Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
EvoPAR-PR01
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)
2 other identifiers
interventional
1,898
23 countries
316
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Longer than P75 for phase_3
316 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
November 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2031
July 29, 2026
July 1, 2026
3.9 years
October 17, 2023
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiographic Progression-Free Survival (rPFS)
rPFS is defined as the time from randomisation 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.
Up to approximately 50 months
Secondary Outcomes (13)
Overall Survival (OS)
Up to approximately 90 months
Second Progression-Free Survival (PFS2)
Up to approximately 50 months
Time to First Subsequent Therapy or Death (TFST)
Up to approximately 50 months
Symptomatic Skeletal Event-Free Survival (SSE-FS)
Up to approximately 50 months
Time to the First Castration-Resistant Event (TTCR)
Up to approximately 50 months
- +8 more secondary outcomes
Other Outcomes (1)
Number of TEAEs (treatment emergent adverse events), SAEs (serious adverse events), and AEs (adverse events) leading to dose modifications
Up to approximately 50 months
Study Arms (2)
Arm 1: Saruparib (AZD5305) + Physician's Choice NHA
EXPERIMENTALSaruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Arm 2: Placebo + Physician's Choice NHA
PLACEBO COMPARATORPlacebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Interventions
Oral
Oral
Oral
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (322)
Research Site
Chandler, Arizona, 85224, United States
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Gilbert, Arizona, 85234, United States
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Phoenix, Arizona, 85054, United States
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Tucson, Arizona, 85715, United States
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Little Rock, Arkansas, 72205, United States
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Springdale, Arkansas, 72762, United States
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Bakersfield, California, 93301, United States
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Fountain Valley, California, 92708, United States
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Fullerton, California, 92835, United States
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Los Angeles, California, 90073, United States
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Montebello, California, 90640, United States
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San Francisco, California, 94115, United States
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Santa Barbara, California, 93105, United States
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Santa Monica, California, 90404, United States
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Santa Rosa, California, 95403, United States
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Golden, Colorado, 80401, United States
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Lakewood, Colorado, 80228, United States
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New Haven, Connecticut, 06510, United States
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Atlanta, Georgia, 30318, United States
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Glenview, Illinois, 60026, United States
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Lake Barrington, Illinois, 60010, United States
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Fort Wayne, Indiana, 46804, United States
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Indianapolis, Indiana, 46202, United States
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Westwood, Kansas, 66205, United States
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Shreveport, Louisiana, 71103, United States
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Scarborough, Maine, 04074, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21287, United States
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Bethesda, Maryland, 20817, United States
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Towson, Maryland, 21204, United States
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Upper Marlboro, Maryland, 20774, United States
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Grand Rapids, Michigan, 49503, United States
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Troy, Michigan, 48084, United States
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Rochester, Minnesota, 55905, United States
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Bozeman, Montana, 59715, United States
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Las Vegas, Nevada, 89102, United States
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Las Vegas, Nevada, 89148, United States
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Camden, New Jersey, 08103, United States
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Albuquerque, New Mexico, 87109, United States
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East Syracuse, New York, 13057, United States
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New Hyde Park, New York, 11042, United States
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New York, New York, 10029, United States
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Syracuse, New York, 13210, United States
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Durham, North Carolina, 27710, United States
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Cincinnati, Ohio, 45212, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44111, United States
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Cleveland, Ohio, 44124, United States
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Columbus, Ohio, 43210, United States
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Portland, Oregon, 97227, United States
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Bala-Cynwyd, Pennsylvania, 19004-1017, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Providence, Rhode Island, 02903, United States
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Myrtle Beach, South Carolina, 29572, United States
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North Charleston, South Carolina, 29406, United States
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Sioux Falls, South Dakota, 57105, United States
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Germantown, Tennessee, 38138, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77025, United States
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San Antonio, Texas, 78229, United States
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Sugar Land, Texas, 77479, United States
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Tyler, Texas, 75702, United States
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Wichita Falls, Texas, 76310, United States
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Salt Lake City, Utah, 84106, United States
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Salt Lake City, Utah, 84132, United States
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St. George, Utah, 84790, United States
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Fairfax, Virginia, 22031, United States
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Spokane, Washington, 99202, United States
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Tacoma, Washington, 98405, United States
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Chermside, 4032, Australia
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Darlinghurst, 2010, Australia
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Hyde Park, 4812, Australia
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Kurralta Park, 5037, Australia
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Melbourne, 3000, Australia
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South Brisbane, 4101, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Krems, 3500, Austria
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Linz, 4020, Austria
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Vienna, 1020, Austria
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Vienna, 1090, Austria
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Curitiba, 80810-050, Brazil
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Pelotas, 96020-080, Brazil
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Porto Alegre, 90035-001, Brazil
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Rio de Janeiro, 22775-001, Brazil
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Salvador, 41950-640, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01323-903, Brazil
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São Paulo, 05652000, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Calgary, Alberta, T2V 1P9, Canada
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Abbotsford British Columbia, British Columbia, V2S 2J4, Canada
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Abbotsford British Columbia, British Columbia, V2T 1X8, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Vancouver, British Columbia, V5Z 1H7, Canada
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Kingston, Ontario, K7L 5P9, Canada
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Mississauga, Ontario, L5M 2N1, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Concepción, 4070196, Chile
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La Serena, 1720430, Chile
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Santiago, 7500787, Chile
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Santiago, 7520349, Chile
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Santiago, 8241479, Chile
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Santiago, 8330032, Chile
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Temuco, 4781156, Chile
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Viña del Mar, 2540488, Chile
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Beijing, 100021, China
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Beijing, 100034, China
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Beijing, 100050, China
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Beijing, 100142, China
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Beijing, CN-100730, China
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Chongqing, 400038, China
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Dongguan, 523009, China
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Guangzhou, 510180, China
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Guilin, 541000, China
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Hangzhou, 310009, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Jiaxing, 314001, China
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Jinan, 250021, China
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Lanzhou, 730030, China
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Nanchang, 330000, China
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Nanchang, 330029, China
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Nanjing, 2100008, China
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Nantong, 226361, China
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Ningbo, 315010, China
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Shandong, China
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Shanghai, 200002, China
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Shanghai, 200080, China
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Shenyang, 110001, China
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Shenyang, 110004, China
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Suining, 629000, China
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Taiyuan, 030000, China
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Tianjin, 300211, China
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Wenzhou, 325000, China
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Wuhan, 430079, China
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Xi'an, 710061, China
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Yantai, 264000, China
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Zhengzhou, 450008, China
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Angers, 49055, France
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Bayonne, 64109, France
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Bordeaux, 33000, France
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Caen, 41076, France
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Clermont-Ferrand, 63011, France
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Créteil, 94000, France
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Lyon, 69373, France
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Montpellier, 34298, France
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Nice, 06100, France
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Nîmes, 30029, France
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Paris, 75679, France
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Pierre-Bénite, 69495, France
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Poitiers, 86021, France
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Quimper, 29107, France
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Rennes, 35033, France
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Strasbourg, 67200, France
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Tours, 37000, France
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Vandœuvre-lès-Nancy, 54519, France
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Bergisch Gladbach, 51465, Germany
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Berlin, 10117, Germany
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Braunschweig, 38126, Germany
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Cologne, 50968, Germany
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Dresden, 01307, Germany
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Duisburg, 47169, Germany
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Frankfurt, 60488, Germany
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Frankfurt am Main, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20246, Germany
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Heidelberg, 69120, Germany
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Herne, 44625, Germany
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Homburg, 66421, Germany
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Mannheim, 68167, Germany
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Marburg, 35043, Germany
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Mettmann, 40822, Germany
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München, 81675, Germany
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Münster, 48149, Germany
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Nürtingen, 72622, Germany
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Regensburg, 93053, Germany
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Trier, 54292, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4032, Hungary
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Miskolc, 3526, Hungary
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Szeged, 6725, Hungary
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Bangalore, 560027, India
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Calicut, 673601, India
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Kanpur, 208005, India
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Kolkata, 700099, India
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Nagpur, 440001, India
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New Delhi, 110085, India
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New Delhi, 11029, India
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Pune, 411004, India
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Vadodara, 391760, India
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Varanasi, 221005, India
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Bari, 70124, Italy
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Genoa, 16132, Italy
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Meldola, 47014, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Rome, 00168, Italy
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Rozzano, 20089, Italy
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Terni, 05100, Italy
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Trento, 38100, Italy
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Chiba, 260-8717, Japan
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Fukuoka, 811-1347, Japan
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Fukuoka, 812-8582, Japan
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Hirakata-shi, 573-1191, Japan
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Hirosaki-shi, 036-8563, Japan
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Kanazawa, 920-8641, Japan
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Kashihara-shi, 634-8522, Japan
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Kawagoe-shi, 350-8550, Japan
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Kisarazu-shi, 292-8535, Japan
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Kita-gun, 761-0793, Japan
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Kobe, 650-0047, Japan
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Kumamoto, 860-0008, Japan
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Kyoto, 606-8507, Japan
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Maebashi, 371-8811, Japan
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Nagano, 381-8551, Japan
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Nagasaki, 852-8501, Japan
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Nagoya, 466-8560, Japan
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Nagoya, 466-8650, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Sagamihara-shi, 252-0375, Japan
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Sakura-shi, 285-8741, Japan
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Sapporo, 060-8638, Japan
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Shiwa-gun, 028-3695, Japan
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Suita-shi, 565-0871, Japan
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Tsu, 514-8507, Japan
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Yokohama, 232-0024, Japan
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Yufu-shi, 879-5593, Japan
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George Town, 10450, Malaysia
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Johor Bahru, 81100, Malaysia
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Kota Kinabalu, 88996, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuching, 93586, Malaysia
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Amsterdam, 1066 CX, Netherlands
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Hilversum, 1213 XZ, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Bellavista, CALLAO 2, Peru
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Lima, 15036, Peru
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Lima, 15082, Peru
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Lima, 15102, Peru
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Lima, 34, Peru
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Lima, LIMA 29, Peru
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Bydgoszcz, 85-796, Poland
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Koszalin, 75-581, Poland
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Poznan, 61-731, Poland
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Rzeszów, 35-001, Poland
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Warsaw, 04-073, Poland
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Wroclaw, 53-329, Poland
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Daejeon, 35015, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Suwon, 16247, South Korea
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Barcelona, 08035, Spain
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Córdoba, 14004, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Lugo, 27003, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Sabadell, 08208, Spain
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Valencia, 46014, Spain
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 833, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 43503, Taiwan
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Taoyuan, 333, Taiwan
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Yung Kang City, 71044, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Khlong Luang, 12120, Thailand
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Songkhla, 90110, Thailand
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Ankara, 06340, Turkey (Türkiye)
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Ankara, 06590, Turkey (Türkiye)
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Bornova-Izmir, 35100, Turkey (Türkiye)
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Cordaleo, 35575, Turkey (Türkiye)
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Fatih-Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Aberdeen, AB25 2ZN, United Kingdom
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Birmingham, B15 2GW, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Guildford, GU2 7XX, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, W6 8RF, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Newcastle upon Tyne, NE7 7AF, United Kingdom
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Oxford, OX3 7LE, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Truro, TR1 3LJ, United Kingdom
Related Publications (1)
Azad AA, Agarwal N, Armstrong AJ, Hellmis E, Sugimoto M, Urun Y, Xing N, Aregay M, Lima J, Meulendijks D, Chi KN. Saruparib in combination with androgen receptor pathway inhibitors in metastatic hormone-sensitive prostate cancer: EvoPAR-Prostate01. Future Oncol. 2026 Apr;22(10):1153-1163. doi: 10.1080/14796694.2026.2655433. Epub 2026 Apr 14.
PMID: 41979035DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kim Nguyen Chi, MD
BC Cancer, Canada
- PRINCIPAL INVESTIGATOR
Arun Azad, MD
Peter MacCallum Cancer Centre, Australia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2023
First Posted
November 7, 2023
Study Start
November 21, 2023
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
April 30, 2031
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.