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Brief Title: Maintaining Suppression of Testosterone With Transdermal Estradiol Gel
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of BHR-200 (0.36% Transdermal Estradiol Gel) for the Maintenance of Testosterone Suppression in Men With Advanced Androgen-Sensitive Prostate Cancer
Study ID: NCT02349386
Brief Summary: The objective of this clinical study is to evaluate the safety and efficacy of three different doses of BHR-200 (0.36% transdermal estradiol gel) compared to placebo for the maintenance of testosterone (T) suppression in men with advanced androgen-sensitive prostate cancer.
Detailed Description: This is a multi-center, randomized, double-blind, placebo-controlled, dose finding study in men with advanced androgen-sensitive prostate cancer. Patients who give informed consent will have screening evaluations, and if fulfilling the entry criteria, will be randomized to one of 4 treatment groups: 1mL, 2mL or 3mL of 0.36% BHR-200 (transdermal estradiol gel) or Placebo. Study drug will be initiated on the day they were scheduled to receive next depot GnRH agonist injection. Patients will be offered low-dose radiation to aid in the prevention of gynecomastia. Patients will apply the study drug once per day. The first dose of study gel will be applied under the supervision of the PI/designee. Subsequent doses will be self-administered daily by the patient until he is no longer chemically castrated (testosterone levels increase above 50 ng/dL), a rise over baseline PSA of \> 0.5 ng/mL is observed, or he has completed 52 weeks of study drug administration. At the conclusion of study participation, patients will be advised to resume standard of care treatment under the supervision of their healthcare provider. While on treatment, patients will be evaluated at Day 1 and every 2 weeks, for the first 24 weeks and every 4 weeks thereafter with a final post-treatment follow-up visit 2 weeks (+/- 1 week) post last dose administration.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Urological Associates of Southern Arizona, Tucson, Arizona, United States
South Florida Medical Research, Aventura, Florida, United States
Advanced Urology Institute, Daytona Beach, Florida, United States
Adult Pediatric Urology, PC, Council Bluffs, Iowa, United States
Adult Pediatric Urology, PC, Omaha, Nebraska, United States
Delaware Valley Urology, Voorhees, New Jersey, United States
AccumetRX Clinical Trials, Albuquerque, New Mexico, United States
Associated Medical Professionals of NY (AMP of NY), Syracuse, New York, United States
Eastern Urological Associates, Greenville, North Carolina, United States
Urologic Consultants of Southeastern Pennsylvania (UCSEPA), Bala-Cynwyd, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology Clinics of North Texas, Dallas, Texas, United States
Name: Roland Gerritsen van der Hoop, MD, PhD
Affiliation: BHR Pharma, LLC
Role: STUDY_DIRECTOR