NCT04558866

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Latin American Cooperative Oncology Group · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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) progressing after abiraterone. Extreme androgen therapy will include alternating 56-day cycles of darolutamide 1,200mg/day (two 300 tablets every 12 hours) p.o. for 28 days followed by testosterone cypionate 400 mg i.m. During the treatment period, patients will be followed with chest, abdomen and pelvis CT and bone scan every 8-9 weeks until cycle 4 and every 12 weeks thereafter during the study period. Patients who present with disease progression but are considered to be benefiting from the treatment may continue receiving it, but will be followed by their treating physician according to local guidelines (follow-up period). All patients who stopped treatment will enter follow-up period and survival data will be collected from medical charts. Additionally, QoL questionnaires (BPI-SF, EQ-5D-3L and FACT-P) will be applied every 8-9 weeks until the end of treatment.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Testosterone Cypionate	One administration every 63 cycles until progression or unacceptable toxicity or completion of treatment phase (54 weeks; 6 cycles), whichever comes first.
DRUG	Darolutamide	During 4 weeks, from day 29 to day 56 of each 63-day cycle (+- 3 days) until progression or unacceptable toxicity or completion of treatment phase (54 weeks; 6 cycles), whichever comes first.

Timeline

• Start date: 2021-06-09
• Primary completion: 2024-03-15
• Completion: 2026-06-01
• First posted: 2020-09-22
• Last updated: 2026-02-12

Locations

6 sites across 1 country: Brazil