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)
S1216, Phase III ADT+TAK-700 vs ADT+ Bicalutamide for Metastatic Prostate Cancer
The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy + TAK-700 vs ADT + bicalutamide.
ID: NCT01809691
Sponsor: Southwest Oncology Group
Location (contact): Washington DC VAMC (Anthony Arcenas); Edward Hines, Jr. Hines VA Hospital, Illinois (Elizabeth Henry); Kansas City VAMC, Missouri (Peter Van Veldhuizen); VA New Jersey Health Care System (Victor Chang); VA New York Harbor Healthcare System-Brooklyn Campus (Andrea N. Leaf); VA Western New York Health Care System-Buffalo (Lynn Steinbrenner); Portland VAMC, Oregon (Julie N. Graff); Michael E. DeBakey VAMC, Texas; Tripler Army Medical Center, Hawaii (Jeffrey L. Berenberg)
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.
ID: NCT02206334
Sponsor: NRG Oncology, National Cancer Institute
Location (contact): Clement J. Zablocki VAMC, Wisconsin (Elizabeth Gore)
Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy
This phase II trial studies ciprofloxacin compared to an inactive treatment (placebo) in diagnosing prostate cancer in patients undergoing removal of prostate cells or tissues for examination (biopsy). Ciprofloxacin is an antibiotic, a type of drug used to treat infections caused by bacteria. Giving ciprofloxacin to patients undergoing a prostate biopsy may help to lower abnormal prostate-specific antigen levels caused by bacterial infection of the prostate gland and may or may not affect the detection rate of prostate cancer.
ID: NCT02252978
Sponsor: Comprehensive Cancer Center of Wake Forest University
Location not yet recruiting (contact): W.G. (Bill) Hefner VAMC, North Carolina (Kethandapatti C. Balaji)
Prostate Active Surveillance Study
The Prostate Active Surveillance Study (PASS) is a research study for men who have chosen active surveillance as a management plan for their prostate cancer. Active surveillance is defined as close monitoring of prostate cancer with the offer of treatment if there are changes in test results. This study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.
ID: NCT00756665
Sponsor: University of Washington
Location (contact): VA Puget Sound Health Care System, Washington (Branda Levchak
Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy X-rays to kill tumor cells. This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.
ID: NCT01368588
Sponsor: Radiation Therapy Oncology Group
Location (contact): VA Long Beach Healthcare System, California (Samar H. Azawi); Clement J. Zablocki VAMC, Wisconsin (Elizabeth Gore)
Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery
This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical prostatectomy. Side effects of green tea extract and quercetin in combination with green tea extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies quercetin was found to enhance the anticancer effects of green tea. This trial is designed to translate these findings forward in a short-term human intervention trial.
ID: NCT01912820
Sponsor: Jonsson Comprehensive Cancer Center
Location (contact): VA Greater Los Angeles Healthcare System, California (William Aronson)
A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer (PREDICT)
The primary purpose of this research is to describe patient characteristics predictive of an imaging study positive for distant metastases in patients with castration-resistant prostate cancer and no known distant metastases.
ID: NCT01981109
Sponsor: Dendreon
Location (contact): VA Greater Los Angeles Healthcare System, California (Amy Smallcomb)