Home › Trials › NCT06120491

Comparing Saruparib to placebo in men with metastatic prostate cancer receiving hormonal treatment

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)

Phase 3 Interventional AstraZeneca · NCT06120491

This study is testing whether a new drug called Saruparib can help men with advanced prostate cancer feel better when combined with hormonal treatments compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1800 (estimated)
Ages18 Years to 130 Years
SexMale
SponsorAstraZeneca Industry-sponsored
Locations410 sites (Chandler, Arizona and 409 other locations)
Trial IDNCT06120491 on ClinicalTrials.gov

What this trial studies

This study aims to demonstrate the superiority of Saruparib (AZD5305) combined with physician's choice of new hormonal agents (NHA) compared to a placebo with NHA in men with metastatic castration-sensitive prostate cancer (mCSPC). Approximately 1800 adult participants will be randomized into two cohorts based on their homologous recombination repair mutation (HRRm) status. Participants will receive their assigned treatment and undergo regular tumor evaluations until disease progression or treatment cessation. An independent data monitoring committee will oversee the safety and tolerability of the treatment.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 and older with histologically confirmed metastatic castration-sensitive prostate adenocarcinoma.

Not a fit: Patients with small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve radiographic progression-free survival for men with metastatic castration-sensitive prostate cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating metastatic prostate cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male ≥ 18 years of age.
* Histologically documented prostate adenocarcinoma 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 tissue lesion that is suitable for repeated assessment with CT and/or MRI.
* Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy 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 tumour tissue sample and blood sample (for ctDNA).
* Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.
* Adequate organ and bone marrow 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 dose 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.

Exclusion Criteria:

* Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no clinical MDS/AML suspicion, no specific screening for MDS/AML (by BM/bone biopsy) is required.
* Participants with any known predisposition to bleeding.
* Any history of persisting (\> 2 weeks) severe cytopenia.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
* History of another primary malignancy, with exceptions.
* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
* Cardiac criteria, including history of arrhythmia and cardiovascular disease.
* Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions.
* Prior treatment within 14 days with blood product support or growth factor support.
* Participants who are unevaluable for both bone and soft tissue progression.

Where this trial is running

Chandler, Arizona and 409 other locations

+360 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Castration-Sensitive Prostate CancerAZD5305SaruparibHRRmnon-HRRmmCSPCProstate Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.