Condition: Prostate Adenocarcinoma · Metastatic Prostate Adenocarcinoma · Castration-resistant · Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.
This description comes directly from the study's public registry record.
Rana Sullivan, RN · 410-614-6337 · ProstateCancerClinicalTrials@live.johnshopkins.edu
Amber Michalik, BA · 667-306-8336 · ProstateCancerClinicalTrials@live.johnshopkins.edu
Always discuss trial participation with your own doctor first.
| Amber Michalik | Baltimore, Maryland, United States | Recruiting |
| Moinhos de Vento Hospital | Porto Alegre, Brazil | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT04704505