NCT06952803

Who might be able to join this trial:

• You are male and have been diagnosed with prostate cancer (confirmed by a tissue sample/biopsy).
• You have either newly diagnosed high-risk prostate cancer (cancer that has not spread far, but is considered aggressive) or your cancer has come back after prostate removal surgery (shown by rising PSA levels).
• You are able to provide a stored tumour tissue sample for testing.
• Your tumour tissue has been tested and your BRCA1 or BRCA2 gene mutation status has been confirmed.
• After completing your planned radiation therapy, scans (CT or MRI plus a bone scan) show no signs of cancer spread beyond the pelvis.
• After completing your planned radiation therapy, a specialised scan called a PSMA-PET scan shows no signs of cancer spread beyond the pelvis.
• You are generally well enough to carry out light daily activities (with little or no restriction), and this has been stable for at least 2 weeks before joining.
• You are expected to live for at least 12 months.
• Your blood tests show your organs and bone marrow are working well enough (as defined by the trial team).
• You have received radiation therapy to the prostate area, either as a first treatment or to treat a recurrence, given with the aim of curing the cancer.
• You have received hormone therapy using a type of medication called a GnRH analogue (a treatment that lowers testosterone levels).
• You agree not to father children or donate sperm during the trial and for 6 months after your last dose of study treatment.
• You agree to use a condom (with spermicide, where available) during the trial and for 6 months after your last dose, during any sexual activity.

Who may not be able to join:

• You have a history of certain blood or bone marrow conditions (MDS or AML), or show signs that suggest these conditions.
• You have a known tendency to bleed easily — for example, active stomach ulcers, a stroke involving bleeding within the last 6 months, or a serious eye condition related to diabetes.
• You have had severely low blood cell counts lasting more than 2 weeks, for any reason.
• You have ongoing nausea or vomiting, a long-term digestive condition, difficulty swallowing tablets, or have had major bowel surgery that could affect how your body absorbs the study medications.
• You have had another type of cancer in the past (some exceptions may apply — confirm with trial site).
• You still have significant side effects (rated moderate or above) from a previous cancer treatment.
• You have certain heart conditions, including a history of irregular heartbeat or other heart or blood vessel problems (confirm with trial site for full details).
• You currently have active, uncontrolled hepatitis B or hepatitis C.
• You currently have active, uncontrolled HIV infection.
• You currently have active tuberculosis.
• You have previously received chemotherapy (such as docetaxel), immunotherapy, or a type of drug called a PARP inhibitor.
• You have received a blood transfusion or treatment to boost blood cell production within the 14 days before joining.
• You are currently taking certain medications that strongly affect how the body processes drugs (CYP3A4 inducers or inhibitors), or herbal supplements, within a set period before joining.
• You are taking certain medications known to affect heart rhythm in a potentially dangerous way.
• You have a known allergy to the study drug (saruparib) or any of its ingredients.

Important: Always verify eligibility with the trial site directly before applying.