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OncoMatch/Clinical Trials/NCT06120491

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

Is NCT06120491 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Saruparib and Abiraterone Acetate for metastatic castration-sensitive prostate cancer.

Phase 3RecruitingAstraZenecaNCT06120491Data as of May 2026

Treatment: Saruparib · Abiraterone Acetate · Darolutamide · EnzalutamideThe 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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: androgen deprivation therapy (GnRH analogue) — castration-sensitive

Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting  14 days and < 4 months prior to randomisation.

Must have received: orchiectomy — castration-sensitive

Participant...has undergone bilateral orchiectomy starting  14 days and < 4 months prior to randomisation.

Cannot have received: anticancer pharmacotherapy or surgery for metastatic prostate cancer

Exception: exceptions

Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions.

Cannot have received: blood product support or growth factor support

Prior treatment within 14 days with blood product support or growth factor support.

Lab requirements

Blood counts

Adequate organ and bone marrow function as described in study protocol.

Kidney function

Adequate organ and bone marrow function as described in study protocol.

Liver function

Adequate organ and bone marrow function as described in study protocol.

Cardiac function

Cardiac criteria, including history of arrhythmia and cardiovascular disease [excluded].

Adequate organ and bone marrow function as described in study protocol.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Research Site · Chandler, Arizona
  • Research Site · Gilbert, Arizona
  • Research Site · Phoenix, Arizona
  • Research Site · Tucson, Arizona
  • Research Site · Little Rock, Arkansas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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