RecruitingPhase 2NCT04704505

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

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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

47 participants

Start Date

Apr 28, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Prostate Adenocarcinoma Prostate Adenocarcinoma Castration-resistant

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is combining two treatments — bipolar androgen therapy (BAT, which uses high-dose testosterone) and radium-223 (a radioactive drug targeting bone) — for men with prostate cancer that has spread to the bones and is no longer responding to hormone therapy (castration-resistant). **You may be eligible if...** - You are a man with prostate cancer confirmed by biopsy - Your cancer has spread to bone (at least one bone lesion on scan) - Your cancer is castration-resistant (progressing despite very low testosterone levels) - You have had prior treatment with androgen receptor-targeted therapy **You may NOT be eligible if...** - You have spread to organs other than bone (visceral metastases) - You have had prior radium-223 treatment - You have significant bone marrow problems or severe other organ dysfunction - Your testosterone levels are not in the castrate range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONradium-223

Radium-223 is an alpha-particle-emitting bone-targeted therapy. All patients will receive Treatment with Radium-223 at a dose of 55 kBq per kilogram of body weight IV every 28 days, for 6 cycles,

DRUGBipolar Androgen Therapy (BAT)

All Patients will receiveTestosterone Cypionate 400mg IM every 28 days, until progression or unacceptable toxicity.