Study on Abiraterone Acetate, Prednisone, and Apalutamide with or without Additional Treatments for Metastatic Castration-Resistant Prostate Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT02703623
This clinical trial is exploring different combinations of medications to treat prostate cancer that has spread and is resistant to hormone therapy. The study aims to find out if adding other treatments like ipilimumab or chemotherapy drugs cabazitaxel and carboplatin can improve outcomes.
Patient Parameters
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Program Overview
This study is testing how well a combination of drugs—abiraterone acetate, prednisone, and apalutamide—works in treating prostate cancer that has spread and is resistant to hormone therapy. Researchers are also looking at whether adding ipilimumab, an immunotherapy drug, or chemotherapy drugs cabazitaxel and carboplatin can help. The goal is to see which combination is most effective in controlling the cancer and improving survival.
Description
The study is divided into different parts based on how patients respond to initial treatment. All participants start with an 8-week phase where they take abiraterone acetate, prednisone, and apalutamide. After this, patients are grouped based on their response:
- Group 2A: Patients continue with the same medications if their cancer markers show a satisfactory decline.
- Group 2B: Patients receive the same medications plus ipilimumab if their cancer markers show a satisfactory decline.
- Group 3: Patients receive the same medications plus chemotherapy drugs cabazitaxel and carboplatin if their cancer markers do not show a satisfactory decline.
The study aims to determine which combination of treatments is most effective in extending survival and controlling the cancer. Researchers will also monitor the side effects of each treatment combination. After completing the study treatment, patients will have follow-up visits to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Male, 18 years or older.
- Diagnosed with prostate cancer that has spread to other parts of the body.
- Cancer must be resistant to hormone therapy, with evidence of progression.
- Must have low testosterone levels due to medical or surgical treatment.
- Good overall health with a performance status of 0 to 2.
- Adequate blood counts and organ function as determined by specific tests.
- Willing to use effective contraception if there is a risk of pregnancy in a partner.
- Able to swallow pills and willing to provide tissue samples for research.
Exclusion Criteria
- Previous treatment with ipilimumab.
- Recent treatment with certain prostate cancer therapies or investigational drugs.
- More than two lines of chemotherapy that the cancer did not respond to.
- Uncontrolled medical conditions, such as infections or heart disease.
- History of other cancers requiring treatment in the past five years.
- Autoimmune diseases or conditions that increase the risk of seizures.
- Gastrointestinal disorders affecting drug absorption.
- Currently incarcerated or detained individuals.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| M D Anderson Cancer Center | 77030 | Houston | Texas |
| MD Anderson in Katy | 77094 | Houston | Texas |
| MD Anderson in Sugar Land | 77478 | Sugar Land | Texas |
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