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ProtocolTrial Name and Objective
080901

Phase I/II Randomized Trial of LBH589 (Pabinostat) at Two Dose Levels Combined with Bicalutamide (Casodex) in Men with Castration-Resistant Prostate Cancer

The purpose of this study is to determine the safety (Phase 1) and efficacy, or effectiveness (Phase 2) of an investigational drug, LBH589, in combination with Casodex® for the treatment of prostate cancer. The purpose of the Phase 1 study is to determine the maximum tolerated dose of investigational drug LBH589 in combination with Casodex®. The purpose of the Phase 2 study is to determine the effectiveness of investigational drug LBH589 in combination with Casodex® at the maximum tolerated dose, compared to a lower dose of LBH589 in combination with Casodex®.
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081205

Phase I/II Study of Safety and Efficacy of Muscadine Plus (MPX) in Men with Prostate Cancer: A Randomized, Double-Blind Placebo Controlled Study of the Effects of Two Doses of MPX Capsules on Rising Prostate-Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer: Phase II

Phase II Primary Objective: To define the effects of placebo and two different daily doses of Muscadine Plus (MPX) on prostate specific antigen doubling time (PSADT) in men who have rising PSA after initial definitive therapy for localized prostate cancer.
Phase II Secondary Objectives: (1) To estimate other measures of PSA kinetics including a)log PSA slope, b)PSAV, c)proportion of men whose PSADT increases greater than 33%, d)greater than 50% reduction in PSA compared with baseline. (2) To assess the adherence, tolerability and toxicity of MPX in both arms of the study.
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081209

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.
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081213

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.
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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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081212

A Pilot Study To Assess Feasbility Of Collection Of Prostate Cancer Cells In Peripheral Blood Using A Biotinylated Inhibitor (Biotin-Peg12-Ctt-54) Of The Enzyme-Biomarker PSMA And Culturing The Captured Prostate Cancer Cells In A Zebrafish Xenograft

1. To determine the feasibility of capturing prostate cancer cells obtained from specimens of patient derived peripheral blood using a novel Biotin-PEG12-CTT-54 based capture technique

2. To determine the feasibility of culturing captured prostate cancer cells using the Biotin-PEG12-CTT-54 based capture in zebrafish.

3. To study the characteristics of captured stem cells including expression of the androgen receptor and other potential markers of sensitivity to prostate cancer therapeutics

4. To study the effects of therapeutics on prostate cancer in a zebrafish model.
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051105

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
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121102

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.
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081208

A Phase 3, Randomized, Double-Blind, Controlled Trial of Cabozantinib (XL184) vs. Mitoxantrone Plus Prednisone in Men with Previously Treated Symptomatic Castration-Resistant Prostate Cancer

The objectives of the study are to evaluate the safety and efficacy of cabozantinib compared with mitoxantrone plus prednisone. Efficacy will be measured by (1) proportion of subjects with pain response at week 6 confirmed at week 12. (2) Bone scan response at week 12 per IRF (primary analysis designates subjects with soft tissue progression as non-responders). (3) Overall survival
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081214

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.
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081308

SWOG S1216: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy +TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostrate Cancer

Primary: overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide

Secondary:
a. To compare progression free survival (as defined in Section 10.5) between the two arms
b. To compare distributions of PSA response (< 0.2 vs. 0.2-4.0 vs. > 4.0 ng/ml) between the treatment arms at 7 months post-randomization.
c. To compare the qualitative and quantitative adverse events from each treatment arm.
d. To characterize the long-term survival in both treatment arms after 10 years of follow-up.
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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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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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