Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)

This is a single-arm, multicenter open label, international, phase II study of Bipolar Androgen Therapy (BAT) plus Radium-223 (RAD) in men with metastatic castration-resistant prostate cancer (mCRPC). Men with mCRPC with progressive disease (radiographically and/or biochemically) who have been treated with gonadotropin-releasing hormone (GnRH)-analogue (LHRH agonists/antagonists) continuously or bilateral orchidectomy will be enrolled in this study. Previous antiandrogen therapies are permitted, but no more than one (such as abiraterone, enzalutamide, apalutamide, darolutamide). All patients will receive treatment with Radium-223 at a dose of 55 Kilobecquerel (kBq) per kilogram of body weight IV every 28 days, for 6 cycles, plus Testosterone Cypionate 400mg Intramuscular (IM) every 28 days, until progression or unacceptable toxicity.

NCT Number	NCT04704505
Lead Sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Collaborators: Bayer
Conditions	Prostate Adenocarcinoma, Metastatic Prostate Adenocarcinoma, Castration-resistant
Enrollment	47 participants
Start Date	2022-04-28
Primary Completion	2028-02 (estimated)
Study Completion	2029-02 (estimated)
Updated on ClinicalTrials.gov	2026-02-06