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Recruiting Phase 3

Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)

NCT07711002 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2026-09-15
Last updated
2026-10-15

Condition(s) studied

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Investigational drug(s) / intervention(s)

Saruparib →PlaceboEnzalutamide →Darolutamide →Abiraterone →

Saruparib: Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)

Placebo: Arm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)

Enzalutamide: Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

Darolutamide: Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

Abiraterone: Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

Study summary

The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participant must be ≥ 18 at the time of signing the informed consent. * Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive. * Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or Lu-PSMA-containing regimens for mHSPC. * Previous treatment with docetaxel (IV, Q3w)- or Lu-PSMA (IV, Q6w) with last dose within past 6 months. * Participants must have the following: * Must be receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy. * Had no evidence of disease progression * Had all toxicities related to docetaxel- or Lu-PSMA-containing treatment (except for alopecia and peripheral neuropathy) resolved to CTCAE Grade 1 or lower. * PSA ≥ 0.2 ng/mL within 14 days prior to randomization. * Serum testosterone \< 1.7 nmol/L or 50 ng/dL. * Palliative radiotherapy for symptoms management will be permitted and is to be completed at least 4 weeks prior to randomization for wide field radiation therapy and at least 2 weeks prior to randomization for limited field radiation therapy. * Provision of a FFPE tumor tissue sample and a blood sample (for ctDNA). * Confirmed HRRm, HRD and PTEN status. * Adequate organ and bone marrow function. * Minimum life expectancy of 6 months. * Male, assigned at birth, inclusive of all gender identities. * Contraceptive use by participants or participant partners should be consistent with local regulations. * Capable of giving signed informed consent. * \- - Exclusion Criteria: * Hypersensitivity to saruparib, ARPI or any excipients of these products or any contraindication or restriction based on the local label. * Any history of persisting (\> 2 weeks) severe cytopenia due to any cause (eg, ANC\< 0.5 × 10\^9/L or platelets \< 50 × 10\^9/L) * Any known predisposition to bleeding (eg, active peptic ulceration, recent \[within6 months\] hemorrhagic stroke, proliferative diabetic retinopathy. * Spinal cord compression or brain metastases unless asymptomatic and stable. * History of MDS/AML or with features suggestive of MDS/AML * History of another primary malignancy, with some exceptions. * Any chronic gastrointestinal diseases or conditions including inability to swallow the formulated product that would preclude adequate absorption of any study drug. * History of seizure or predispose to seizure, including any history of loss of consciousness or transient ischemic attack within 12 months of enrolment. * Serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. * Major surgical procedure or significant traumatic injury within 4 weeks of the first dose or an anticipated need for major surgery during the study. * Switched ARPI agent in previous treatment for mHSPC due to disease progression. Note: if the ARPI agent was switched due to any reason other than disease progression and switch was prior to ICF signature, participants will be eligible. * Any prior treatment with a PARPi or platinum chemotherapy. * \- -

Primary outcome measure(s)

  • Radiographic progression-free survival (rPFS) — Up to approximately 56 months
    Radiographic PFS (rPFS) is the primary endpoint of this study, defined as the time from randomization to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.

Trial sites (210)

FacilityCityRegionStatus
Research Site Hot Springs Arkansas Not Yet Recruiting
Research Site Springdale Arkansas Recruiting
Research Site Beverly Hills California Not Yet Recruiting
Research Site Los Alamitos California Not Yet Recruiting
Research Site Los Angeles California Not Yet Recruiting
Research Site San Diego California Withdrawn
Research Site Margate Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Orlando Florida Not Yet Recruiting
Research Site Honolulu Hawaii Not Yet Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Elk Grove Village Illinois Not Yet Recruiting
Research Site Hinsdale Illinois Not Yet Recruiting
Research Site Ames Iowa Not Yet Recruiting
Research Site Baltimore Maryland Not Yet Recruiting
Research Site Baltimore Maryland Not Yet Recruiting
Research Site Towson Maryland Not Yet Recruiting
Research Site Detroit Michigan Not Yet Recruiting
Research Site Grand Rapids Michigan Not Yet Recruiting
Research Site Marshall Minnesota Not Yet Recruiting
Research Site Camden New Jersey Not Yet Recruiting
Research Site Albuquerque New Mexico Not Yet Recruiting
Research Site Shirley New York Not Yet Recruiting
Research Site Canton Ohio Not Yet Recruiting
Research Site Cincinnati Ohio Not Yet Recruiting
Research Site Portland Oregon Not Yet Recruiting
Research Site Portland Oregon Not Yet Recruiting
Research Site Greenville South Carolina Not Yet Recruiting
Research Site Aberdeen South Dakota Not Yet Recruiting
Research Site Mitchell South Dakota Not Yet Recruiting
Research Site Pierre South Dakota Not Yet Recruiting
Research Site Sioux Falls South Dakota Not Yet Recruiting
Research Site Yankton South Dakota Not Yet Recruiting
Research Site Nashville Tennessee Not Yet Recruiting
Research Site Austin Texas Not Yet Recruiting
Research Site Dallas Texas Not Yet Recruiting
Research Site Fort Worth Texas Not Yet Recruiting
Research Site Longview Texas Not Yet Recruiting
Research Site Wichita Falls Texas Not Yet Recruiting

+ 170 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07711002 on ClinicalTrials.gov ↗ ← All trials in the UK