Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)

Critères d'inclusion

• Participant must be ≥ 18 at the time of signing the informed consent. • Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive. • Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or Lu-PSMA-containing regimens for mHSPC. • Previous treatment with docetaxel (IV, Q3w)- or Lu-PSMA (IV, Q6w) with last dose within past 6 months. • Participants must have the following: • Must be receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy. • Had no evidence of disease progression • Had all toxicities related to docetaxel- or Lu-PSMA-containing treatment (except for alopecia and peripheral neuropathy) resolved to CTCAE Grade 1 or lower. • PSA ≥ 0.2 ng/mL within 14 days prior to randomization. • Serum testosterone \< 1.7 nmol/L or 50 ng/dL. • Palliative radiotherapy for symptoms management will be permitted and is to be completed at least 4 weeks prior to randomization for wide field radiation therapy and at least 2 weeks prior to randomization for limited field radiation therapy. • Provision of a FFPE tumor tissue sample and a blood sample (for ctDNA). • Confirmed HRRm, HRD and PTEN status. • Adequate organ and bone marrow function. • Minimum life expectancy of 6 months. • Male, assigned at birth, inclusive of all gender identities. • Contraceptive use by participants or participant partners should be consistent with local regulations. • Capable of giving signed informed consent. • \- -