Abiraterone + Prednisone for Prostate Cancer
(APRE Trial)
Trial Summary
What is the purpose of this trial?
The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.
Will I have to stop taking my current medications?
The trial does not require a washout period for antiandrogens or five alpha reductase inhibitors, so you may not need to stop these medications. However, you cannot take ketoconazole, aminoglutethimide, or enzalutamide during the trial.
What data supports the effectiveness of the drug Abiraterone Acetate plus Prednisone for prostate cancer?
Is Abiraterone + Prednisone safe for humans?
How is the drug Abiraterone Acetate with Prednisone unique for prostate cancer?
Abiraterone Acetate with Prednisone is unique because it blocks the production of androgens (male hormones) that fuel prostate cancer growth, and is taken orally, making it more convenient than some other treatments. It is particularly effective for patients with metastatic castration-resistant prostate cancer, significantly improving survival and delaying disease progression compared to standard treatments.12469
Research Team
Martha Mims, MD, PhD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
Men with metastatic hormone naive prostate cancer who have not received certain prior treatments like ketoconazole or chemotherapy for metastasis. They must be over 18, have adequate organ function, and a Zubrod performance status of 0-2 (3 if due to bone pain). Prior surgery is okay after recovery, and they can't have severe heart issues or known brain metastases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abiraterone acetate and prednisone as per standard of care until disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are followed for up to 10 years to assess long-term outcomes
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Martha Mims
Lead Sponsor