Prostate CancerPhase 3EvoPAR-PR02NCT06952803
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation
A Phase 3 study testing Saruparib, Abiraterone + Prednisolone/Prednisone and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer, run by AstraZeneca at 346 sites in 28 countries.
Trial summary
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Saruparib, Abiraterone + Prednisolone/Prednisone and Androgen Deprivation Therapy (ADT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 346 sitesin 28 countries
- Study dates
- 6 Aug 2025to 30 Apr 2036
- 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
- Male participants with a histologically documented diagnosis of prostate adenocarcinoma.
- Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.
- Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.
- Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.
- Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
- Participants required to have a prostate-specific membrane antigen-positron emission tomography (PSMA-PET) following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization.
- Minimum life expectancy of 12 months.
- Adequate organ and bone marrow function as described in study protocol.
- All participants will have received either primary or salvage RT. Participants must be eligible for randomisation within 10 months of initial diagnosis (de novo or BCR). Radiotherapy administered to the prostate (± pelvis) either in the primary or salvage setting must be delivered with curative intent. Use of metastases-directed therapy, as part of the RT radiation plan, is permitted as localised RT treatment for a metastatic lesion(s) outside the pelvis.
- All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.
- Participants must not father children or donate sperm from signing informed consent form (ICF), during the study intervention and for 6 months after the last dose of study intervention.
- Participants must use a condom (with spermicide - where permitted) 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 myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Participants with any known predisposition to bleeding [e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy].
- Any history of persisting (> 2 weeks) severe cytopenia due to any cause.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib and/or abiraterone.
- History of another primary malignancy, with exceptions.
- Persistent toxicities [Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2] caused by previous anticancer therapy.
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- Cardiac criteria, including history of arrhythmia and cardiovascular disease.
- Evidence of active and uncontrolled hepatitis B and/or hepatitis C.
- Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.
- Active tuberculosis infection.
- Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor.
- Prior treatment within 14 days with blood product support or growth factor support.
- Concomitant use of strong inducers and inhibitors of CYP3A4 (applies to saruparib and abiraterone) or herbal supplements within 21 days or at least 5 half-lives (whichever is longer), of randomization.
- Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).
- Participants with a known hypersensitivity to saruparib or any excipients of these products.
Trial locations and contacts
346 sites in 28 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
346 sites in 28 countries
United States45 sites, 37 recruiting
- Withdrawn
Research Site
Albany, New York, 12206
- Recruiting
Research Site
Austin, Texas, 78705
- Recruiting
Research Site
Austin, Texas, 78745
- Withdrawn
Research Site
Bethesda, Maryland, 20817
- Recruiting
Research Site
Chicago, Illinois, 60611
- Recruiting
Research Site
Chicago Ridge, Illinois, 60415
- Recruiting
Research Site
Columbus, Ohio, 43230
- Recruiting
Research Site
Greenwood, Indiana, 46143
- Recruiting
Research Site
Hackensack, New Jersey, 07601
- Recruiting
Research Site
Hershey, Pennsylvania, 17033
- Recruiting
Research Site
Hialeah, Florida, 33016
- Recruiting
Research Site
Houston, Texas, 77074
- Recruiting
Research Site
Jacksonville, Florida, 32224
- Withdrawn
Research Site
Jeffersonville, Indiana, 47130
- Recruiting
Research Site
La Jolla, California, 92037
- Recruiting
Research Site
La Jolla, California, 92093
- Withdrawn
Research Site
Lake Barrington, Illinois, 60010
- Recruiting
Research Site
Lakewood, Colorado, 80215
- Recruiting
Research Site
Lancaster, Pennsylvania, 17601
- Recruiting
Research Site
Los Angeles, California, 90048
- Recruiting
Research Site
Myrtle Beach, South Carolina, 29572
- Recruiting
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Nashville, Tennessee, 37209
- Recruiting
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New York, New York, 10065
- Recruiting
Research Site
Newnan, Georgia, 30265
- Recruiting
Research Site
Norfolk, Virginia, 23502
- Recruiting
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Phoenix, Arizona, 85054
- Recruiting
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Pittsburgh, Pennsylvania, 15212
- Recruiting
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Plymouth, Massachusetts, 02360
- Recruiting
Research Site
Providence, Rhode Island, 02903
- Recruiting
Research Site
Roanoke, Virginia, 24014
- Recruiting
Research Site
Rochester, Minnesota, 55905
- Withdrawn
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Salt Lake City, Utah, 84112
- Recruiting
Research Site
San Antonio, Texas, 78229
- Recruiting
Research Site
San Diego, California, 92123
- Recruiting
Research Site
San Luis Obispo, California, 93401
- Withdrawn
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Seattle, Washington, 98109
- Recruiting
Research Site
Spring, Texas, 77380
- Recruiting
Research Site
Springfield, Oregon, 97477
- Recruiting
Research Site
Syracuse, New York, 13210
- Withdrawn
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Tallahassee, Florida, 32308
- Recruiting
Research Site
Tampa, Florida, 33612
- Recruiting
Research Site
Towson, Maryland, 21204
- Withdrawn
Research Site
Tucson, Arizona, 85741
- Recruiting
Research Site
Virginia Beach, Virginia, 23462
- Recruiting
Research Site
Voorhees Township, New Jersey, 08043
China30 sites, 27 recruiting
- Recruiting
Research Site
Beijing, 100020
- Recruiting
Research Site
Beijing, 100021
- Recruiting
Research Site
Beijing, 100176
- Recruiting
Research Site
Changchun, 130012
- Recruiting
Research Site
Changsha, 410013
- Recruiting
Research Site
Chongqing, 400016
- Recruiting
Research Site
Guangzhou, 510060
- Recruiting
Research Site
Guangzhou, 510080
- Recruiting
Research Site
Guangzhou, 510180
- Recruiting
Research Site
Guangzhou, 510280
- Not yet recruiting
Research Site
Hangzhou, 31000
- Recruiting
Research Site
Hangzhou, 310022
- Recruiting
Research Site
Jinan, 250021
- Recruiting
Research Site
Jinhua, 322100
- Withdrawn
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Lanzhou, 730030
- Recruiting
Research Site
Nanchang, 330006
- Recruiting
Research Site
Ningbo, 315010
- Recruiting
Research Site
Shanghai, 200025
- Withdrawn
Research Site
Shanghai, 20032
- Recruiting
Research Site
Shenyang, 110001
- Withdrawn
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Shenyang, 110042
- Recruiting
Research Site
Sichuan, 610041
- Recruiting
Research Site
Suining, 629018
- Recruiting
Research Site
Tianjin, 300201
- Recruiting
Research Site
Wuhan, 430022
- Recruiting
Research Site
Wuhan, 430060
- Recruiting
Research Site
Wuhu, 241000
- Recruiting
Research Site
Xiamen, 361003
- Recruiting
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Yangzhou, 225001
- Recruiting
Research Site
Zhuhai, 519099
Germany24 sites, 23 recruiting
- Recruiting
Research Site
Augsburg, 86156
- Recruiting
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Berlin, 10117
- Recruiting
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Braunschweig, 38126
- Recruiting
Research Site
Cologne, 50937
- Recruiting
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Dresden, 1307
- Recruiting
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Duisburg, 47169
- Recruiting
Research Site
Düsseldorf, 40226
- Recruiting
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Essen, 45147
- Recruiting
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Giessen, 35392
- Recruiting
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Göttingen, 37075
- Not yet recruiting
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Gronau, 48599
- Recruiting
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Hamburg, 20246
- Recruiting
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Herne, 44625
- Withdrawn
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Kiel, 24105
- Recruiting
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Lübeck, 23538
- Recruiting
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Marburg, 35043
- Recruiting
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Münster, 48149
- Recruiting
Research Site
Nuremberg, 90419
- Recruiting
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Nürtingen, 72622
- Recruiting
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Regensburg, 93053
- Recruiting
Research Site
Schwerin, 19049
- Recruiting
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Trier, 54292
- Recruiting
Research Site
Ulm, 89081
- Recruiting
Research Site
Würzburg, 97080
France22 sites, 20 recruiting
- Recruiting
Research Site
Angers, 49100
- Recruiting
Research Site
Bordeaux, 33000
- Recruiting
Research Site
Caen, 14076
- Recruiting
Research Site
Clermont-Ferrand, 63011
- Recruiting
Research Site
Le Mans, 72000
- Withdrawn
Research Site
Marseille, 13273
- Recruiting
Research Site
Montpellier, 34070
- Recruiting
Research Site
Montpellier, 34298
- Recruiting
Research Site
Nice, 06100
- Recruiting
Research Site
Nîmes, 30029
- Recruiting
Research Site
Paris, 75020
- Recruiting
Research Site
Paris, 75674
- Recruiting
Research Site
Paris, 75970
- Recruiting
Research Site
Pierre-Bénite, 69310
- Withdrawn
Research Site
Rennes, 35000
- Recruiting
Research Site
Saint-Herblain, 44805
- Recruiting
Research Site
Saint-Priest-en-Jarez, 42270
- Recruiting
Research Site
Strasbourg, 67200
- Recruiting
Research Site
Suresnes, 92151
- Recruiting
Research Site
Tours, 37044
- Recruiting
Research Site
Vandœuvre-lès-Nancy, 54511
- Recruiting
Research Site
Villejuif, 94805
Italy18 sites, 18 recruiting
- Recruiting
Research Site
Arezzo, 52100
- Recruiting
Research Site
Bari, 70124
- Recruiting
Research Site
Bergamo, 24125
- Recruiting
Research Site
Bergamo, 24127
- Not yet recruiting
Research Site
Chieti, 66100
- Recruiting
Research Site
Genoa, 16132
- Recruiting
Research Site
Milan, 20132
- Recruiting
Research Site
Milan, 20133
- Recruiting
Research Site
Milan, 20141
- Recruiting
Research Site
Naples, 80131
- Recruiting
Research Site
Palermo, 90127
- Recruiting
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Pisa, 56126
- Recruiting
Research Site
Roma, 00144
- Recruiting
Research Site
Roma, 00168
- Recruiting
Research Site
Rozzano, 20089
- Recruiting
Research Site
Torino, 10126
- Recruiting
Research Site
Varese, 21100
- Recruiting
Research Site
Verona, 37134
United Kingdom16 sites, 13 recruiting
- Recruiting
Research Site
Aberdeen, AB25 2ZN
- Recruiting
Research Site
Bristol, BS2 8ED
- Recruiting
Research Site
Cambridge, CB2 0QQ
- Recruiting
Research Site
Edinburgh, EH4 2XU
- Recruiting
Research Site
Exeter, EX2 5DW
- Recruiting
Research Site
Glasgow, G12 0YN
- Recruiting
Research Site
Greater London, SW3 6JJ
- Recruiting
Research Site
Guildford, GU2 7XX
- Withdrawn
Research Site
London, EC1M6BQ
- Recruiting
Research Site
London, NW3 2QG
- Recruiting
Research Site
London, WC1N 3BG
- Recruiting
Research Site
Manchester, M20 4BX
- Withdrawn
Research Site
Newcastle, NE7 7DN
- Recruiting
Research Site
Plymouth, PL6 8DH
- Withdrawn
Research Site
Preston, PR2 9HT
- Recruiting
Research Site
Romford, RM7 0AG
Brazil15 sites, 14 recruiting
- Not yet recruiting
Research Site
Barretos, 14784-400
- Recruiting
Research Site
Cachoeiro de Itapemirim, 29308-014
- Recruiting
Research Site
Curitiba, 80810-050
- Recruiting
Research Site
Curitiba
- Recruiting
Research Site
Jaú, 17210-120
- Recruiting
Research Site
Londrina, 86015-520
- Recruiting
Research Site
Pelotas, 96020-080
- Withdrawn
Research Site
Porto Alegre, 90035-000
- Recruiting
Research Site
Porto Alegre, 91350200
- Not yet recruiting
Research Site
Recife, 50070-460
- Recruiting
Research Site
Rio de Janeiro, 22.250-905
- Recruiting
Research Site
Rio de Janeiro, 22775-001
- Recruiting
Research Site
Salvador, 41950640
- Recruiting
Research Site
São Paulo, 01246-000
- Recruiting
Research Site
São Paulo, 01327-001
Japan15 sites, 15 recruiting
- Recruiting
Research Site
Bunkyō City, 113-8431
- Recruiting
Research Site
Fukuoka, 812-8582
- Recruiting
Research Site
Kamakura-shi, 247-8533
- Recruiting
Research Site
Kawagoe-shi, 350-8550
- Recruiting
Research Site
Kawasaki-shi, 216-8511
- Recruiting
Research Site
Kisarazu-shi, 292-8535
- Recruiting
Research Site
Kumamoto, 860-8556
- Not yet recruiting
Research Site
Kyoto, 606-8507
- Recruiting
Research Site
Maebashi, 371-8511
- Recruiting
Research Site
Miyazaki, 889-1692
- Recruiting
Research Site
Ōta-ku, 373-8550
- Recruiting
Research Site
Sagamihara-shi, 252-0375
- Recruiting
Research Site
Shimotsuke-shi, 329-0498
- Recruiting
Research Site
Yokohama, 232-0024
- Recruiting
Research Site
Yokohama, 241-8515
Spain14 sites, 14 recruiting
- Recruiting
Research Site
Barcelona, 08041
- Recruiting
Research Site
Barcelona, 8035
- Recruiting
Research Site
Girona, 17007
- Recruiting
Research Site
Madrid, 28040
- Recruiting
Research Site
Madrid, 28041
- Recruiting
Research Site
Madrid, 28046
- Recruiting
Research Site
Majadahonda, 28222
- Recruiting
Research Site
Málaga, 29009
- Recruiting
Research Site
Málaga, 29010
- Recruiting
Research Site
Oviedo, 33011
- Recruiting
Research Site
Sabadell, 08208
- Recruiting
Research Site
Santander, 39008
- Recruiting
Research Site
Valencia, 46009
- Recruiting
Research Site
Valencia, 46014
Argentina13 sites, 13 recruiting
- Recruiting
Research Site
CABA, 1426
- Recruiting
Research Site
CABA, C1113AAE
- Not yet recruiting
Research Site
Ciudad de Buenos Aires, 1181
- Recruiting
Research Site
Ciudad de Buenos Aires, 1426
- Recruiting
Research Site
Ciudad de Buenos Aires, C1419AHL
- Not yet recruiting
Research Site
Córdoba, 5000
- Recruiting
Research Site
Córdoba, X5008HHW
- Recruiting
Research Site
Cuidad Autónoma de Buenos Aire, C1426ANZ
- Recruiting
Research Site
La Plata, 1900
- Recruiting
Research Site
Pergamino, B2700CPM
- Recruiting
Research Site
Rosario, S2000KZE
- Not yet recruiting
Research Site
San Miguel de Tucumán, 4000
- Recruiting
Research Site
Viedma, R8500ACE
Turkey (Türkiye)13 sites, 12 recruiting
- Recruiting
Research Site
Ankara, 06010
- Recruiting
Research Site
Ankara, 06520
- Recruiting
Research Site
Ankara, 06620
- Recruiting
Research Site
Ankara, 06800
- Recruiting
Research Site
Cordaleo, 35575
- Recruiting
Research Site
Diyarbakır, 21280
- Recruiting
Research Site
Istanbul, 34010
- Recruiting
Research Site
Istanbul, 34098
- Recruiting
Research Site
Istanbul, 34722
- Recruiting
Research Site
Izmir, 35040
- Recruiting
Research Site
Şahinbey, 27310
- Recruiting
Research Site
Sakarya, 54290
- Withdrawn
Research Site
Seyhan, 01130
Canada11 sites
- Withdrawn
Research Site
Abbotsford British Columbia, British Columbia, V2S 0C2
- Withdrawn
Research Site
Barrie, Ontario, L4M 6M2
- Withdrawn
Research Site
Brampton, Ontario, L6R 3J7
- Withdrawn
Research Site
Calgary, Alberta, T2V 1P9
- Withdrawn
Research Site
Chicoutimi, Quebec, G7H 7K9
- Withdrawn
Research Site
London, Ontario, N6A 5A5
- Withdrawn
Research Site
Montreal, Quebec, H3T 1E2
- Withdrawn
Research Site
Saskatoon, Saskatchewan, S7N 4H4
- Withdrawn
Research Site
Toronto, Ontario, M5G 2M9
- Withdrawn
Research Site
Toronto, M4N 3M5
- Withdrawn
Research Site
Vancouver, British Columbia, V5Z 4E6
Israel11 sites, 11 recruiting
- Recruiting
Research Site
Afula, 18101
- Recruiting
Research Site
Beersheba, 8410101
- Not yet recruiting
Research Site
Hadera, 38100
- Recruiting
Research Site
Haifa, 31096
- Recruiting
Research Site
Jerusalem, 91031
- Recruiting
Research Site
Jerusalem, 9112001
- Recruiting
Research Site
Kfar Saba, 4428164
- Not yet recruiting
Research Site
Nahariya, 22100
- Recruiting
Research Site
Petah Tikva, 49100
- Recruiting
Research Site
Ramat Gan, 52621
- Recruiting
Research Site
Tel Aviv, 6423906
India10 sites, 8 recruiting
- Recruiting
Research Site
Ansārinagar, 110 029
- Recruiting
Research Site
Babgalore, 560069
- Withdrawn
Research Site
Calicut, 673601
- Withdrawn
Research Site
Delhi, 110085
- Recruiting
Research Site
Hyderabad, 500019
- Recruiting
Research Site
Kannur, 670103
- Recruiting
Research Site
Kanpur, 208005
- Recruiting
Research Site
Mumbai, 400012
- Recruiting
Research Site
Nagpur, 440001
- Recruiting
Research Site
Varanasi, 221005
South Korea10 sites, 9 recruiting
- Recruiting
Research Site
Busan, 49241
- Recruiting
Research Site
Daegu, 41404
- Recruiting
Research Site
Goyang-si, 10408
- Withdrawn
Research Site
Seongnam-si, 13620
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 06273
- Recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 06591
- Recruiting
Research Site
Seoul, 3722
- Recruiting
Research Site
Seoul, 5505
Belgium9 sites, 6 recruiting
- Withdrawn
Research Site
Brussels, 1070
- Recruiting
Research Site
Brussels, 1200
- Withdrawn
Research Site
Ghent, 9000
- Recruiting
Research Site
Jette, 1090
- Recruiting
Research Site
Kortrijk, 8500
- Withdrawn
Research Site
Leuven, 3000
- Recruiting
Research Site
Libramont-Chevigny, 6800
- Recruiting
Research Site
Roeselare, 8800
- Recruiting
Research Site
Wilrijk, 2610
Poland8 sites, 8 recruiting
- Recruiting
Research Site
Gdynia, 81-519
- Recruiting
Research Site
Gliwice, 44-101
- Recruiting
Research Site
Koszalin, 75-581
- Recruiting
Research Site
Krakow, 30-727
- Recruiting
Research Site
Piotrkow Trybunalski, 97-300
- Recruiting
Research Site
Poznan, 61-731
- Recruiting
Research Site
Rzeszów, 35-001
- Recruiting
Research Site
Warsaw, 04-073
Taiwan8 sites, 8 recruiting
- Recruiting
Research Site
Kaohsiung City, 83301
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Taichung, 43503
- Recruiting
Research Site
Tainan, 704
- Recruiting
Research Site
Taipei, 10055
- Recruiting
Research Site
Taipei, 110
- Recruiting
Research Site
Taipei, 112
- Recruiting
Research Site
Taoyuan, 333
Australia7 sites, 6 recruiting
- Withdrawn
Research Site
Kingswood, 2747
- Recruiting
Research Site
Murdoch, 6150
- Recruiting
Research Site
Orange, 2800
- Recruiting
Research Site
South Brisbane, 4101
- Recruiting
Research Site
St Leonards, 2065
- Recruiting
Research Site
Waratah, 2298
- Recruiting
Research Site
Woolloongabba, 4102
Hungary7 sites, 6 recruiting
- Recruiting
Research Site
Budapest, 1082
- Recruiting
Research Site
Budapest, 1122
- Withdrawn
Research Site
Budapest, H-1145
- Recruiting
Research Site
Debrecen, 4032
- Recruiting
Research Site
Győr, 9024
- Recruiting
Research Site
Gyula, 5700
- Recruiting
Research Site
Zalaegerszeg, 8900
Thailand7 sites, 7 recruiting
- Recruiting
Research Site
Bangkok, 10210
- Recruiting
Research Site
Bangkok, 10400
- Recruiting
Research Site
Bangkok, 10700
- Recruiting
Research Site
Khon Kaen, 40002
- Recruiting
Research Site
Muang, 50200
- Recruiting
Research Site
Pathum Thani, 12120
- Recruiting
Research Site
Songkhla, 90110
Finland6 sites, 6 recruiting
- Recruiting
Research Site
Helsinki, 00290
- Recruiting
Research Site
Helsinki, FI-00180
- Recruiting
Research Site
Kuopio, 70210
- Not yet recruiting
Research Site
Oulu, 90029
- Recruiting
Research Site
Tampere, FI-33521
- Recruiting
Research Site
Turku, 20520
Sweden6 sites, 5 recruiting
- Recruiting
Research Site
Gothenburg, 413 45
- Recruiting
Research Site
Malmö, 205 02
- Withdrawn
Research Site
Stockholm, 112 81
- Recruiting
Research Site
Stockholm, 141 86
- Recruiting
Research Site
Umeå, 901 85
- Recruiting
Research Site
Uppsala, 75185
Austria5 sites, 5 recruiting
- Recruiting
Research Site
Graz, 8036
- Recruiting
Research Site
Innsbruck, 6020
- Recruiting
Research Site
Linz, 4020
- Recruiting
Research Site
Vienna, 1020
- Not yet recruiting
Research Site
Vienna, 1090
Netherlands5 sites, 4 recruiting
- Recruiting
Research Site
Hilversum, 1213 XZ
- Withdrawn
Research Site
Hoofddorp, 2134 TM
- Recruiting
Research Site
Maastricht, 6202 AZ
- Recruiting
Research Site
Nijmegen, 6532 SZ
- Recruiting
Research Site
Roosendaal, 4708 AE
Malaysia4 sites
- Withdrawn
Research Site
Batu Caves, 68100
- Withdrawn
Research Site
Kuala Lumpur, 59100
- Withdrawn
Research Site
Kuala Selangor, 62250
- Withdrawn
Research Site
Pulau Pinang, 10450
Peru4 sites
- Withdrawn
Research Site
Lima, 15036
- Withdrawn
Research Site
Lima, LIMA 29
- Withdrawn
Research Site
Lima, Lima 34
- Withdrawn
Research Site
Trujillo, 13008
Chile3 sites
- Withdrawn
Research Site
Concepción, 4070196
- Withdrawn
Research Site
La Serena, 1720430
- Withdrawn
Research Site
Temuco, 4781156
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).
Read the detailed description
Approximately, 700 adult participants with localised/locally advanced prostate cancer will be randomized in a 1:1 ratio to receive saruparib or placebo with ADT (+ abiraterone) in one of the following two cohorts:
Cohort A: 400 adult participants with newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer who have received primary RT and are receiving continuous ADT, and participants with high-risk biochemical recurrence (BCR) [including prostate-specific antigen (PSA) persistence] following a radical prostatectomy who have received salvage RT are receiving continuous ADT.
Cohort B: 300 adult participants with newly diagnosed very high-risk (locally advanced) prostate cancer who have received primary RT and who are receiving continuous ADT and abiraterone.
All participants will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of experts will be convened to confirm the safety and efficacy of Saruparib + ADT (+ abiraterone).
- Conditions
- Prostate Cancer
- Being tested
- Saruparib, Placebo, Abiraterone + Prednisolone/Prednisone, Androgen Deprivation Therapy (ADT)
- Keywords
- Localised/locally advanced prostate cancer, High-risk biochemical recurrence (BCR), Poly (ADP-ribose) polymerase, Radiation therapy or radiotherapy, Breast cancer gene (BRCA) mutation
- 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
Saruparib will be administered orally.
PlaceboDrug
Matching placebo to saruparib will be administered orally.
Abiraterone + Prednisolone/PrednisoneDrug
Abiraterone will be administered orally in combination with prednisone/prednisolone.
Androgen Deprivation Therapy (ADT)Drug
Standard of care ADT will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Saruparib (AZD5305) + Physician's Choice ADT | Experimental | Participants will receive saruparib along with ADT. Receives: Drug: Saruparib; Drug: Androgen Deprivation Therapy (ADT) |
| Cohort A: Placebo + Physician's Choice ADT | Placebo comparator | Participants will receive matching placebo to saruparib along with ADT. Receives: Drug: Placebo; Drug: Androgen Deprivation Therapy (ADT) |
| Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) | Experimental | Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT. Receives: Drug: Saruparib; Drug: Abiraterone + Prednisolone/Prednisone; Drug: Androgen Deprivation Therapy (ADT) |
| Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) | Placebo comparator | Participants will receive matching placebo to saruparib, abiraterone and prednisolone/prednisone along with ADT. Receives: Drug: Placebo; Drug: Abiraterone + Prednisolone/Prednisone; Drug: Androgen Deprivation Therapy (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastasis-free survival (MFS)
MFS is defined as the time from randomisation until the date of first appearance of distant metastases, confirmed by standard clinical imaging [computed tomography (CT)/ magnetic resonance imaging (MRI) and bone scan, or prostate-specific membrane antigen-positron emission tomography (PSMA-PET)], as assessed by blinded independent central review (BICR) or death due to any cause.
Measured: Up to approximately 93 months
Secondary outcomes (14)
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: Up to approximately 11 years
MFS (CT/MRI and bone scan)
MFS is defined as the time from randomisation until the date of distant metastases, confirmed by conventional imaging (CT/MRI and bone scan), or death due to any cause.
Measured: Up to approximately 93 months
MFS (PSMA-PET)
MFS is defined as the time from randomisation until the date of distant metastases, confirmed by PSMA-PET imaging or death due to any cause.
Measured: Up to approximately 93 months
MFS (standard clinical imaging)
MFS is defined as the time from randomisation until the date of distant metastases, confirmed by standard clinical imaging (CT/MRI and bone scan or PSMA-PET), histology, or death due to any cause.
Measured: Up to approximately 93 months
Time from randomisation to Progression Free Survival 2 (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 prostate-specific antigen (PSA) progression] after initiation of first subsequent systemic treatment following the initial investigator-assessed progression or death. The date of second progression will be investigator assessed according to local standard clinical practice.
Measured: Up to approximately 93 months
Time to biochemical recurrence
Time to biochemical recurrence is defined as the time from randomisation to biochemical recurrence per Phoenix criteria.
Measured: Up to approximately 93 months
Prostate cancer-specific survival (PCSS)
PCSS is defined as the time from randomisation until the date of death due to the underlying prostate cancer.
Measured: Up to approximately 11 years
Time to deterioration in urinary symptoms (TTDUS)
TTDUS is defined as the time from randomisation to deterioration in EORTC-QLQ-PR25 (US) subscale scores.
Measured: Up to approximately 93 months
Time to deterioration in physical function (TTDPF)
TTDPF is defined as the time from randomisation to deterioration in EORTC-QLQ-C30 Physical Function subscale scores.
Measured: Up to approximately 93 months
Plasma concentrations of saruparib
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).
Measured: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Area under the curve (AUC)
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).
Measured: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Maximum observed concentration (Cmax)
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).
Measured: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Time to Cmax (Tmax)
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety).
Measured: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Number of participants with adverse events (AEs)
To assess the safety and tolerability of saruparib administered in combination with ADT alone (Cohort A) and in combination with ADT + abiraterone (Cohort B).
Measured: Up to approximately 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start6 Aug 2025
- Primary completion31 Mar 2033 (estimated)
- Study completion30 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952803
- Sponsor's protocol ID
- D9727C00001
- Other IDs
- 2024-513586-39
- Acronym
- EvoPAR-PR02
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2025
- Last updated
- 14 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).
- ClinicalTrials.gov ID
- NCT06952803
- Acronym / sponsor ID
- EvoPAR-PR02 / D9727C00001
- Conditions
- Prostate Cancer
- Keywords
- Localised/locally advanced prostate cancer, High-risk biochemical recurrence (BCR), Poly (ADP-ribose) polymerase, Radiation therapy or radiotherapy, Breast cancer gene (BRCA) mutation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 31 Mar 2033 (estimated)
- Study completion
- 30 Apr 2036 (estimated)
- First posted
- 1 May 2025 (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.
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).
Detailed description
Approximately, 700 adult participants with localised/locally advanced prostate cancer will be randomized in a 1:1 ratio to receive saruparib or placebo with ADT (+ abiraterone) in one of the following two cohorts:
Cohort A: 400 adult participants with newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer who have received primary RT and are receiving continuous ADT, and participants with high-risk biochemical recurrence (BCR) [including prostate-specific antigen (PSA) persistence] following a radical prostatectomy who have received salvage RT are receiving continuous ADT.
Cohort B: 300 adult participants with newly diagnosed very high-risk (locally advanced) prostate cancer who have received primary RT and who are receiving continuous ADT and abiraterone.
All participants will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of experts will be convened to confirm the safety and efficacy of Saruparib + ADT (+ abiraterone).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Saruparib (AZD5305) + Physician's Choice ADT | Experimental | Drug: Saruparib, Drug: Androgen Deprivation Therapy (ADT)Participants will receive saruparib along with ADT. |
| Cohort A: Placebo + Physician's Choice ADT | Placebo comparator | Drug: Placebo, Drug: Androgen Deprivation Therapy (ADT)Participants will receive matching placebo to saruparib along with ADT. |
| Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) | Experimental | Drug: Saruparib, Drug: Abiraterone + Prednisolone/Prednisone, Drug: Androgen Deprivation Therapy (ADT)Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT. |
| Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) | Placebo comparator | Drug: Placebo, Drug: Abiraterone + Prednisolone/Prednisone, Drug: Androgen Deprivation Therapy (ADT)Participants will receive matching placebo to saruparib, abiraterone and prednisolone/prednisone along with ADT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male participants with a histologically documented diagnosis of prostate adenocarcinoma.
- Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.
- Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.
- Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.
- Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
Key exclusion criteria (15 listed)
- Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Participants with any known predisposition to bleeding [e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy].
- Any history of persisting (> 2 weeks) severe cytopenia due to any cause.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib and/or abiraterone.
- 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: AZD5305Saruparib will be administered orally. | Drug | Cohort A: Saruparib (AZD5305) + Physician's Choice ADT, Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) |
| PlaceboMatching placebo to saruparib will be administered orally. | Drug | Cohort A: Placebo + Physician's Choice ADT, Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) |
| Abiraterone + Prednisolone/PrednisoneAbiraterone will be administered orally in combination with prednisone/prednisolone. | Drug | Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone), Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) |
| Androgen Deprivation Therapy (ADT)Standard of care ADT will be administered. | Drug | Cohort A: Placebo + Physician's Choice ADT, Cohort A: Saruparib (AZD5305) + Physician's Choice ADT, Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone), Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) |
Primary outcome
Metastasis-free survival (MFS)
Time frame: Up to approximately 93 months
MFS is defined as the time from randomisation until the date of first appearance of distant metastases, confirmed by standard clinical imaging [computed tomography (CT)/ magnetic resonance imaging (MRI) and bone scan, or prostate-specific membrane antigen-positron emission tomography (PSMA-PET)], as assessed by blinded independent central review (BICR) or death due to any cause.
14 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 11 years
MFS (CT/MRI and bone scan)
Time frame: Up to approximately 93 months
MFS (PSMA-PET)
Time frame: Up to approximately 93 months
MFS (standard clinical imaging)
Time frame: Up to approximately 93 months
Time from randomisation to Progression Free Survival 2 (PFS2)
Time frame: Up to approximately 93 months
Time to biochemical recurrence
Time frame: Up to approximately 93 months
Prostate cancer-specific survival (PCSS)
Time frame: Up to approximately 11 years
Time to deterioration in urinary symptoms (TTDUS)
Time frame: Up to approximately 93 months
Time to deterioration in physical function (TTDPF)
Time frame: Up to approximately 93 months
Plasma concentrations of saruparib
Time frame: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Area under the curve (AUC)
Time frame: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Maximum observed concentration (Cmax)
Time frame: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Time to Cmax (Tmax)
Time frame: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
Number of participants with adverse events (AEs)
Time frame: Up to approximately 11 years
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 14 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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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
346 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saruparib, Abiraterone + Prednisolone/Prednisone and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer, run by AstraZeneca at 346 sites in 28 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 13 inclusion and 15 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 14 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 346 sites in United States, China, Germany, France, Italy and 23 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?
Metastasis-free survival (MFS) (time frame: Up to approximately 93 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.