Abiraterone + Prednisone for Prostate Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.
Research Team
Janssen Services, LLC. Clinical Trial
Principal Investigator
Janssen Biotech, Inc.
Eligibility Criteria
Men over 18 with prostate cancer, currently on GnRH therapy or who've had testicular surgery, can join. They need a rising PSA level and must be able to swallow pills. Excluded are those with recent antiandrogen therapy, active hepatitis/liver disease, other cancers (except certain skin cancers), heart issues, uncontrolled diabetes/hypertension, or prior treatments affecting CYP17 enzyme.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Core Study Treatment
Participants receive abiraterone acetate plus prednisone for six 28-day cycles
Pre-metastatic Disease Follow-up
Participants are monitored for disease progression without radiographic evidence of metastasis
Optional Drug Holiday
Participants may discontinue treatment and resume if PSA rises without metastasis
Safety Follow-up
Participants return for a safety follow-up visit 30 days after the last dose
Treatment Details
Interventions
- Abiraterone Acetate
- Prednisone
Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer
- Metastatic high-risk castration-sensitive prostate cancer
- Metastatic castration-resistant prostate cancer
- Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer
- Metastatic castration-resistant prostate cancer
- Metastatic castration-sensitive prostate cancer
- Prostate cancer
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Who Is Running the Clinical Trial?
Janssen Biotech, Inc.
Lead Sponsor