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.
Hypersensitivity to saruparib, ARPI or any excipients of these products or any contraindication or restriction based on the local label.
Any history of persisting (> 2 weeks) severe cytopenia due to any cause (eg, ANC< 0.5 × 10^9/L or platelets < 50 × 10^9/L)
Any known predisposition to bleeding (eg, active peptic ulceration, recent [within6 months] hemorrhagic stroke, proliferative diabetic retinopathy.
Spinal cord compression or brain metastases unless asymptomatic and stable.