Metastatic Castration-Sensitive Prostate CancerPhase 3EvoPAR-PR01NCT06120491

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

A Phase 3 study testing Saruparib, Abiraterone Acetate and Darolutamide in people with Metastatic Castration-Sensitive Prostate Cancer, run by AstraZeneca at 322 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 130 years, men only
Conditions the study is for: Metastatic Castration-Sensitive Prostate Cancer
What is being tested?: Saruparib, Abiraterone Acetate and Darolutamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,898 participants
Where: 322 sitesin 24 countries
Study dates: 21 Nov 2023to 30 Apr 2031
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Show all 10Show fewer

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

322 sites in 24 countries.

Country

City, postcode or hospital

322 sites in 24 countries

United States71 sites

Research Site
Albuquerque, New Mexico, 87109
Research Site
Atlanta, Georgia, 30318
Research Site
Bakersfield, California, 93301
Research Site
Bala-Cynwyd, Pennsylvania, 19004-1017
Research Site
Baltimore, Maryland, 21201
Research Site
Baltimore, Maryland, 21287
Research Site
Bethesda, Maryland, 20817
Research Site
Bozeman, Montana, 59715
Research Site
Camden, New Jersey, 08103
Research Site
Chandler, Arizona, 85224
Research Site
Cincinnati, Ohio, 45212
Research Site
Cincinnati, Ohio, 45219
Research Site
Cleveland, Ohio, 44111
Research Site
Cleveland, Ohio, 44124
Research Site
Columbus, Ohio, 43210
Research Site
Dallas, Texas, 75231
Research Site
Durham, North Carolina, 27710
Research Site
East Syracuse, New York, 13057
Research Site
Fairfax, Virginia, 22031
Research Site
Fort Wayne, Indiana, 46804
Research Site
Fountain Valley, California, 92708
Research Site
Fullerton, California, 92835
Research Site
Germantown, Tennessee, 38138
Research Site
Gilbert, Arizona, 85234
Research Site
Glenview, Illinois, 60026
Research Site
Golden, Colorado, 80401
Research Site
Grand Rapids, Michigan, 49503
Research Site
Houston, Texas, 77025
Research Site
Indianapolis, Indiana, 46202
Research Site
Lake Barrington, Illinois, 60010
Research Site
Lakewood, Colorado, 80228
Research Site
Las Vegas, Nevada, 89102
Research Site
Las Vegas, Nevada, 89148
Research Site
Little Rock, Arkansas, 72205
Research Site
Los Angeles, California, 90073
Research Site
Montebello, California, 90640
Research Site
Myrtle Beach, South Carolina, 29572
Research Site
Nashville, Tennessee, 37203
Research Site
New Haven, Connecticut, 06510
Research Site
New Hyde Park, New York, 11042
Research Site
New York, New York, 10029
Research Site
North Charleston, South Carolina, 29406
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Phoenix, Arizona, 85054
Research Site
Pittsburgh, Pennsylvania, 15212
Research Site
Portland, Oregon, 97227
Research Site
Providence, Rhode Island, 02903
Research Site
Rochester, Minnesota, 55905
Research Site
Salt Lake City, Utah, 84106
Research Site
Salt Lake City, Utah, 84132
Research Site
San Antonio, Texas, 78229
Research Site
San Francisco, California, 94115
Research Site
Santa Barbara, California, 93105
Research Site
Santa Monica, California, 90404
Research Site
Santa Rosa, California, 95403
Research Site
Scarborough, Maine, 04074
Research Site
Shreveport, Louisiana, 71103
Research Site
Sioux Falls, South Dakota, 57105
Research Site
Spokane, Washington, 99202
Research Site
Springdale, Arkansas, 72762
Research Site
St. George, Utah, 84790
Research Site
Sugar Land, Texas, 77479
Research Site
Syracuse, New York, 13210
Research Site
Tacoma, Washington, 98405
Research Site
Towson, Maryland, 21204
Research Site
Troy, Michigan, 48084
Research Site
Tucson, Arizona, 85715
Research Site
Tyler, Texas, 75702
Research Site
Upper Marlboro, Maryland, 20774
Research Site
Westwood, Kansas, 66205
Research Site
Wichita Falls, Texas, 76310

Other trials in United States

China37 sites

Research Site
Beijing, 100021
Research Site
Beijing, 100034
Research Site
Beijing, 100050
Research Site
Beijing, 100142
Research Site
Beijing, CN-100730
Research Site
Changchun, 130021
Research Site
Changsha, 410013
Research Site
Chengdu, 610041
Research Site
Chongqing, 400030
Research Site
Chongqing, 400038
Research Site
Dongguan, 523009
Research Site
Guangzhou, 510180
Research Site
Guilin, 541000
Research Site
Hangzhou, 310009
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Jiaxing, 314001
Research Site
Jinan, 250021
Research Site
Lanzhou, 730030
Research Site
Nanchang, 330000
Research Site
Nanchang, 330029
Research Site
Nanjing, 2100008
Research Site
Nantong, 226361
Research Site
Ningbo, 315010
Research Site
Shandong
Research Site
Shanghai, 200002
Research Site
Shanghai, 200080
Research Site
Shenyang, 110001
Research Site
Shenyang, 110004
Research Site
Suining, 629000
Research Site
Taiyuan, 030000
Research Site
Tianjin, 300211
Research Site
Wenzhou, 325000
Research Site
Wuhan, 430079
Research Site
Xi'an, 710061
Research Site
Yantai, 264000
Research Site
Zhengzhou, 450008

Other trials in China

Japan28 sites

Research Site
Chiba, 260-8717
Research Site
Fukuoka, 811-1347
Research Site
Fukuoka, 812-8582
Research Site
Hirakata-shi, 573-1191
Research Site
Hirosaki-shi, 036-8563
Research Site
Kanazawa, 920-8641
Research Site
Kashihara-shi, 634-8522
Research Site
Kawagoe-shi, 350-8550
Research Site
Kisarazu-shi, 292-8535
Research Site
Kita-gun, 761-0793
Research Site
Kobe, 650-0047
Research Site
Kumamoto, 860-0008
Research Site
Kyoto, 606-8507
Research Site
Maebashi, 371-8811
Research Site
Nagano, 381-8551
Research Site
Nagasaki, 852-8501
Research Site
Nagoya, 466-8560
Research Site
Nagoya, 466-8650
Research Site
Osaka, 541-8567
Research Site
Osakasayama-shi, 589-8511
Research Site
Sagamihara-shi, 252-0375
Research Site
Sakura-shi, 285-8741
Research Site
Sapporo, 060-8638
Research Site
Shiwa-gun, 028-3695
Research Site
Suita-shi, 565-0871
Research Site
Tsu, 514-8507
Research Site
Yokohama, 232-0024
Research Site
Yufu-shi, 879-5593

Other trials in Japan

Germany23 sites

Research Site
Bergisch Gladbach, 51465
Research Site
Berlin, 10117
Research Site
Braunschweig, 38126
Research Site
Cologne, 50968
Research Site
Dresden, 01307
Research Site
Duisburg, 47169
Research Site
Frankfurt, 60488
Research Site
Frankfurt am Main, 60590
Research Site
Freiburg im Breisgau, 79106
Research Site
Hamburg, 20246
Research Site
Heidelberg, 69120
Research Site
Herne, 44625
Research Site
Homburg, 66421
Research Site
Mannheim, 68167
Research Site
Marburg, 35043
Research Site
Mettmann, 40822
Research Site
München, 81675
Research Site
Münster, 48149
Research Site
Nürtingen, 72622
Research Site
Regensburg, 93053
Research Site
Trier, 54292
Research Site
Tübingen, 72076
Research Site
Ulm, 89081

Other trials in Germany

Canada19 sites

Research Site
Abbotsford British Columbia, British Columbia, V2S 2J4
Research Site
Abbotsford British Columbia, British Columbia, V2T 1X8
Research Site
Calgary, Alberta, T2N 5G2
Research Site
Calgary, Alberta, T2V 1P9
Research Site
Chicoutimi, Quebec, G7H 5H6
Research Site
Greenfield Park, Quebec, J4V 2H1
Research Site
Kelowna, British Columbia, V1Y 5L3
Research Site
Kingston, Ontario, K7L 5P9
Research Site
Mississauga, Ontario, L5M 2N1
Research Site
Montreal, Quebec, H2X 3E4
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Newmarket, Ontario, L3Y 2P9
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Québec, Quebec, G1J 1Z4
Research Site
Saskatoon, Saskatchewan, S7N 4H4
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 2M9
Research Site
Vancouver, British Columbia, V5Z 1H7

Other trials in Canada

France18 sites

Research Site
Angers, 49055
Research Site
Bayonne, 64109
Research Site
Bordeaux, 33000
Research Site
Caen, 41076
Research Site
Clermont-Ferrand, 63011
Research Site
Créteil, 94000
Research Site
Lyon, 69373
Research Site
Montpellier, 34298
Research Site
Nice, 06100
Research Site
Nîmes, 30029
Research Site
Paris, 75679
Research Site
Pierre-Bénite, 69495
Research Site
Poitiers, 86021
Research Site
Quimper, 29107
Research Site
Rennes, 35033
Research Site
Strasbourg, 67200
Research Site
Tours, 37000
Research Site
Vandœuvre-lès-Nancy, 54519

Other trials in France

United Kingdom13 sites

Research Site
Aberdeen, AB25 2ZN
Research Site
Birmingham, B15 2GW
Research Site
Cambridge, CB2 0QQ
Research Site
Glasgow, G12 0YN
Research Site
Guildford, GU2 7XX
Research Site
London, EC1A 7BE
Research Site
London, W6 8RF
Research Site
Manchester, M20 4BX
Research Site
Newcastle upon Tyne, NE7 7AF
Research Site
Oxford, OX3 7LE
Research Site
Plymouth, PL6 8DH
Research Site
Preston, PR2 9HT
Research Site
Truro, TR1 3LJ

Other trials in United Kingdom

Italy11 sites

Research Site
Bari, 70124
Research Site
Genoa, 16132
Research Site
Meldola, 47014
Research Site
Milan, 20132
Research Site
Milan, 20133
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Rome, 00168
Research Site
Rozzano, 20089
Research Site
Terni, 05100
Research Site
Trento, 38100

Other trials in Italy

India10 sites

Research Site
Bangalore, 560027
Research Site
Calicut, 673601
Research Site
Kanpur, 208005
Research Site
Kolkata, 700099
Research Site
Nagpur, 440001
Research Site
New Delhi, 110085
Research Site
New Delhi, 11029
Research Site
Pune, 411004
Research Site
Vadodara, 391760
Research Site
Varanasi, 221005

Other trials in India

Spain9 sites

Research Site
Barcelona, 08035
Research Site
Córdoba, 14004
Research Site
L'Hospitalet de Llobregat, 08908
Research Site
Lugo, 27003
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Sabadell, 08208
Research Site
Valencia, 46014

Other trials in Spain

Brazil8 sites

Research Site
Curitiba, 80810-050
Research Site
Pelotas, 96020-080
Research Site
Porto Alegre, 90035-001
Research Site
Rio de Janeiro, 22775-001
Research Site
Salvador, 41950-640
Research Site
São Paulo, 01246-000
Research Site
São Paulo, 01323-903
Research Site
São Paulo, 05652000

Other trials in Brazil

Chile8 sites

Research Site
Concepción, 4070196
Research Site
La Serena, 1720430
Research Site
Santiago, 7500787
Research Site
Santiago, 7520349
Research Site
Santiago, 8241479
Research Site
Santiago, 8330032
Research Site
Temuco, 4781156
Research Site
Viña del Mar, 2540488

Other trials in Chile

South Korea8 sites

Research Site
Daejeon, 35015
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Research Site
Suwon, 16247

Other trials in South Korea

Australia6 sites

Research Site
Chermside, 4032
Research Site
Darlinghurst, 2010
Research Site
Hyde Park, 4812
Research Site
Kurralta Park, 5037
Research Site
Melbourne, 3000
Research Site
South Brisbane, 4101

Other trials in Australia

Austria6 sites

Research Site
Graz, 8036
Research Site
Innsbruck, 6020
Research Site
Krems, 3500
Research Site
Linz, 4020
Research Site
Vienna, 1020
Research Site
Vienna, 1090

Other trials in Austria

Malaysia6 sites

Research Site
George Town, 10450
Research Site
Johor Bahru, 81100
Research Site
Kota Kinabalu, 88996
Research Site
Kuala Lumpur, 50586
Research Site
Kuala Lumpur, 59100
Research Site
Kuching, 93586

Other trials in Malaysia

Peru6 sites

Research Site
Bellavista, CALLAO 2
Research Site
Lima, 15036
Research Site
Lima, 15082
Research Site
Lima, 15102
Research Site
Lima, 34
Research Site
Lima, LIMA 29

Other trials in Peru

Poland6 sites

Research Site
Bydgoszcz, 85-796
Research Site
Koszalin, 75-581
Research Site
Poznan, 61-731
Research Site
Rzeszów, 35-001
Research Site
Warsaw, 04-073
Research Site
Wroclaw, 53-329

Other trials in Poland

Taiwan6 sites

Research Site
Kaohsiung City, 80756
Research Site
Kaohsiung City, 833
Research Site
Taichung, 40447
Research Site
Taichung, 43503
Research Site
Taoyuan, 333
Research Site
Yung Kang City, 71044

Other trials in Taiwan

Thailand6 sites

Research Site
Bangkok, 10210
Research Site
Bangkok, 10330
Research Site
Bangkok, 10700
Research Site
Chiang Mai, 50200
Research Site
Khlong Luang, 12120
Research Site
Songkhla, 90110

Other trials in Thailand

Turkey (Türkiye)6 sites

Research Site
Ankara, 06340
Research Site
Ankara, 06590
Research Site
Bornova-Izmir, 35100
Research Site
Cordaleo, 35575
Research Site
Fatih-Istanbul, 34098
Research Site
Istanbul, 34722

Other trials in Turkey (Türkiye)

Hungary5 sites

Research Site
Budapest, 1122
Research Site
Budapest, 1145
Research Site
Debrecen, 4032
Research Site
Miskolc, 3526
Research Site
Szeged, 6725

Other trials in Hungary

Belgium3 sites

Research Site
Ghent, 9000
Research Site
Kortrijk, 8500
Research Site
Leuven, 3000

Other trials in Belgium

Netherlands3 sites

Research Site
Amsterdam, 1066 CX
Research Site
Hilversum, 1213 XZ
Research Site
Nijmegen, 6525 GA

Other trials in Netherlands

About this study

Official title: 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)

Read the detailed description

Approximately 1800 adult participants with mCSPC will be assigned to one of two cohorts (550 HRRm and 1250 non-HRRm) and randomized in a 1:1 ratio to receive either Saruparib (AZD5305) with NHA or placebo with NHA. They will receive their assigned treatment and regular tumor evaluation scans until disease progression, or until treatment is stopped for another reason.

All patients will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of Saruparib (AZD5305) + physicians choice NHA.

Conditions: Metastatic Castration-Sensitive Prostate Cancer
Being tested: Saruparib, Placebo, Abiraterone Acetate, Darolutamide, Enzalutamide
Keywords: AZD5305; Saruparib; HRRm; non-HRRm; mCSPC; Prostate Cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SaruparibDrug
Also called AZD5305
Oral
PlaceboDrug
Oral
Abiraterone AcetateDrug
Also called Zytiga
Oral
DarolutamideDrug
Also called Nubeqa
Oral
EnzalutamideDrug
Also called Xtandi
Oral

Study groups in NCT06120491
Study group	Role	What they receive
Arm 1: Saruparib (AZD5305) + Physician's Choice NHA	Experimental	Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide) Receives: Drug: Saruparib; Drug: Abiraterone Acetate; Drug: Darolutamide; Drug: Enzalutamide
Arm 2: Placebo + Physician's Choice NHA	Placebo comparator	Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide) Receives: Drug: Placebo; Drug: Abiraterone Acetate; Drug: Darolutamide; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to approximately 50 months

Secondary outcomes (13)

Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: Up to approximately 90 months
Second Progression-Free Survival (PFS2)
Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression (defined as radiographic progression, clinical progression, or PSA progression) after initiation of first subsequent treatment following the initial investigator-assessed progression or death.
Measured: Up to approximately 50 months
Time to First Subsequent Therapy or Death (TFST)
TFST is defined as the time from randomisation to the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause.
Measured: Up to approximately 50 months
Symptomatic Skeletal Event-Free Survival (SSE-FS)
SSE-FS is defined as the time from randomisation to the earliest of the following:
- Use of radiation therapy to prevent or relieve skeletal symptoms.
- Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).
- Occurrence of spinal cord compression.
- Orthopaedic surgical intervention for bone metastasis.
- Death due to any cause.
Measured: Up to approximately 50 months
Time to the First Castration-Resistant Event (TTCR)
TTCR is defined as the time from randomisation to the first castration resistant event (radiographic disease progression per RECIST 1.1 [soft tissue] and/or PCWG3 criteria [bone], PSA progression per PCWG3, or SSE, PSA progression per PCWG3, or SSE), whichever occurs first, with castrate levels of testosterone (below 50 ng/dL).
Measured: Up to approximately 50 months
Time to Pain Progression (TTPP)
TTPP is defined as the time from randomisation to clinically meaningful pain progression based on a 2-point increase from baseline in the Brief Pain Inventory - Short Form (BPI-SF) Item 3 'worst pain in 24 hours' score and/or initiation of/increase in opioid analgesic use.
Measured: Up to approximately 50 months
Time To Deterioration in Urinary Symptoms (TTDUS)
TTDUS is defined as the time from randomisation to deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Prostate Questionnaire (Urinary Symptoms) (QLQPR25 [US]) subscale scores.
Measured: Up to approximately 50 months
Time to Deterioration in Physical Function (TTDPF)
TTDPF is defined as the time from randomisation to deterioration in PROMIS Physical Function Short Form 8C scores, or death due to any cause.
Measured: Up to approximately 50 months
Health-related Quality of Life (HrQoL)
Change from baseline in BPI-SF worst pain score, pain severity, and interference domain scores.
Measured: Up to approximately 50 months
BRCA, other HRR gene mutation and HRD status
Measured: At screening
Plasma concentrations of AZD5305
Measured: Up to approximately 10 months
Samples will be used to develop complementary or companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
Samples will be tested by a CDx to certify consistency with assays used in the study.
Measured: Up to approximately 50 months
Assessment of PSA (prostate-specific antigen) in participants in mCSPC
proportion of participants achieving a >= 50% or >=90% decrease in PSA from baseline; proportion of participants with undetectable PSA (< 0.2 ng/mL); time to PSA progression
Measured: Up to approximately 50 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 202330 Apr 2031

First posted7 Nov 2023
Study start21 Nov 2023
Primary completion30 Sep 2027 (estimated)
Study completion30 Apr 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metastatic Castration-Sensitive Prostate CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Within each cohort (HRRm and non-HRRm), participants are randomised in 1:1 ratio to one of two treatment arms
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,898 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06120491
Sponsor's protocol ID: D9723C00001
Other IDs: 2023-504214-30-00, 2023
Acronym: EvoPAR-PR01
Status last verified: Jul 2026
First submitted: 17 Oct 2023
Last updated: 29 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 41979035

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer
Not yet recruitingPhase 1/2
RYZ711 Diagnostic Platform Study
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RecruitingObservational study
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
RecruitingPhase 2
Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma
RecruitingPhase 1
JUR-003 in Adult Patients With Metastatic Prostate Cancer
Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC)

All Metastatic Castration-Sensitive Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT06120491
Acronym / sponsor ID: EvoPAR-PR01 / D9723C00001
Conditions: Metastatic Castration-Sensitive Prostate Cancer
Keywords: AZD5305; Saruparib; HRRm; non-HRRm; mCSPC; Prostate Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1,898 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 21 Nov 2023 (actual)
Primary completion: 30 Sep 2027 (estimated)
Study completion: 30 Apr 2031 (estimated)
First posted: 7 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Within each cohort (HRRm and non-HRRm), participants are randomised in 1:1 ratio to one of two treatment arms

Arm	Type	Receives
Arm 1: Saruparib (AZD5305) + Physician's Choice NHA	Experimental	Drug: Saruparib, Drug: Abiraterone Acetate, Drug: Darolutamide, Drug: EnzalutamideSaruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Arm 2: Placebo + Physician's Choice NHA	Placebo comparator	Drug: Placebo, Drug: Abiraterone Acetate, Drug: Darolutamide, Drug: EnzalutamidePlacebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)

Who may qualify

Ages: 18 to 130 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SaruparibAlso: AZD5305Oral	Drug	Arm 1: Saruparib (AZD5305) + Physician's Choice NHA
PlaceboOral	Drug	Arm 2: Placebo + Physician's Choice NHA
Abiraterone AcetateAlso: ZytigaOral	Drug	Arm 1: Saruparib (AZD5305) + Physician's Choice NHA, Arm 2: Placebo + Physician's Choice NHA
DarolutamideAlso: NubeqaOral	Drug	Arm 1: Saruparib (AZD5305) + Physician's Choice NHA, Arm 2: Placebo + Physician's Choice NHA
EnzalutamideAlso: XtandiOral	Drug	Arm 1: Saruparib (AZD5305) + Physician's Choice NHA, Arm 2: Placebo + Physician's Choice NHA

Primary outcome

Radiographic Progression-Free Survival (rPFS)
Time frame: Up to approximately 50 months
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.

13 secondary outcomes

Overall Survival (OS)
Time frame: Up to approximately 90 months
Second Progression-Free Survival (PFS2)
Time frame: Up to approximately 50 months
Time to First Subsequent Therapy or Death (TFST)
Time frame: Up to approximately 50 months
Symptomatic Skeletal Event-Free Survival (SSE-FS)
Time frame: Up to approximately 50 months
Time to the First Castration-Resistant Event (TTCR)
Time frame: Up to approximately 50 months
Time to Pain Progression (TTPP)
Time frame: Up to approximately 50 months
Time To Deterioration in Urinary Symptoms (TTDUS)
Time frame: Up to approximately 50 months
Time to Deterioration in Physical Function (TTDPF)
Time frame: Up to approximately 50 months
Health-related Quality of Life (HrQoL)
Time frame: Up to approximately 50 months
BRCA, other HRR gene mutation and HRD status
Time frame: At screening
Plasma concentrations of AZD5305
Time frame: Up to approximately 10 months
Samples will be used to develop complementary or companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
Time frame: Up to approximately 50 months
Assessment of PSA (prostate-specific antigen) in participants in mCSPC
Time frame: Up to approximately 50 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Derived from this study: PubMed 41979035Azad 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.
Individual participant dataSharing planned: Yes. 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.

Related trials for Metastatic Castration-Sensitive Prostate Cancer

RecruitingPhase 1
A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer
Not yet recruitingPhase 1/2
RYZ711 Diagnostic Platform Study
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RecruitingObservational study
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
RecruitingPhase 2
Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma
RecruitingPhase 1
JUR-003 in Adult Patients With Metastatic Prostate Cancer
Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kim Nguyen Chi, MD principal investigator

BC Cancer, Canada

Arun Azad, MD principal investigator

Peter MacCallum Cancer Centre, Australia

322 sites in 24 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saruparib, Abiraterone Acetate and Darolutamide in people with Metastatic Castration-Sensitive Prostate Cancer, run by AstraZeneca at 322 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 322 sites in United States, China, Japan, Germany, Canada and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-Free Survival (rPFS) (time frame: Up to approximately 50 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06120491, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.