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Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study acronym: BAT-RAD
StatusRecruiting
PhasePhase 2
Started2022-04-28
View on ClinicalTrials.gov ↗

Amendment history

2026-02-03
Study Status v14
Primary completion date2026-02→2028-02
Completion date2027-02→2029-02
2025-06-17
2 amendments v12-v13
2 re-verifications since 2024-06-17, no change to tracked fields
2024-05-09
Study Identification, Study Status, Sponsor/Collaborators v11
Collaborators+5 characters
Bayer
2023-04-12
Study Status, Contacts/Locations v10
Study sitescontacts updated at 1 of 2 sites
2022-04-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v9
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-03-31→confirmed 2022-04-28
Study sites2 entries, revised
JohnsAmber Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer CenterMichalik
Show 8 earlier versions
2022-03-02
Study Status v8
Start date2022-02-01→2022-03-31
2021-12-10
Study Status v7
Primary completion date2025-12→2026-02
Completion date2026-12→2027-02
Start date2021-12-01→2022-02-01
2021-10-20
Study Identification, Study Status v6
Primary completion date2025-07→2025-12
Completion date2026-07→2026-12
Start date2021-09-01→2021-12-01
2021-08-03
Study Status v5
Start date2021-07→2021-09-01
2021-05-24
Study Identification, Study Status v4
Primary completion date2025-05→2025-07
Completion date2026-05→2026-07
Start date2021-05→2021-07
2021-04-08
Study Status v3
Primary completion date2025-04→2025-05
Completion date2026-04→2026-05
Start date2021-04→2021-05
2021-02-17
Study Status v2
Primary completion date2025-02→2025-04
Completion date2026-02→2026-04
Start date2021-02→2021-04
2021-01-19
Study Status, Contacts/Locations v1
Study sitescontacts updated at 1 of 2 sites
2021-01-08
Original filing
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.
Trial Details
NCT Number NCT04704505
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Bayer
Conditions Prostate Adenocarcinoma, Metastatic Prostate Adenocarcinoma, Castration-resistant
Enrollment 47 participants
Start Date 2022-04-28
Primary Completion 2028-02 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-02-06