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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

June 9, 2021

Primary Completion Date

March 15, 2024

Study Completion Date

June 30, 2025

Conditions
Prostate Cancer
Interventions
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.

Trial Locations (6)

41.253-190

Hospital São Rafael - Oncologia D'Or BA, Salvador

70.200-730

Hospital Sírio-Libanês DF, Brasília

90.035-000

HMV - Hospital Moinhos de Vento, Porto Alegre

22.250-905

CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas), Rio de Janeiro

01.308-050

Hospital Sírio-Libanês SP, São Paulo

05.653-000

HIAE - Hospital Israelita Albert Einstein, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Latin American Cooperative Oncology Group

OTHER

NCT04558866 - Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial) | Biotech Hunter | Biotech Hunter