A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

• Prostate adenocarcinoma which is de novo or recurrent and castrate sensitive
• No small cell, neuroendocrine, sarcomatoid, spindle cell, or signet ring histology
• Metastatic disease with clear evidence of at least 1 bone lesion and/or at least 1 soft tissue lesion that is assesable via CT or MRI
• Receiving ADT with a GnRH analogue or has had bileteral orchiectomy
• ECOG PS 0-1
• Confirmed HRRm status by central tumor tissue and/or ctDNA test
• No history of another primary malignancy (with some exceptions per protocol)
• No spinal cord compression or brain mets unless asymptomatic and not requiring steroids

• Primary
  • Radiographic PFS
• Secondary
  • OS
  • PFS2
  • Time to first subsequent therapy or death
  • Symptomatic skeletal event-free survival
  • Time to first castration resistant event
  • QOL
  • Safety