Trials / Recruiting
RecruitingNCT04704505
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (estimated)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | radium-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, |
| DRUG | Bipolar Androgen Therapy (BAT) | All Patients will receiveTestosterone Cypionate 400mg IM every 28 days, until progression or unacceptable toxicity. |
Timeline
- Start date
- 2022-04-28
- Primary completion
- 2028-02-01
- Completion
- 2029-02-01
- First posted
- 2021-01-11
- Last updated
- 2026-02-06
Locations
2 sites across 2 countries: United States, Brazil
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04704505. Inclusion in this directory is not an endorsement.