
Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer...
Prostatic NeoplasmsThis study is for men who have prostate cancer and have failed local therapy or are not a candidate for prostatectomy or radiation therapy. The purpose of this research study is to assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus chemotherapy. Degarelix is the hormone blocking drug that will be used. Doxorubicin, Ketoconazole, Docetaxel and Estramustine are the chemotherapy drugs that will be used. The drugs used in this study are approved by the Food and Drug Administration (FDA). Participants will be treated with ADT plus chemotherapy for three, four, or five 8-week cycles (12, 18, or 24 months). The number of cycles of chemotherapy they receive and the number of months they receive ADT will be based on their disease. The current standard treatment is ADT and chemotherapy. What differs in this research study is the cycling and combination of chemotherapy drugs chosen. The drugs chosen for this study have fewer side effects and are believed to provide maximum benefit.

BrUOG 337: Olaparib Prior to Radical Prostatectomy For Advanced Prostate Cancer Defects in DNA Repair...
Prostate CancerAdenocarcinoma of the ProstateThis study will evaluate approximately 3 months of treatment with the drug olaparib in patients with prostate cancer. A capsule formulation of olaparib (tradename Lynparza™) is approved by the United States Food and Drug Administration (FDA) for the treatment of women with advanced BRCA-mutated ovarian cancer. Olaparib is an investigational drug in prostate cancer. A tablet formulation of olaparib is being tested in this study. It is a new formulation which is more convenient for patients than the approved capsule formulation because fewer tablets of olaparib need to be taken daily than with capsules. The purpose of the study is to evaluate whether olaparib can reduce prostate cancer with defects in DNA repair genes when olaparib is given for approximately 3 months before surgery.

Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate...
Prostate CancerThis is a prospective randomized phase II clinical trial where patients who are receiving enzalutamide in the pre-chemotherapy space are randomized upon objective progression (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same combination plus enzalutamide. The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel in patients who failed or progressed while on enzalutamide would increase progression-free survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL) using validated scales.

Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer...
Recurrent Prostate CarcinomaStage I Prostate Cancer3 moreThis randomized phase II trial studies how well metformin hydrochloride and aspirin work in treating patients with hormone-dependent prostate cancer that has progressed after surgery or radiation therapy. Metformin hydrochloride and aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving metformin hydrochloride and aspirin together can slow the growth of prostate cancer.

A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC
Prostate Cancer MetastaticThis phase IIb study is a randomized, double-blind, placebo-controlled multi-center study evaluating efficacy and tolerability of Osteodex of patients with metastatic castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known substances; dextran, alendronate and guanidine. The objective of the study is to evaluate the relative change of response markers to bone metabolism (B-ALP and S-P1NP) The following objectives will also be evaluated: overall survival, PSA response, other response markers related to bone metabolism (S-CTX and osteocalcin), safety, tolerability, pain and quality of life.

A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer
Prostate CancerThis research study is studying a combination of drugs as a possible treatment for castration-resistant prostate cancer. The interventions involved in this study are: Docetaxel (a type of chemotherapy) Apalutamide (the study medication, also known as ARN-509) Prednisone (a corticosteroid given to prevent reactions to docetaxel). Leuprolide acetate (also known as Lupron, a GnRH agonist or similar drug which is standard of care, causes chemical castration which greatly lowers the level of testosterone in the body)

Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer
Prostate CancerThe purpose of this study is to determine whether GTx 758 is effective in achieving and maintaining castrate testosterone levels in men with advanced prostate cancer.

Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) Patients
Castrate Resistant Prostate CancerThe study has three parts. Part 1 is a dose escalation to investigate the safety and tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.

Abiraterone Acetate Trial in African American Prostate Cancer Patients
Prostate CancerThis is a pilot study of abiraterone acetate in African American/Black patients with castration-resistant prostate cancer. The primary objective is to determine the correlation between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in African American patients with castration-resistant prostate cancer treated with abiraterone acetate. Patients will receive abiraterone acetate until the time of disease progression, in the absence of prohibitive toxicities. Patients will be followed for disease progression and survival.

External Beam Radiation With or Without Chemotherapy to Treat High Risk Prostate Cancer
Prostate CancerThe purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy.