BAT + Radium-223 for Prostate Cancer
(BAT-RAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two treatments for men with a specific type of advanced prostate cancer that has spread to the bones and resists standard hormone therapy. The study examines whether Bipolar Androgen Therapy (BAT), which involves fluctuating testosterone levels, combined with Radium-223, a radioactive treatment targeting bone cancer, can help manage the disease. Men whose prostate cancer continues to grow despite treatments to lower testosterone and who have bone metastases may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important advancements in prostate cancer care.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Radium-223 is usually well-tolerated by patients with advanced prostate cancer that has spread to the bones. One study found it effective and safe, with most side effects being manageable.
Bipolar Androgen Therapy (BAT), which involves altering testosterone levels, is also under investigation for safety and effectiveness. While researchers continue to gather information on BAT's safety, they are currently testing its combination with Radium-223.
As this is a Phase 2 trial, earlier studies provide some evidence of safety, but more data is needed to confirm how well the combination is tolerated. Participants should consider this when deciding to join the trial.12345Why do researchers think this study treatment might be promising for prostate cancer?
Researchers are excited about Bipolar Androgen Therapy (BAT) combined with Radium-223 for prostate cancer because this combination offers a unique approach compared to traditional treatments like androgen deprivation therapy or chemotherapy. Unlike standard therapies that focus solely on reducing testosterone levels to slow cancer growth, BAT involves alternating high and low doses of testosterone, potentially sensitizing cancer cells to radiation. Additionally, Radium-223 targets bone metastases, which are common in advanced prostate cancer, by emitting radiation directly at cancer cells in the bones, minimizing damage to surrounding healthy tissue. This dual approach could provide a more effective and targeted attack on prostate cancer, particularly for those with bone metastases.
What evidence suggests that BAT plus Radium-223 could be an effective treatment for prostate cancer?
Research has shown that Bipolar Androgen Therapy (BAT) can be effective for aggressive prostate cancer. BAT involves administering high doses of testosterone, which may benefit prostate cancer cells unresponsive to standard hormone treatments. Studies have found that BAT is generally well-tolerated and may be particularly effective depending on previous treatments.
Radium-223 has been proven to extend the lives of men with metastatic castration-resistant prostate cancer (mCRPC). It specifically targets cancer that has spread to the bones, a common occurrence in prostate cancer, and can help delay or improve bone-related symptoms. One study demonstrated that Radium-223 increased survival time and reduced bone problems, making it a valuable treatment option for mCRPC. In this trial, participants will receive both BAT and Radium-223, offering a promising approach to managing this type of prostate cancer.678910Who Is on the 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
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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