cancer
1. To analyze genomic alterations of banked prostate cancer specimens from patients treated with androgen deprivation therapy (ADT) for advanced prostate cancer at CINJ.
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
A phase II study of ABT-263/Abiraterone (Arm A) or ABT-263/Abiraterone and Hydroxychloroquine (Arm B) in Patients with Metastatic Castrate Refractory Prostate Cancer (CRPC) and Progression following Abiraterone
ABT-263 with or without hydroxychloroquine will target mechanisms
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
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.
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
The proposed study has two primary aims.
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.
The risk profile and cost analysis of high risk localized prostate cancer patients
The objective of this study is to describe risk profiles and cost patterns of high risk localized prostate cancer patients in the U.S. Specifically, it analyzes the clinical outcomes such as overall mortality, and how baseline risk factors such as age at diagnosis, race, cancer grade, clinical stage and treatment modality predict clinical outcomes. Patient costs at different stages will be analyzed. It delineates clinical and economic outcomes of current management of high risk localized prostate cancer in the U.S.