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Brief Title: Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official Title: Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC) (BAT-RAD Study)
Study ID: NCT04704505
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: Yes
Amber Michalik, Baltimore, Maryland, United States
Moinhos de Vento Hospital, Porto Alegre, , Brazil
Name: Pedro Isaacsson Velho, M,D
Affiliation: Moinhos de Vento Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Samuel Denmeade, M,D
Affiliation: Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Hospital
Role: PRINCIPAL_INVESTIGATOR