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ProtocolTrial Name and Objective
051403

A first-in-human phase I single-agent open-label dose-escalation study of every three-week dosing of oral ONC201 in patients with advanced solid tumors

Dose escalation:
To determine the recommended maximal tolerated dose (MTD) or recommended phase II dose of single agent ONC201 orally once every three weeks

Dose expansion:
To characterize the safety and tolerability of ONC201 in patients with tumors that have a high frequency of PI3 kinase pathway or RAS signaling activation (metastatic castrate resistant prostate cancer, metastatic renal cell carcinoma, melanoma, glioblastoma multiforme, breast cancer).
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081405

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.
Secondary Objectives: (1) to determine the proportion of men at 1, 2 and 3 years with a PSA of less than 0.1 ng/mL and testosterone receovery to greater than 100. (2) to describe the 3 year progression-free suvival in men receiving combined enzalutamide and standard androgen-deprivation therapy with salvage radiation therapy and who have had testosterone recovery to greater than 100. (3) to describe the biochemical (PSA) progression free survival over time. (4) to describe the PSA nadir. (5) to describe the time to testosterone recovery. (6) to describe the safety profile of combination enzalutamide, ADT, and XRT.
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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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081305

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.
Secondary Objective: to determine the overall survival, progression free survival, PSA response rate, circluting tumor cell (CTC) response, and serum neuroendocrine markers in response to therapy.
Exploratory objectives: to evaluate molecular biomarker archival and metastatic tissue, including IHC and FISH for Aurora kinase A and N-myc overexpression and amplification, meuroendocrine markers, AR status, ERG fusion, and other genomic mutations determined by sequencing. To evaluate plasma DNA for AURKA and MYCN amplification.
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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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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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081210

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.
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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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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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131326

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.
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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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