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|Protocol||Trial Name and Objective|
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
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
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
NCI/CTEP #9068: A Phase II Multicenter Study of AMG 386 and Abiraterone in Metastatic Castration Resistant Prostate Cancer
Primary Objective: To estimate the treatment effect as measured by progression free survival (PFS) in patients treated with AMG 386 plus abiraterone/prednisone relative to abiraterone/prednisone alone.
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.
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.
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.
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
The proposed study has two primary aims.