Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

September 23, 2014

Primary Completion Date

October 26, 2018

Study Completion Date

October 26, 2018

Conditions
Prostatic Neoplasms
Interventions
DRUG

Abiraterone acetate

Participants will receive abiraterone acetate 1000 mg (4\*250 mg tablets) orally once daily until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.

DRUG

Prednisone

Participants will prednisone 5 mg orally once daily from Day 1 of Cycle 1 and continues until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.

DRUG

Androgen deprivation therapy (ADT)

Participants will remain on a stable regimen of ADT, that is, luteinizing hormone-releasing hormone (LHRH) agonists including leuprolide acetate and goserelin acetate as per Investigator's discretion.

Trial Locations (4)

Unknown

Porto Alegre

Rio de Janeiro

Santo André

São Paulo

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02217566 - Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy | Biotech Hunter | Biotech Hunter