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ProtocolTrial 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.
Secondary objectives: (1) Rate of PSA declines. (2) Objective response rate. (3) Progression-free survival. (4) Evaluate the qualitative and quantitative toxicity of abiraterone acetate with and without ABT-888.


A Phase II Study of CTLA Blockade by Ipilimumab plus Androgen Suppression Therapy in Patients with an Incomplete Response to AST Alone for Metastatic Prostate Cancer

Primary endpoint: the proportion of patients who achieve an undetectable PSA (less than 0.2 ng/ml) after initiation of ipilimumab therapy.
Secondary endpoints: include time to progression, time to disease progression by any measure, time to death from any cause, maximum percentage of PSA reduction in each patient, response in measurable disease by RECIST criteria, measure of T cell response by flow cytometry, number of patients with immune related Adverse Events (IRAEs)and correlation between IRAEs and clinical outcomes. The effect of treatment on the ratio of T regulatory cells to T effetor cells and additional measures of immune response will also be determined. To examine correlative biomarkers and their relatioship to clinical outcomes. Potential biomarkers include, but are not limited to CRP, IGF-1 and -2, or FSH.


NCI/CTEP #8983: A Phase I Trial of MK-2206 and Hydroxychloroquine in Solid Tumors, Melanoma, Renal and Prostate Cancer to Examine the Role of Autophagy in Tumorigenesis

Primary - to define the maximum tolerated dose (MTD) of MK-2206 and hydroxychloroquine (HCQ) when used in combination.
Secondary - (1) to determine the side effects and activity of MK-2206 and hydroxychloroquine when used in combination. (2) to determine if hydroychloroquine alters the pharmcokinetics of MK-2206 due to a drug-drug interaction. (3) to validate biomarkers for autophagy detection


Assessment of the Biological Effect of Autophagic Inhibition with Hydroxychloroquine in Prostate Cancer

Primary - (1) to determine the effect of hydroxychloroquine on markers of autophagy in prostate tumor.
Secondary - (1) to determine the distribution of autophagic activity within prostate cancer tissue. (2) to determine the utility of Beclin-1 as a marker of autophagic activity. (3) to assess markers of apoptosis in tumor tissue. (4) to assess PSA as a biochemical endpoint of clinical activity.


ECOG E2810: Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy

1 .To evaluate disease-free survival with pazopanib as compared to placebo, defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause for patients with metastatic RCC with no evidence of disease following metastatectomy.


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
of resistance to full androgen ablation and restore sensitivity to full androgen ablation therapy. NOTE: although this study is randomized to two arms after a lead in period, the study design will independently, and efficiently, test for activity of ABT-263 with full androgen ablation (with abiraterone) and ABT-263 combined with hydroxychloroquine and full androgen ablation (with abiraterone). As a drug development plan, if one or both arms demonstrate restored activity of abiraterone, these data will definitely support future studies that could be powered to compare regimens and/or assess survival to prove effectiveness in a growing population of patients because of the abundant use of androgen axis targeting agents such as abiraterone.


A Randomized, Double-Blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men with Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

Primary Efficacy Objective: to ascertain whether the overall survival of subjects randomized to Arm V+G (PROSTVAC-V/F plus GM-CSF) or to Arm V (PROSTVAC-V/F) is superior to that from subjects randomized to Arm P (placebo control).
Secondary Efficacy Objective: to ascertain whether a greater proportion of subjects randomized to Arm V+G or Arm V remain event-free (radiological progression, pain progression, chemotherapy initiation, or death) at 6 months (or early termination) as compared to the subjects randomized to Arm P.
Safety Objective: to futher characterize the safety and tolerability of PROSTVAC immunotherapy.


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.


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.