Phase II Study of Bipolar Androgen Therapy Plus Radium-223 for Men with Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

This research evaluates Bipolar Androgen Therapy BAT combined with Radium-223 RAD in men who have metastatic castration-resistant prostate cancer mCRPC with progressive disease despite previous hormone therapy. Men eligible have been treated continuously with gonadotropin-releasing hormone analogues or had surgical removal of testes and may have had up to one previous antiandrogen therapy. This international, open-label, phase II study aims to explore this combined treatment approach in this patient population. Participants will receive Radium-223 intravenously at a dose of 55 kBq per kilogram of body weight every 28 days for six cycles. Alongside this, they will be given Testosterone Cypionate 400 mg by intramuscular injection every 28 days until disease progression or unacceptable side effects occur. This single-arm study does not involve comparison groups, focusing on the combined treatments effect. During the study, participants will undergo regular assessments including bone scans, PSA blood tests, and quality of life questionnaires such as the EQ-5D-3L, FACT-P, and BPI-SF at baseline and various treatment cycles. Researchers will monitor disease progression, survival, skeletal events, and safety over a 24-month period, with careful tracking of adverse events and treatment impact. Participants will be followed until progression or for up to 10 months for safety evaluations.

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