Abiraterone + Prednisone + Apalutamide for Prostate Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate and apalutamide may lessen the amount of androgen made by the body.
Will I have to stop taking my current medications?
The trial requires that medications known to lower the seizure threshold be stopped or replaced at least 4 weeks before starting the study. Additionally, if you are on anti-androgens with LHRH agonists, these must be stopped within 2 weeks before starting the trial.
What data supports the effectiveness of the drug combination Abiraterone, Prednisone, and Apalutamide for prostate cancer?
Research shows that Abiraterone combined with Prednisone improves survival and delays disease progression in men with metastatic prostate cancer, especially when used with androgen deprivation therapy. Although Apalutamide is not directly mentioned in these studies, it is another drug used to treat prostate cancer, suggesting potential benefits when combined with Abiraterone and Prednisone.12345
Is the combination of Abiraterone, Prednisone, and Apalutamide safe for humans?
Abiraterone combined with prednisone is generally safe for treating prostate cancer, but it can sometimes cause liver issues and hormonal imbalances. Patients may experience increased liver enzymes and conditions like mineralocorticoid excess (too much of certain hormones) and adrenal insufficiency (not enough hormone production by the adrenal glands).26789
What makes the drug combination of Abiraterone, Prednisone, and Apalutamide unique for prostate cancer?
This drug combination is unique because it combines Abiraterone and Apalutamide, which both target androgen (male hormone) pathways, with Prednisone, a steroid that helps manage side effects, potentially offering a more comprehensive approach to treating prostate cancer compared to using these drugs separately.136710
Research Team
Paul Corn
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
Men with hormone-naive metastatic prostate cancer who can perform daily activities with some limitations (ECOG <=2) and have certain high-risk factors like a Gleason score >=8. They must not have small cell prostate cancer, heart issues, or conditions increasing bowel perforation risk. Participants need to be able to take oral medication and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abiraterone acetate, prednisone, and apalutamide. Cycles repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abiraterone Acetate
- Apalutamide
- 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?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator