BAT + Radium-223 for Prostate Cancer
(BAT-RAD Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must continue taking bone health agents like zoledronic acid or denosumab during the study. If you are on warfarin, you cannot participate, but other anticoagulants are allowed.
What data supports the effectiveness of the treatment BAT + Radium-223 for prostate cancer?
Research shows that bipolar androgen therapy (BAT) can be safely used in men with prostate cancer that no longer responds to standard hormone treatments, with 30%-40% of patients experiencing positive responses. Additionally, BAT may help restore the effectiveness of other prostate cancer treatments.12345
Is BAT safe for humans?
What makes the BAT + Radium-223 treatment unique for prostate cancer?
The BAT + Radium-223 treatment is unique because it combines bipolar androgen therapy (BAT), which involves rapidly alternating testosterone levels, with Radium-223, a radioactive substance that targets bone metastases. This approach not only aims to manage castration-resistant prostate cancer but also potentially restores sensitivity to other treatments and reduces prostate-specific antigen levels.12356
Research Team
Samuel Denmeade, M,D
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Hospital
Pedro Isaacsson Velho, M,D
Principal Investigator
Moinhos de Vento Hospital
Eligibility Criteria
Men with advanced prostate cancer that has spread to the bones and is resistant to hormone therapy can join. They should have tried hormone-blocking treatments, but only one newer drug like abiraterone or enzalutamide. No recent chemo for mCRPC, no major health issues unrelated to cancer, and they must not be using strong painkillers like morphine.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Radium-223 at a dose of 55 kBq/kg IV every 28 days for 6 cycles, plus Testosterone Cypionate 400mg IM every 28 days, until progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Bipolar Androgen Therapy (BAT)
- Radium-223
Bipolar Androgen Therapy (BAT) is already approved in United States, European Union for the following indications:
- None approved; experimental use in clinical trials for metastatic castration-resistant prostate cancer (mCRPC)
- None approved; experimental use in clinical trials for metastatic castration-resistant prostate cancer (mCRPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD