Study of Capivasertib and Docetaxel vs Placebo and Docetaxel for Treating Advanced Prostate Cancer

Inclusion Criteria

• Diagnosed with prostate cancer that has spread and is resistant to hormone therapy.
• Cancer must be confirmed by lab tests and have spread to bones or soft tissues.
• Previously treated with certain hormone therapies for at least 3 months, with evidence of cancer progression.
• Low testosterone levels (≤ 50 ng/dL).
• Suitable for treatment with docetaxel and steroids.
• Continuing hormone therapy with specific medications or surgery.
• Good overall health with a performance status of 0 or 1 and expected to live at least 12 more weeks.
• Able to provide a tumor sample for testing.
• Able to swallow pills.
• Agree to use contraception or abstain from sex and not donate sperm during the study.

Exclusion Criteria

• Recent wide-field radiation therapy or major surgery within 4 weeks before starting the study.
• Brain or spinal cord cancer spread unless stable and not needing steroids for 4 weeks.
• Heart conditions that could affect safety, such as abnormal heart rhythms or recent heart attacks.
• Uncontrolled diabetes or high blood sugar levels.
• Poor bone marrow or organ function based on specific blood test results.
• Other serious health conditions that could interfere with the study.
• Digestive issues that affect medication absorption.
• Previous bone marrow or organ transplants.
• Other cancers within the last 2 years, except for certain skin cancers or in situ cancers.
• Ongoing side effects from previous cancer treatments, except for hair loss.
• Active hepatitis or HIV infections.
• Active tuberculosis infection.
• Previous chemotherapy for advanced prostate cancer unless completed over 6 months ago.
• Previous treatment with certain cancer drugs or participation in another clinical trial recently.
• Use of medications that affect the heart's electrical activity or certain other medications recently.
• Allergies to study drugs or similar medications.