Study on the Safety and Effectiveness of Opevesostat for Treating Advanced Prostate Cancer

Inclusion Criteria

• Diagnosed with prostate cancer that has spread and does not respond to hormone therapy.
• Cancer must have progressed despite recent hormone treatments.
• Evidence of cancer spreading to other parts of the body.
• Previously treated with 1 to 2 new hormone therapies for prostate cancer.
• Stable on bone-strengthening treatments for at least 4 weeks.
• Recovered from side effects of previous cancer treatments.
• Well-controlled HIV on medication.
• Hepatitis B positive participants must have undetectable virus levels after treatment.
• Hepatitis C positive participants must have undetectable virus levels.

Exclusion Criteria

• History of pituitary gland problems.
• Poorly controlled diabetes.
• Serious heart or blood vessel problems, including recent heart attack or stroke.
• Family history of long QT syndrome (a heart rhythm condition).
• Blood disorders like myelodysplastic syndrome or leukemia.
• Adrenal gland problems.
• History of lung inflammation requiring steroids.
• HIV with a history of certain cancers.
• Recent major surgery or not fully recovered from surgery.
• Unstable thyroid hormone levels.
• Recent whole blood transfusion.
• Recent cancer treatments or radiation therapy.
• Recent live vaccines.
• Immune system problems or on immunosuppressive therapy.
• Other active cancers needing treatment in the last 3 years.
• Active brain cancer or meningitis.
• Active autoimmune disease needing treatment in the last 2 years.
• Active infection needing treatment.
• Active hepatitis B or C infections.