Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Phase 3EvoPAR-PR05NCT07711002

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)

A Phase 3 study testing Saruparib, Enzalutamide and Darolutamide in people with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by AstraZeneca at 210 sites in 21 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
What is being tested?: Saruparib, Enzalutamide and Darolutamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,330 participants
Where: 210 sitesin 21 countries
Study dates: 15 Sep 2026to 27 May 2033
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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.
- -

Who cannot join

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.

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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.
- -

Trial locations and contacts

210 sites in 21 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

210 sites in 21 countries

United States42 sites, 40 recruiting

Research Site
Aberdeen, South Dakota, 57401
Not yet recruiting
Research Site
Albuquerque, New Mexico, 87109
Not yet recruiting
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Ames, Iowa, 50010
Not yet recruiting
Research Site
Austin, Texas, 78745
Not yet recruiting
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Baltimore, Maryland, 21201
Not yet recruiting
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Baltimore, Maryland, 21229
Not yet recruiting
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Beverly Hills, California, 90211
Not yet recruiting
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Camden, New Jersey, 08103
Not yet recruiting
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Canton, Ohio, 44718
Not yet recruiting
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Chicago, Illinois, 60637
Not yet recruiting
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Chicago, Illinois, 60657
Not yet recruiting
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Cincinnati, Ohio, 45267
Not yet recruiting
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Dallas, Texas, 75235
Not yet recruiting
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Detroit, Michigan, 48202
Not yet recruiting
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Elk Grove Village, Illinois, 60007
Not yet recruiting
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Fort Worth, Texas, 76104
Not yet recruiting
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Grand Rapids, Michigan, 49503
Not yet recruiting
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Greenville, South Carolina, 29607
Not yet recruiting
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Hinsdale, Illinois, 60521
Not yet recruiting
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Honolulu, Hawaii, 96813
Not yet recruiting
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Hot Springs, Arkansas, 71913
Not yet recruiting
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Longview, Texas, 75605
Not yet recruiting
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Los Alamitos, California, 90720
Not yet recruiting
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Los Angeles, California, 90089
Not yet recruiting
Research Site
Margate, Florida, 33063
Recruiting
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Marshall, Minnesota, 56258
Not yet recruiting
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Miami, Florida, 33165
Recruiting
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Mitchell, South Dakota, 57301
Not yet recruiting
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Nashville, Tennessee, 37203
Not yet recruiting
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Orlando, Florida, 32806
Not yet recruiting
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Pierre, South Dakota, 57501
Not yet recruiting
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Portland, Oregon, 97213
Not yet recruiting
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Portland, Oregon, 97227
Not yet recruiting
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Salt Lake City, Utah, 84112
Withdrawn
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San Diego, California, 92123
Withdrawn
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Shirley, New York, 11967
Not yet recruiting
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Sioux Falls, South Dakota, 57105
Not yet recruiting
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Spokane, Washington, 99202
Not yet recruiting
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Springdale, Arkansas, 72762
Recruiting
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Towson, Maryland, 21204
Not yet recruiting
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Wichita Falls, Texas, 76310
Not yet recruiting
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Yankton, South Dakota, 57078
Not yet recruiting

Other trials in United States

China27 sites, 27 recruiting

Research Site
Beijing, 100730
Not yet recruiting
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Changsha, 410013
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Chengdu, 610031
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Chengdu, 610078
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Chongqing, 400030
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Fuzhou, 350005
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Guangzhou, 510289
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Guangzhou, 510515
Not yet recruiting
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Guiyang, 550044
Not yet recruiting
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Jiaxing, 314001
Not yet recruiting
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Jinan, 250021
Not yet recruiting
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Kunming, 650101
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Kunming, 650118
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Lanzhou, 730030
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Nanchang, 330000
Not yet recruiting
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Nanjing, 210009
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Nantong, 226361
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Ningbo, 315020
Not yet recruiting
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Qingdao, 266035
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Shandong
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Shanghai, 200025
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Shanghai, 200080
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Wenzhou, 325000
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Wuhan, 430030
Not yet recruiting
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Wuhan, 430048
Not yet recruiting
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Wuhan, 430079
Not yet recruiting
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Xi'an, 710061
Not yet recruiting

Other trials in China

Germany24 sites, 24 recruiting

Research Site
Bergisch Gladbach, 51465
Not yet recruiting
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Berlin, 10967
Not yet recruiting
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Berlin, 12157
Not yet recruiting
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Bonn, 53127
Not yet recruiting
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Cologne, 50968
Not yet recruiting
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Dresden, 01307
Not yet recruiting
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Duisburg, 47169
Not yet recruiting
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Essen, 45147
Not yet recruiting
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Frankfurt am Main, 60590
Not yet recruiting
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Göttingen, 37075
Not yet recruiting
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Hamburg, 20246
Not yet recruiting
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Heidelberg, 69120
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Herne, 44625
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Mannheim, 68167
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Marburg, 35043
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Mettmann, 40822
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München, 81377
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Münster, 48149
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Nuremberg, 90419
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Nürtingen, 72622
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Rostock, 18057
Not yet recruiting
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Stuttgart, 70174
Not yet recruiting
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Ulm, 89081
Not yet recruiting
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Würzburg, 97080
Not yet recruiting

Other trials in Germany

Japan21 sites, 21 recruiting

Research Site
Chiba, 260-8717
Not yet recruiting
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Fukuoka, 811-1395
Not yet recruiting
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Fukuoka, 812-8582
Not yet recruiting
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Hiroshima, 734-8551
Not yet recruiting
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Kamakura-shi, 247-8533
Not yet recruiting
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Kawagoe-shi, 350-8550
Not yet recruiting
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Kisarazu-shi, 292-8535
Not yet recruiting
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Kita-gun, 761-0793
Not yet recruiting
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Kobe, 650-0047
Not yet recruiting
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Kumamoto, 860-0008
Not yet recruiting
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Maebashi, 371-8511
Not yet recruiting
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Nagano, 381-8551
Not yet recruiting
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Nagasaki, 852-8501
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Nagoya, 466-8560
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Nagoya, 467-8602
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Osaka, 541-8567
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Sakai, 590-0197
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Sakura-shi, 285-8741
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Sapporo, 060-8543
Not yet recruiting
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Suita-shi, 565-0871
Not yet recruiting
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Yokohama, 232-0024
Not yet recruiting

Other trials in Japan

Canada14 sites, 14 recruiting

Research Site
Abbotsford British Columbia, British Columbia, V2S0C2
Not yet recruiting
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Brampton, Ontario, L6R 3J7
Not yet recruiting
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Calgary, Alberta, T2N 5G2
Not yet recruiting
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Edmonton, Alberta, T6G 1Z2
Not yet recruiting
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Greenfield Park, Quebec, J4V 2H1
Not yet recruiting
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Kitchener, Ontario, N2G 1G
Not yet recruiting
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Montreal, Quebec, H2X 0A9
Recruiting
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Montreal, Quebec, H3T 1E2
Not yet recruiting
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North York, Ontario, M2K 1E1
Not yet recruiting
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Ottawa, Ontario, K1H 7W9
Not yet recruiting
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Saint-Jérôme, Quebec, J7Z 5T3
Not yet recruiting
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Saskatoon, Saskatchewan, S7N 4H4
Not yet recruiting
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Toronto, Ontario, M5G 2M9
Not yet recruiting
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Windsor, Ontario, N8W 1L9
Not yet recruiting

Other trials in Canada

Poland8 sites, 8 recruiting

Research Site
Gdansk, 80-219
Not yet recruiting
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Koszalin, 75-581
Not yet recruiting
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Krakow, 31-501
Not yet recruiting
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Lodz, 93-513
Not yet recruiting
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Olsztyn, 10-228
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Poznan, 61-731
Not yet recruiting
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Warsaw, 02-781
Not yet recruiting
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Wroclaw, 53-413
Not yet recruiting

Other trials in Poland

Spain8 sites, 8 recruiting

Research Site
Barcelona, 08036
Not yet recruiting
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Barcelona, 08041
Not yet recruiting
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Córdoba, 14004
Not yet recruiting
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Las Palmas de Gran Canaria, 35016
Not yet recruiting
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Madrid, 28034
Not yet recruiting
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Madrid, 28041
Not yet recruiting
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Santander, 39008
Not yet recruiting
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Valencia, 46014
Not yet recruiting

Other trials in Spain

Brazil7 sites, 7 recruiting

Research Site
Barretos, 14784-400
Not yet recruiting
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Brasília, 71681-603
Not yet recruiting
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Natal, 59020-400
Not yet recruiting
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Porto Alegre, 90035-000
Not yet recruiting
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São Caetano do Sul, 09541-270
Not yet recruiting
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São Paulo, 01327-001
Not yet recruiting
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São Paulo, 05652-900
Not yet recruiting

Other trials in Brazil

India7 sites, 7 recruiting

Research Site
Ansārinagar, 110 029
Not yet recruiting
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Bangalore, 560004
Not yet recruiting
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Delhi, 110085
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Kannur, 670103
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Nagpur, 440001
Not yet recruiting
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New Delhi, 110029
Not yet recruiting
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Vadodara, 391760
Not yet recruiting

Other trials in India

South Korea6 sites, 6 recruiting

Research Site
Daegu, 41404
Recruiting
Research Site
Goyang-si, 10408
Not yet recruiting
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Seoul, 03080
Not yet recruiting
Research Site
Seoul, 06273
Not yet recruiting
Research Site
Seoul, 06591
Not yet recruiting
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Seoul, 5505
Not yet recruiting

Other trials in South Korea

Taiwan6 sites, 5 recruiting

Research Site
Kaohsiung City, 83301
Not yet recruiting
Research Site
Taichung, 43503
Withdrawn
Research Site
Tainan, 70403
Recruiting
Research Site
Taipei, 100
Not yet recruiting
Research Site
Taipei, 11217
Not yet recruiting
Research Site
Taoyuan, 00333
Not yet recruiting

Other trials in Taiwan

Turkey (Türkiye)6 sites, 6 recruiting

Research Site
Adana, 1330
Not yet recruiting
Research Site
Ankara, 06010
Not yet recruiting
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Ankara, 06620
Not yet recruiting
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Cordaleo, 35575
Not yet recruiting
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Istanbul, 34098
Not yet recruiting
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Izmir, 35340
Not yet recruiting

Other trials in Turkey (Türkiye)

United Kingdom6 sites, 6 recruiting

Research Site
Cambridge, CB2 0QQ
Not yet recruiting
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Glasgow, G12 OYN
Not yet recruiting
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London, EC1A 7BE
Not yet recruiting
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London, SW170QT
Not yet recruiting
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Manchester, M20 4BX
Not yet recruiting
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Plymouth, PL6 8DH
Not yet recruiting

Other trials in United Kingdom

France5 sites, 5 recruiting

Research Site
Angers, 49100
Not yet recruiting
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Caen, 14076
Not yet recruiting
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Montpellier, 34298
Not yet recruiting
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Paris, 75014
Not yet recruiting
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Poitiers, 86021
Not yet recruiting

Other trials in France

Hungary5 sites, 5 recruiting

Research Site
Budapest, 1062
Not yet recruiting
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Budapest, 1082
Not yet recruiting
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Budapest, 1122
Not yet recruiting
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Pécs, 7624
Not yet recruiting
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Szeged, 6725
Not yet recruiting

Other trials in Hungary

Thailand5 sites, 5 recruiting

Research Site
Bangkok, 10210
Not yet recruiting
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Bangkok, 10400
Not yet recruiting
Research Site
Bangkok, 10700
Not yet recruiting
Research Site
Khlong Luang, 12120
Not yet recruiting
Research Site
Songkhla, 90110
Not yet recruiting

Other trials in Thailand

Austria4 sites, 4 recruiting

Research Site
Graz, 8036
Not yet recruiting
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Linz, 4020
Not yet recruiting
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Salzburg, 5020
Not yet recruiting
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Vienna, 1090
Not yet recruiting

Other trials in Austria

Italy4 sites, 4 recruiting

Research Site
Bari, 70124
Not yet recruiting
Research Site
Genova, 16132
Not yet recruiting
Research Site
Padova, 35128
Not yet recruiting
Research Site
Rozzano, 20089
Not yet recruiting

Other trials in Italy

Hong Kong2 sites, 2 recruiting

Research Site
Hong Kong, 999077
Not yet recruiting
Research Site
Hong Kong
Not yet recruiting

Other trials in Hong Kong

Switzerland2 sites, 2 recruiting

Research Site
Aarau, 5001
Not yet recruiting
Research Site
Chur, 7000
Not yet recruiting

Other trials in Switzerland

Puerto Rico1 site, 1 recruiting

Research Site
Rio Piedras, 00935
Not yet recruiting

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05

Conditions: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Being tested: Saruparib, Placebo, Enzalutamide, Darolutamide, Abiraterone
Keywords: Saruparib, HRRm, non-HRRm, mHSPC, Prostate Cancer, AZD5305, PSA>0.2ng/ml, Androgen pathway modulation sensitive (APMS), Castration sensitive, Metastatic prostate cancer, Hormone sensitive prostate cancer, PARPi, Docetaxel, PSMA-directed 177Lutetium
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
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)
PlaceboOther
Arm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)
EnzalutamideDrug
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
DarolutamideDrug
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI
AbirateroneDrug
Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI

Study groups in NCT07711002
Study group	Role	What they receive
Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone	Experimental	Saruparib 60 mg + ARPI (enzalutamide, darolutamide, or abiraterone) : Participants will receive saruparib 60 mg orally once daily in combination with physician's choice of ARPI in cycles of 28 days Receives: Drug: Saruparib; Drug: Enzalutamide; Drug: Darolutamide; Drug: Abiraterone
Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone	Placebo comparator	Placebo + ARPI (enzalutamide, darolutamide, or abiraterone): Participants will receive placebo orally once daily in combination with physician's choice of ARPI in cycles of 28 days Receives: Other: Placebo; Drug: Enzalutamide; Drug: Darolutamide; Drug: Abiraterone

What is being measured

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

Radiographic progression-free survival (rPFS)
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.
Measured: Up to approximately 56 months

Secondary outcomes (12)

Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause.
Measured: Up to approximately 80 months
Radiographic progression-free survival (rPFS)
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.
Measured: Up to approximately 56 months
Time to Second Progression or Death (PFS2)
PFS2 is defined as the time from randomization to the earliest progression (defined as radiographic progression, clinical progression, or PSA progression) after initiation of first subsequent treatment following the initial investigator-assessed progression or death (ie, date of PFS2 event or censoring - date of randomization + 1).
Measured: Up to approximately 56 months
Time to First Subsequent Therapy or Death (TFST)
TFST is defined as the time from randomization to the start date of the first subsequent anticancer therapy after discontinuation of randomized treatment, or death due to any cause (ie, date of first subsequent cancer therapy or death - date of randomization + 1).
Measured: Up to approximately 56 months
Symptomatic Skeletal Event-free Survival (SSE-FS)
SSE-FS is defined as the time from the date of randomization 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).
Radiographic documentation is required. A pathological fracture, as determined by investigator, is defined as associated with low or no trauma and deemed to have occurred at a site of bone metastasis.
- Occurrence of spinal cord compression. Radiographic documentation is required.
- Orthopedic surgical intervention for bone metastasis.
- Death due to any cause.
Measured: Up to approximately 56 months
Time to Castration Resistance (TTCR)
TTCR is defined as the time from randomization to the first castration-resistant event (radiographic disease progression, PSA progression per PCWG3, or SSE, whichever occurs first, with castrate levels of testosterone below 50 ng/dL).
Measured: Up to approximately 56 months
Time to PSA progression
Time to PSA progression, defined as the time from randomization to PSA progression per PCWG3 criteria.
Measured: Up to approximately 56 months
Time to deterioration in physical function (TTDPF)
TTDPF is defined as the time from randomization to deterioration in PROMIS SF-PF scores.
Measured: Up to approximately 56 months
Time to pain progression (TTPP)
TTPP is defined as the time from randomization to clinically meaningful pain progression based on a 2-point increase from baseline in the BPI-SF Item 3 'worst pain in 24 hours' score and/or initiation of/increase in opioid analgesic use.
Measured: Up to approximately 56 months
Brief Pain Inventory - Short Form (BPI-SF)
Change from baseline in BPI-SF worst pain score, pain severity and interference domain scores.
Measured: Up to approximately 56 months
Time to deterioration in urinary symptoms (TTDUS)
TTDUS is defined as the time from randomization to deterioration in the EORTC QLQ-PR25(US) subscale scores.
Measured: Up to approximately 56 months
Plasma concentrations of AZD5305
To assess PK of AZD5305 in plasma
Measured: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (each cycle is of 28 days)

Timeline

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

15 Sep 202627 May 2033

First posted17 Jul 2026
Study start15 Sep 2026
Primary completion30 May 2031 (estimated)
Study completion27 May 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Studies 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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,330 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07711002
Sponsor's protocol ID: D972DC00001
Other IDs: 2026-526275-38-00
Acronym: EvoPAR-PR05
Status last verified: Oct 2026
First submitted: 14 Jul 2026
Last updated: 15 Oct 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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

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?

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RecruitingPhase 1/2
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

All Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05
ClinicalTrials.gov ID: NCT07711002
Acronym / sponsor ID: EvoPAR-PR05 / D972DC00001
Conditions: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Keywords: Saruparib, HRRm, non-HRRm, mHSPC, Prostate Cancer, AZD5305, PSA>0.2ng/ml, Androgen pathway modulation sensitive (APMS)
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,330 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 15 Sep 2026 (actual)
Primary completion: 30 May 2031 (estimated)
Study completion: 27 May 2033 (estimated)
First posted: 17 Jul 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone	Experimental	Drug: Saruparib, Drug: Enzalutamide, Drug: Darolutamide, Drug: AbirateroneSaruparib 60 mg + ARPI (enzalutamide, darolutamide, or abiraterone) : Participants will receive saruparib 60 mg orally once daily in combination with physician's choice of ARPI in cycles of 28 days
Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone	Placebo comparator	Other: Placebo, Drug: Enzalutamide, Drug: Darolutamide, Drug: AbirateronePlacebo + ARPI (enzalutamide, darolutamide, or abiraterone): Participants will receive placebo orally once daily in combination with physician's choice of ARPI in cycles of 28 days

Who may qualify

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

Key inclusion criteria (19 listed)

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:

Key exclusion criteria (13 listed)

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

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
SaruparibArm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)	Drug	Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone
PlaceboArm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)	Other	Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone
EnzalutamideArm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI	Drug	Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone, Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone
DarolutamideArm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI	Drug	Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone, Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone
AbirateroneArm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI	Drug	Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone, Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone

Primary outcome

Radiographic progression-free survival (rPFS)
Time frame: 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.

12 secondary outcomes

Overall Survival (OS)
Time frame: Up to approximately 80 months
Radiographic progression-free survival (rPFS)
Time frame: Up to approximately 56 months
Time to Second Progression or Death (PFS2)
Time frame: Up to approximately 56 months
Time to First Subsequent Therapy or Death (TFST)
Time frame: Up to approximately 56 months
Symptomatic Skeletal Event-free Survival (SSE-FS)
Time frame: Up to approximately 56 months
Time to Castration Resistance (TTCR)
Time frame: Up to approximately 56 months
Time to PSA progression
Time frame: Up to approximately 56 months
Time to deterioration in physical function (TTDPF)
Time frame: Up to approximately 56 months
Time to pain progression (TTPP)
Time frame: Up to approximately 56 months
Brief Pain Inventory - Short Form (BPI-SF)
Time frame: Up to approximately 56 months
Time to deterioration in urinary symptoms (TTDUS)
Time frame: Up to approximately 56 months
Plasma concentrations of AZD5305
Time frame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (each cycle is of 28 days)

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 15 Oct 2026.
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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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RecruitingPhase 1/2
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

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.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

210 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saruparib, Enzalutamide and Darolutamide in people with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by AstraZeneca at 210 sites in 21 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 19 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in United States, China, Germany, Japan, Canada and 16 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?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic progression-free survival (rPFS) (time frame: Up to approximately 56 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 NCT07711002.

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 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.