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)

The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.

• : * 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…

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.