drugset
drugset / Trial / NCT04558866

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

NCT04558866 ↗

Phase 2 Active not recruiting 51 enrolled Latin American Cooperative Oncology Group Bayer · collab
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2021-06-09
Primary completion
2024-03-15
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Darolutamide Other / unclassified 1200 mg Oral
Subject Testosterone Cypionate Small molecule 400 mg Intramuscular

Indications

prostate cancer