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.
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
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
210 sites in 21 countries
United States42 sites, 40 recruiting
- Not yet recruiting
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Aberdeen, South Dakota, 57401
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Albuquerque, New Mexico, 87109
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Ames, Iowa, 50010
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Austin, Texas, 78745
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21229
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Beverly Hills, California, 90211
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Camden, New Jersey, 08103
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Canton, Ohio, 44718
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Chicago, Illinois, 60637
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Chicago, Illinois, 60657
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Cincinnati, Ohio, 45267
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Dallas, Texas, 75235
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Detroit, Michigan, 48202
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Elk Grove Village, Illinois, 60007
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Fort Worth, Texas, 76104
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Grand Rapids, Michigan, 49503
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Greenville, South Carolina, 29607
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Hinsdale, Illinois, 60521
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Honolulu, Hawaii, 96813
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Hot Springs, Arkansas, 71913
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Longview, Texas, 75605
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Los Alamitos, California, 90720
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Los Angeles, California, 90089
- Recruiting
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Margate, Florida, 33063
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Marshall, Minnesota, 56258
- Recruiting
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Miami, Florida, 33165
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Mitchell, South Dakota, 57301
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Nashville, Tennessee, 37203
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Orlando, Florida, 32806
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Pierre, South Dakota, 57501
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Portland, Oregon, 97213
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Portland, Oregon, 97227
- Withdrawn
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Salt Lake City, Utah, 84112
- Withdrawn
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San Diego, California, 92123
- Not yet recruiting
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Shirley, New York, 11967
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Sioux Falls, South Dakota, 57105
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Spokane, Washington, 99202
- Recruiting
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Springdale, Arkansas, 72762
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Towson, Maryland, 21204
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Wichita Falls, Texas, 76310
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Yankton, South Dakota, 57078
China27 sites, 27 recruiting
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Beijing, 100730
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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
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Guiyang, 550044
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Jiaxing, 314001
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Jinan, 250021
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Kunming, 650101
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Kunming, 650118
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Lanzhou, 730030
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Nanchang, 330000
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Nanjing, 210009
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Nantong, 226361
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Ningbo, 315020
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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
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Wuhan, 430048
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Wuhan, 430079
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Xi'an, 710061
Germany24 sites, 24 recruiting
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Bergisch Gladbach, 51465
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Berlin, 10967
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Berlin, 12157
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Bonn, 53127
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Cologne, 50968
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Dresden, 01307
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Duisburg, 47169
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Essen, 45147
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Frankfurt am Main, 60590
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Göttingen, 37075
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Hamburg, 20246
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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
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Stuttgart, 70174
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Ulm, 89081
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Würzburg, 97080
Japan21 sites, 21 recruiting
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Chiba, 260-8717
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Fukuoka, 811-1395
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Fukuoka, 812-8582
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Hiroshima, 734-8551
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Kamakura-shi, 247-8533
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Kawagoe-shi, 350-8550
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Kisarazu-shi, 292-8535
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Kita-gun, 761-0793
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Kobe, 650-0047
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Kumamoto, 860-0008
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Maebashi, 371-8511
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Nagano, 381-8551
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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
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Suita-shi, 565-0871
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Yokohama, 232-0024
Canada14 sites, 14 recruiting
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Abbotsford British Columbia, British Columbia, V2S0C2
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Brampton, Ontario, L6R 3J7
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Calgary, Alberta, T2N 5G2
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Edmonton, Alberta, T6G 1Z2
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Greenfield Park, Quebec, J4V 2H1
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Kitchener, Ontario, N2G 1G
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Montreal, Quebec, H2X 0A9
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Montreal, Quebec, H3T 1E2
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North York, Ontario, M2K 1E1
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Ottawa, Ontario, K1H 7W9
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Saint-Jérôme, Quebec, J7Z 5T3
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Saskatoon, Saskatchewan, S7N 4H4
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Toronto, Ontario, M5G 2M9
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Windsor, Ontario, N8W 1L9
Poland8 sites, 8 recruiting
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Gdansk, 80-219
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Koszalin, 75-581
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Krakow, 31-501
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Lodz, 93-513
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Olsztyn, 10-228
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Poznan, 61-731
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Warsaw, 02-781
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Wroclaw, 53-413
Spain8 sites, 8 recruiting
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Barcelona, 08036
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Barcelona, 08041
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Córdoba, 14004
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Las Palmas de Gran Canaria, 35016
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Madrid, 28034
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Madrid, 28041
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Santander, 39008
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Valencia, 46014
Brazil7 sites, 7 recruiting
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Barretos, 14784-400
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Brasília, 71681-603
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Natal, 59020-400
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Porto Alegre, 90035-000
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São Caetano do Sul, 09541-270
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São Paulo, 01327-001
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São Paulo, 05652-900
India7 sites, 7 recruiting
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Ansārinagar, 110 029
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Bangalore, 560004
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Delhi, 110085
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Kannur, 670103
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Nagpur, 440001
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New Delhi, 110029
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Vadodara, 391760
South Korea6 sites, 6 recruiting
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Daegu, 41404
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Goyang-si, 10408
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Seoul, 03080
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Seoul, 06273
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Seoul, 06591
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Seoul, 5505
Taiwan6 sites, 5 recruiting
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Kaohsiung City, 83301
- Withdrawn
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Taichung, 43503
- Recruiting
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Tainan, 70403
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Taipei, 100
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Taipei, 11217
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Taoyuan, 00333
Turkey (Türkiye)6 sites, 6 recruiting
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Adana, 1330
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Ankara, 06010
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Ankara, 06620
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Cordaleo, 35575
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Istanbul, 34098
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Izmir, 35340
United Kingdom6 sites, 6 recruiting
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Cambridge, CB2 0QQ
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Glasgow, G12 OYN
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London, EC1A 7BE
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London, SW170QT
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Manchester, M20 4BX
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Plymouth, PL6 8DH
France5 sites, 5 recruiting
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Angers, 49100
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Caen, 14076
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Montpellier, 34298
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Paris, 75014
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Poitiers, 86021
Hungary5 sites, 5 recruiting
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Budapest, 1062
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Budapest, 1082
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Budapest, 1122
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Pécs, 7624
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Szeged, 6725
Thailand5 sites, 5 recruiting
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Bangkok, 10210
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Bangkok, 10400
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Bangkok, 10700
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Khlong Luang, 12120
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Songkhla, 90110
Austria4 sites, 4 recruiting
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Graz, 8036
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Linz, 4020
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Salzburg, 5020
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Vienna, 1090
Italy4 sites, 4 recruiting
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Bari, 70124
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Genova, 16132
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Padova, 35128
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Rozzano, 20089
Hong Kong2 sites, 2 recruiting
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Hong Kong, 999077
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Hong Kong
Switzerland2 sites, 2 recruiting
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Aarau, 5001
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Chur, 7000
Puerto Rico1 site, 1 recruiting
- Not yet recruiting
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Rio Piedras, 00935
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
The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng/mL.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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.