Open Clinical Trials for Patients With Prostate Cancer

Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but a significant number of trials are now recruiting patients from those patient populations. More than 63,000 open trials currently are listed on the ClinicalTrials.gov website. Many explicitly recruit patients from the VA (461 studies), the military (437 studies), and IHS (2 studies). The VA Health Services Research and Development department alone sponsors > 250 research initiatives, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities.

The clinical trials listed below are all open as of July 25, 2016; have at least 1 VA, DoD, or IHS location recruiting patients; and are focused on treatment for prostate cancer. For additional information and full inclusion/exclusion criteria, please consult https://clinicaltrials.gov.

Optimizing Veteran-Centered Prostate Cancer Survivorship Care

This study will provide much needed information about how to optimize the quality of care and quality of life of veterans who are survivors of prostate cancer.

ID: NCT01900561

Sponsor: VA Office of Research and Development

Location (contact): VA Ann Arbor Health Care System, Michigan (Tabitha Metreger); St. Louis VAMC, Missouri; John Cochran Division (Robert L. Grubb); VA Pittsburgh Healthcare System, University Drive Division, Pennslyvania (Bruce S. Ling)

Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial

Vitamin D promotes the differentiation of prostate cancer cells and maintains the differentiated phenotype of prostate epithelial cells. The results of the investigators’ clinical studies indicate that vitamin D3 supplementation results in a decrease of positive cancer cores at repeat biopsy in subjects with low-risk prostate cancer. The investigators hypothesize that veterans who have early-stage prostate cancer and who take vitamin D3 at 4,000 international units per day (intervention group) will show an improvement in the number of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of undergoing definitive treatment (prostatectomy or radiation therapy), compared to veteran subjects taking placebo (control group).

ID: NCT01759771

Sponsor: VA Office of Research and Development

Location (contact): Ralph H. Johnson VAMC, South Carolina (M. Rita I. Young)

An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African American and Caucasian Males

This study will examine the association of genetic variants and gene expression patterns with the risk of prostate cancer. It will include genotype analysis of blood DNA from 600 patients with the disease and from 600 healthy people, and there will be a gene expression analysis of prostate tumors.

ID: NCT00342771

Sponsor: National Cancer Institute

Location (contact): Baltimore VAMC, Maryland (Alexander Richard)

MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer

Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and targeted biopsies for men with low-risk prostate cancer on active surveillance with any volume Gleason Score 6, but no prior MRI imaging of the prostate.

ID: NCT02564549

Sponsor: Virginia Commonwealth University

Location (contact): Hunter Holmes McGuire VAMC, Virginia (Drew Moghanaki)

Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

ID: NCT01949337

Sponsor: Alliance for Clinical Trials in Oncology

Location (contact): Naval Medical Center, California (Preston Gable); San Francisco VAMC, California (Terence Friedlander); VA Connecticut Healthcare System-West Haven Campus (Herta Chao); Washington DC VAMC (Anthony Arcenas); Edward Hines, Jr. VA Hospital, Illinois (Elizabeth Henry); Minneapolis VA Health Care System, Minnesota (Sharon Luikart); Kansas City VAMC, Missouri (Peter Van Veldhuizen); VA New Jersey Health Care System (Victor Chang); Bronx VAMC, New York (Yeun-Hee Park); VA Western New York Healthcare System-Buffalo (Lynn Steinbrenner); Syracus VAMC, New York (Namita Chittoria); Durham VAMC, North Carolina (Daphne Friedman); White River Junction VAMC, Vermont (Alexander Fuld); Clement J. Zablocki VAMC, Wisconsin (Elizabeth Gore)