A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
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.
Main Inclusion/Exclusion:
- – Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive.
- Metastatic disease as documented by the investigator prior to randomization, with clear evidence of ≥ 1 bone lesion (defined as one lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment with CT and/or MRI.
- Participants with metastatic disease identified by PSMA-PET only, will not be eligible. Participants with disease limited to regional pelvic lymph nodes only are not eligible
- ECOG 0-1
- Any prior treatment with a PARP inhibitor or platinum chemotherapy are excluded
Indications:
- Metastatic castration-Sensitive Prostate Cancer (mCSPC)
Contact: cajwciclinicaltrials@providence.org