EVOPAR

To demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

To demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of overall survival (OS) in participants with mCSPC.

To demonstrate the effectiveness of AZD5305 + physician’s choice NHA relative to placebo +
physician’s choice NHA by assessment of time to the first castration-resistant event (TTCR) in participants with mCSPC.

This is a Phase III, 2-cohort, 2-arm, parallel-group, randomised, double-blind, placebo-controlled, multicentre, global study, assessing the efficacy and safety of AZD5305 + physician’s choice NHA compared with placebo + physician’s choice NHA in
participants with mCSPC with and without HRRm. Randomised participants will continue treatment with AZD5305/placebo in combination with physician’s choice NHA until investigator-assessed disease progression by RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1 (soft tissue lesions)
and/or Prostate Cancer Working Group 3 (PCWG3) (bone lesions), unacceptable toxicity occurs, or the participant withdraws consent.
The study will be conducted using a decentralised model, meaning where possible, if permissible under local regulations, and with participant agreement, participant visits will be performed remotely, and study intervention will be shipped directly to the participant’s home via a solution and services method compliant with Good Clinical Practice/Good Manufacturing Practice/Good Documentation Practice.