Study on Apalutamide, Abiraterone Acetate, and Prednisone for Treating Metastatic Castration Resistant Prostate Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT03360721
This clinical trial is exploring how well the combination of apalutamide, abiraterone acetate, and prednisone works in treating prostate cancer that has spread and is resistant to standard hormone therapy. The study aims to see if these medications can better control the cancer by stopping tumor growth and improving bone marrow function.
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Program Overview
This phase II study is testing a combination of medications—apalutamide, abiraterone acetate, and prednisone—to see if they can effectively treat prostate cancer that has spread to other parts of the body and is resistant to standard hormone therapy. Apalutamide and abiraterone acetate work by blocking enzymes that help cancer cells grow, while prednisone helps reduce the immune response and may support bone marrow function. The study will evaluate how well this combination controls cancer progression and its safety for patients.
Description
The main goal of this study is to see how long men with metastatic castration resistant prostate cancer can live without their cancer getting worse when treated with apalutamide, abiraterone acetate, and prednisone. Researchers will also look at the safety of the treatment, overall survival rates, and how the cancer responds to the treatment based on various tests and markers.
Participants will take the medications by mouth daily in 28-day cycles, continuing as long as the treatment is effective and side effects are manageable. After finishing the treatment, participants will be monitored for up to 16 months to track their health and any changes in their cancer.
The study will also explore how certain biomarkers, or biological indicators, relate to treatment outcomes, and will measure changes in prostate-specific antigen (PSA) levels and circulating tumor cells.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of prostate cancer without certain rare features.
- Cancer has spread and can be biopsied.
- Ongoing hormone therapy to lower testosterone levels.
- Low testosterone levels at screening.
- Cancer is progressing based on rising PSA levels, new soft tissue or bone lesions.
- No more than two previous chemotherapy treatments for metastatic prostate cancer.
- Good overall health with an ECOG performance status of 0 or 1.
- Adequate blood and organ function based on specific tests.
- Life expectancy of at least 6 months.
- Ability to swallow pills and follow study requirements.
- Willingness to provide informed consent.
- Tumor sample must meet specific biomarker criteria.
- Agree to use effective birth control methods during and after the study.
Exclusion Criteria
- Allergy to study drugs or their components.
- Severe health conditions that make participation unsafe.
- Cancer spread to the brain.
- Low blood cell counts or organ function at screening.
- Recent history of another cancer with high relapse risk.
- Recent use of certain cancer treatments or radiation.
- Planned procedures for bone pain relief.
- Unstable bone lesions.
- History of seizures or conditions increasing seizure risk.
- Significant heart disease or abnormal heart rhythms.
- Use of medications that lower seizure threshold.
- Prior use of similar medications unless in a specific setting.
- Recent use of investigational drugs.
- Digestive disorders affecting absorption.
- Recent major surgery.
- History of significant bleeding disorders.
- Active viral hepatitis or chronic liver disease.
- History of pituitary or adrenal issues.
- Moderate to severe liver impairment.
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