Study on Capivasertib and Abiraterone for Treating Metastatic Hormone-Sensitive Prostate Cancer with PTEN Deficiency

Inclusion Criteria

• Have newly diagnosed hormone-sensitive prostate cancer that has spread and is confirmed by medical tests.
• Agree to provide a tissue sample for testing (not from bone metastases).
• Have a specific genetic marker called PTEN deficiency.
• Have cancer that has spread to at least one bone or soft tissue area, confirmed by scans.
• Be eligible for treatment with abiraterone and steroids.
• Be currently receiving hormone therapy or have had surgical removal of the testicles within the last 93 days.
• Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Be able to swallow pills.
• Complete specific health questionnaires and a pain diary before starting the study.
• Agree to use effective contraception or abstain from sex and not donate sperm during the study.
• Be able to provide informed consent and agree to participate in genetic research.

Exclusion Criteria

• Have had major prostate surgery or radiation therapy aimed at curing prostate cancer.
• Have had major surgery within four weeks before starting the study.
• Have cancer that has spread to the brain or spinal cord unless treated and stable.
• Have a history of lung disease that required steroid treatment.
• Have certain heart conditions, such as abnormal heart rhythms or a history of heart attacks.
• Have uncontrolled diabetes or high blood sugar levels.
• Have low blood cell counts or poor liver or kidney function.
• Have active infections like hepatitis B, hepatitis C, or HIV.
• Have conditions that prevent accurate assessment of cancer progression.
• Have digestive issues that prevent proper absorption of the study drug.
• Have other serious health conditions that could interfere with the study.
• Have a history of another cancer unless treated and inactive for at least two years.
• Have taken certain medications or participated in other clinical trials recently.
• Have allergies to the study drugs or similar medications.
• Be involved in the planning or conduct of the study.
• Be judged by the investigator as unlikely to follow study procedures.