Brief Summary
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
Intervention / Treatment
- Drug: Saruparib
- Drug: Placebo
- Drug: Abiraterone Acetate
- Drug: Darolutamide
- Drug: Enzalutamide
Inclusion Criteria:
- Male ≥ 18 years of age.
- Histologically documented prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation adenocarcinomacancer arising from mucus-producing glands in organs which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
- Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissuetissue/the material that joins, holds up or surrounds inside body parts such as fat, muscle, ligaments and lining around joints lesion that is suitable for repeated assessment with CT and/or MRI.
- Participant is receiving ADT with a GnRH analogue or has undergone bilateralaffecting both sides orchiectomyremoval of one or both testicles, also known as orchidectomy starting ≥ 14 days and < 4 months prior to randomisation.
- ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
- Provision of FFPE tumoura tissue mass that forms from groups of unhealthy cells tissuea group of cells that work together to perform a function sample and bloodthe red bodily fluid that transports oxygen and other nutrients around the body sample (for ctDNA).
- Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.
- Adequate organ and bone marrowsoft, spongy tissue found in bones that makes blood cells function as described in study protocol.
- Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dosethe amount of medication taken of study intervention.
- Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.