Clinical Trial

Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)

Study acronym: ExBAT
Active, Not Recruiting Phase 2
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Summary
This is a multi-center, open-label, phase II, single-arm trial evaluating combination of darolutamide and high testosterone doses - extreme bipolar androgen therapy (ExBAT) - in patients with metastatic castration-resistant prostate cancer (mCRPC).
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-09-16; most recent amendment 2026-02-11.
Status change: Recruiting → Active, Not Recruiting 2023-05-23
Status change: Not Yet Recruiting → Recruiting 2021-06-14
Trial Details
NCT Number NCT04558866
Lead Sponsor Latin American Cooperative Oncology Group
Collaborators: Bayer
Conditions Prostate Cancer
Enrollment 51 participants
Start Date 2021-06-09
Primary Completion 2024-03-15 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-12