Study on Saruparib with Doctor's Choice of ARPI for Men with Metastatic Hormone-Sensitive Prostate Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of prostate cancer that is either new or has come back and is sensitive to hormone treatment.
• Cancer has spread and was confirmed before starting previous treatments with docetaxel or Lu-PSMA.
• Previously treated with docetaxel or Lu-PSMA within the last 6 months.
• Currently receiving hormone therapy or has had surgery to remove testicles.
• No signs of cancer progression.
• Side effects from previous treatments have resolved, except for hair loss and nerve damage.
• PSA level of 0.2 ng/mL or higher within 14 days before starting the study.
• Low testosterone levels.
• Any radiation therapy for symptom management must be completed at least 2-4 weeks before starting the study.
• Provide a tumor tissue sample and blood sample.
• Confirmed genetic status related to cancer.
• Good organ and bone marrow function.
• Expected to live at least 6 more months.
• Male at birth, inclusive of all gender identities.
• Use contraception as per local guidelines.
• Able to give informed consent.

Exclusion Criteria

• Allergic to saruparib, ARPI, or any ingredients in these drugs.
• History of severe low blood cell counts lasting more than 2 weeks.
• Known bleeding disorders or recent serious bleeding events.
• Spinal cord or brain cancer unless stable and not causing symptoms.
• History of certain blood disorders or signs of these disorders.
• History of another cancer, with some exceptions.
• Chronic digestive issues that affect drug absorption.
• History of seizures or conditions that increase seizure risk.
• Serious, uncontrolled medical conditions or infections.
• Major surgery or serious injury within 4 weeks before starting the study.
• Changed ARPI treatment due to cancer progression. If changed for other reasons before joining the study, participation is allowed.
• Previous treatment with PARPi or platinum chemotherapy.