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 (EvoPAR-PR02)

May 18, 2026 updated by: AstraZeneca

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).

Study Overview

Status

Recruiting

Conditions

Prostate Cancer

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

700

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - CABA, Argentina, 1426
    - Not yet recruiting
    - Research Site
  - CABA, Argentina, C1113AAE
    - Not yet recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1419AHL
    - Not yet recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1426
    - Not yet recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1181
    - Not yet recruiting
    - Research Site
  - Cuidad Autónoma de Buenos Aire, Argentina, C1426ANZ
    - Not yet recruiting
    - Research Site
  - Córdoba, Argentina, 5000
    - Not yet recruiting
    - Research Site
  - Córdoba, Argentina, X5008HHW
    - Not yet recruiting
    - Research Site
  - La Plata, Argentina, 1900
    - Not yet recruiting
    - Research Site
  - Pergamino, Argentina, B2700CPM
    - Not yet recruiting
    - Research Site
  - Rosario, Argentina, S2000KZE
    - Not yet recruiting
    - Research Site
  - San Miguel de Tucumán, Argentina, 4000
    - Not yet recruiting
    - Research Site
  - Viedma, Argentina, R8500ACE
    - Not yet recruiting
    - Research Site
Australia
- - Kingswood, Australia, 2747
    - Withdrawn
    - Research Site
  - Murdoch, Australia, 6150
    - Recruiting
    - Research Site
  - Orange, Australia, 2800
    - Recruiting
    - Research Site
  - South Brisbane, Australia, 4101
    - Recruiting
    - Research Site
  - St Leonards, Australia, 2065
    - Recruiting
    - Research Site
  - Waratah, Australia, 2298
    - Recruiting
    - Research Site
  - Woolloongabba, Australia, 4102
    - Recruiting
    - Research Site
Austria
- - Graz, Austria, 8036
    - Recruiting
    - Research Site
  - Innsbruck, Austria, 6020
    - Not yet recruiting
    - Research Site
  - Linz, Austria, 4020
    - Not yet recruiting
    - Research Site
  - Vienna, Austria, 1090
    - Not yet recruiting
    - Research Site
  - Vienna, Austria, 1020
    - Not yet recruiting
    - Research Site
Belgium
- - Brussels, Belgium, 1070
    - Not yet recruiting
    - Research Site
  - Brussels, Belgium, 1200
    - Recruiting
    - Research Site
  - Jette, Belgium, 1090
    - Recruiting
    - Research Site
  - Kortrijk, Belgium, 8500
    - Recruiting
    - Research Site
  - Libramont-Chevigny, Belgium, 6800
    - Not yet recruiting
    - Research Site
  - Roeselare, Belgium, 8800
    - Recruiting
    - Research Site
  - Wilrijk, Belgium, 2610
    - Recruiting
    - Research Site
Brazil
- - Cachoeiro de Itapemirim, Brazil, 29308-014
    - Recruiting
    - Research Site
  - Curitiba, Brazil, 80810-050
    - Recruiting
    - Research Site
  - Curitiba, Brazil
    - Recruiting
    - Research Site
  - Jaú, Brazil, 17210-120
    - Recruiting
    - Research Site
  - Londrina, Brazil, 86015-520
    - Recruiting
    - Research Site
  - Pelotas, Brazil, 96020-080
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-000
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350200
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22775-001
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22.250-905
    - Recruiting
    - Research Site
  - Salvador, Brazil, 41950640
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01246-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01327-001
    - Recruiting
    - Research Site
Canada
- - Toronto, Canada, M4N 3M5
    - Withdrawn
    - Research Site
- Alberta
  - Calgary, Alberta, Canada, T2V 1P9
    - Withdrawn
    - Research Site
- British Columbia
  - Abbotsford British Columbia, British Columbia, Canada, V2S 0C2
    - Withdrawn
    - Research Site
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - Withdrawn
    - Research Site
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Withdrawn
    - Research Site
  - Brampton, Ontario, Canada, L6R 3J7
    - Withdrawn
    - Research Site
  - London, Ontario, Canada, N6A 5A5
    - Withdrawn
    - Research Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 7K9
    - Withdrawn
    - Research Site
Chile
- - Concepción, Chile, 4070196
    - Withdrawn
    - Research Site
  - Temuco, Chile, 4781156
    - Withdrawn
    - Research Site
China
- - Beijing, China, 100020
    - Recruiting
    - Research Site
  - Beijing, China, 100021
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100176
    - Recruiting
    - Research Site
  - Changchun, China, 130012
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410013
    - Not yet recruiting
    - Research Site
  - Chongqing, China, 400016
    - Recruiting
    - Research Site
  - Guangzhou, China, 510280
    - Recruiting
    - Research Site
  - Guangzhou, China, 510080
    - Recruiting
    - Research Site
  - Guangzhou, China, 510060
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510180
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310022
    - Recruiting
    - Research Site
  - Hangzhou, China, 31000
    - Not yet recruiting
    - Research Site
  - Jinan, China, 250021
    - Not yet recruiting
    - Research Site
  - Jinhua, China, 322100
    - Not yet recruiting
    - Research Site
  - Lanzhou, China, 730030
    - Not yet recruiting
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Ningbo, China, 315010
    - Recruiting
    - Research Site
  - Shanghai, China, 200025
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 20032
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110001
    - Recruiting
    - Research Site
  - Shenyang, China, 110042
    - Not yet recruiting
    - Research Site
  - Sichuan, China, 610041
    - Recruiting
    - Research Site
  - Suining, China, 629018
    - Recruiting
    - Research Site
  - Tianjin, China, 300201
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430022
    - Recruiting
    - Research Site
  - Wuhan, China, 430060
    - Recruiting
    - Research Site
  - Wuhu, China, 241000
    - Not yet recruiting
    - Research Site
  - Xiamen, China, 361003
    - Recruiting
    - Research Site
  - Yangzhou, China, 225001
    - Not yet recruiting
    - Research Site
  - Zhuhai, China, 519099
    - Not yet recruiting
    - Research Site
Finland
- - Helsinki, Finland, 00290
    - Recruiting
    - Research Site
  - Helsinki, Finland, FI-00180
    - Recruiting
    - Research Site
  - Kuopio, Finland, 70210
    - Recruiting
    - Research Site
  - Oulu, Finland, 90029
    - Not yet recruiting
    - Research Site
  - Tampere, Finland, FI-33521
    - Recruiting
    - Research Site
  - Turku, Finland, 20520
    - Recruiting
    - Research Site
France
- - Angers, France, 49100
    - Recruiting
    - Research Site
  - Bordeaux, France, 33000
    - Recruiting
    - Research Site
  - Caen, France, 14076
    - Recruiting
    - Research Site
  - Clermont-Ferrand, France, 63011
    - Recruiting
    - Research Site
  - Le Mans, France, 72000
    - Recruiting
    - Research Site
  - Marseille, France, 13273
    - Not yet recruiting
    - Research Site
  - Montpellier, France, 34070
    - Recruiting
    - Research Site
  - Montpellier, France, 34298
    - Recruiting
    - Research Site
  - Nice, France, 06100
    - Recruiting
    - Research Site
  - Nîmes, France, 30029
    - Recruiting
    - Research Site
  - Paris, France, 75020
    - Recruiting
    - Research Site
  - Paris, France, 75970
    - Recruiting
    - Research Site
  - Paris, France, 75674
    - Recruiting
    - Research Site
  - Pierre-Bénite, France, 69310
    - Recruiting
    - Research Site
  - Rennes, France, 35000
    - Not yet recruiting
    - Research Site
  - Saint-Herblain, France, 44805
    - Recruiting
    - Research Site
  - Saint-Priest-en-Jarez, France, 42270
    - Recruiting
    - Research Site
  - Strasbourg, France, 67200
    - Recruiting
    - Research Site
  - Suresnes, France, 92151
    - Recruiting
    - Research Site
  - Tours, France, 37044
    - Recruiting
    - Research Site
  - Vandœuvre-lès-Nancy, France, 54511
    - Recruiting
    - Research Site
  - Villejuif, France, 94805
    - Recruiting
    - Research Site
Germany
- - Augsburg, Germany, 86156
    - Recruiting
    - Research Site
  - Berlin, Germany, 10117
    - Not yet recruiting
    - Research Site
  - Braunschweig, Germany, 38126
    - Recruiting
    - Research Site
  - Cologne, Germany, 50937
    - Recruiting
    - Research Site
  - Dresden, Germany, 1307
    - Recruiting
    - Research Site
  - Duisburg, Germany, 47169
    - Recruiting
    - Research Site
  - Düsseldorf, Germany, 40226
    - Recruiting
    - Research Site
  - Essen, Germany, 45147
    - Recruiting
    - Research Site
  - Giessen, Germany, 35392
    - Recruiting
    - Research Site
  - Göttingen, Germany, 37075
    - Recruiting
    - Research Site
  - Hamburg, Germany, 20246
    - Recruiting
    - Research Site
  - Herne, Germany, 44625
    - Recruiting
    - Research Site
  - Kiel, Germany, 24105
    - Not yet recruiting
    - Research Site
  - Lübeck, Germany, 23538
    - Not yet recruiting
    - Research Site
  - Marburg, Germany, 35043
    - Recruiting
    - Research Site
  - Münster, Germany, 48149
    - Not yet recruiting
    - Research Site
  - Nuremberg, Germany, 90419
    - Recruiting
    - Research Site
  - Nürtingen, Germany, 72622
    - Not yet recruiting
    - Research Site
  - Regensburg, Germany, 93053
    - Not yet recruiting
    - Research Site
  - Schwerin, Germany, 19049
    - Recruiting
    - Research Site
  - Trier, Germany, 54292
    - Recruiting
    - Research Site
  - Ulm, Germany, 89081
    - Not yet recruiting
    - Research Site
  - Würzburg, Germany, 97080
    - Recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1122
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1082
    - Recruiting
    - Research Site
  - Budapest, Hungary, H-1145
    - Withdrawn
    - Research Site
  - Debrecen, Hungary, 4032
    - Recruiting
    - Research Site
  - Gyula, Hungary, 5700
    - Recruiting
    - Research Site
  - Győr, Hungary, 9024
    - Recruiting
    - Research Site
  - Zalaegerszeg, Hungary, 8900
    - Not yet recruiting
    - Research Site
India
- - Ansārinagar, India, 110 029
    - Recruiting
    - Research Site
  - Babgalore, India, 560069
    - Recruiting
    - Research Site
  - Delhi, India, 110085
    - Withdrawn
    - Research Site
  - Hyderabad, India, 500019
    - Recruiting
    - Research Site
  - Kannur, India, 670103
    - Recruiting
    - Research Site
  - Kanpur, India, 208005
    - Not yet recruiting
    - Research Site
  - Mumbai, India, 400012
    - Not yet recruiting
    - Research Site
  - Nagpur, India, 440001
    - Recruiting
    - Research Site
  - Varanasi, India, 221005
    - Not yet recruiting
    - Research Site
Israel
- - Afula, Israel, 18101
    - Recruiting
    - Research Site
  - Beersheba, Israel, 8410101
    - Recruiting
    - Research Site
  - Haifa, Israel, 31096
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 91031
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 9112001
    - Recruiting
    - Research Site
  - Kfar Saba, Israel, 4428164
    - Recruiting
    - Research Site
  - Petah Tikva, Israel, 49100
    - Recruiting
    - Research Site
  - Ramat Gan, Israel, 52621
    - Recruiting
    - Research Site
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Research Site
Italy
- - Arezzo, Italy, 52100
    - Recruiting
    - Research Site
  - Bari, Italy, 70124
    - Recruiting
    - Research Site
  - Bergamo, Italy, 24127
    - Recruiting
    - Research Site
  - Bergamo, Italy, 24125
    - Not yet recruiting
    - Research Site
  - Chieti, Italy, 66100
    - Not yet recruiting
    - Research Site
  - Genoa, Italy, 16132
    - Recruiting
    - Research Site
  - Milan, Italy, 20132
    - Recruiting
    - Research Site
  - Milan, Italy, 20141
    - Recruiting
    - Research Site
  - Milan, Italy, 20133
    - Recruiting
    - Research Site
  - Naples, Italy, 80131
    - Recruiting
    - Research Site
  - Palermo, Italy, 90127
    - Recruiting
    - Research Site
  - Pisa, Italy, 56126
    - Recruiting
    - Research Site
  - Roma, Italy, 00168
    - Recruiting
    - Research Site
  - Roma, Italy, 00144
    - Recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
  - Torino, Italy, 10126
    - Recruiting
    - Research Site
  - Varese, Italy, 21100
    - Recruiting
    - Research Site
  - Verona, Italy, 37134
    - Recruiting
    - Research Site
Japan
- - Bunkyō City, Japan, 113-8431
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Research Site
  - Kamakura-shi, Japan, 247-8533
    - Recruiting
    - Research Site
  - Kawagoe-shi, Japan, 350-8550
    - Recruiting
    - Research Site
  - Kawasaki-shi, Japan, 216-8511
    - Not yet recruiting
    - Research Site
  - Kisarazu-shi, Japan, 292-8535
    - Recruiting
    - Research Site
  - Kumamoto, Japan, 860-8556
    - Not yet recruiting
    - Research Site
  - Kyoto, Japan, 606-8507
    - Not yet recruiting
    - Research Site
  - Maebashi, Japan, 371-8511
    - Recruiting
    - Research Site
  - Miyazaki, Japan, 889-1692
    - Not yet recruiting
    - Research Site
  - Sagamihara-shi, Japan, 252-0375
    - Recruiting
    - Research Site
  - Shimotsuke-shi, Japan, 329-0498
    - Recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
  - Yokohama, Japan, 232-0024
    - Recruiting
    - Research Site
  - Ōta-ku, Japan, 373-8550
    - Recruiting
    - Research Site
Malaysia
- - Batu Caves, Malaysia, 68100
    - Withdrawn
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Withdrawn
    - Research Site
  - Kuala Selangor, Malaysia, 62250
    - Withdrawn
    - Research Site
  - Pulau Pinang, Malaysia, 10450
    - Withdrawn
    - Research Site
Netherlands
- - Hilversum, Netherlands, 1213 XZ
    - Recruiting
    - Research Site
  - Hoofddorp, Netherlands, 2134 TM
    - Not yet recruiting
    - Research Site
  - Maastricht, Netherlands, 6202 AZ
    - Recruiting
    - Research Site
  - Nijmegen, Netherlands, 6532 SZ
    - Recruiting
    - Research Site
  - Roosendaal, Netherlands, 4708 AE
    - Recruiting
    - Research Site
Peru
- - Lima, Peru, 15036
    - Withdrawn
    - Research Site
  - Lima, Peru, LIMA 29
    - Withdrawn
    - Research Site
  - Lima, Peru, Lima 34
    - Withdrawn
    - Research Site
  - Trujillo, Peru, 13008
    - Withdrawn
    - Research Site
Poland
- - Gdynia, Poland, 81-519
    - Not yet recruiting
    - Research Site
  - Gliwice, Poland, 44-101
    - Not yet recruiting
    - Research Site
  - Koszalin, Poland, 75-581
    - Not yet recruiting
    - Research Site
  - Krakow, Poland, 30-727
    - Not yet recruiting
    - Research Site
  - Piotrkow Trybunalski, Poland, 97-300
    - Not yet recruiting
    - Research Site
  - Poznan, Poland, 61-731
    - Not yet recruiting
    - Research Site
  - Rzeszów, Poland, 35-001
    - Not yet recruiting
    - Research Site
  - Warsaw, Poland, 04-073
    - Not yet recruiting
    - Research Site
South Korea
- - Busan, South Korea, 49241
    - Recruiting
    - Research Site
  - Daegu, South Korea, 41404
    - Recruiting
    - Research Site
  - Goyang-si, South Korea, 10408
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 5505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
  - Seoul, South Korea, 3722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06273
    - Recruiting
    - Research Site
Spain
- - Barcelona, Spain, 08041
    - Recruiting
    - Research Site
  - Barcelona, Spain, 8035
    - Recruiting
    - Research Site
  - Girona, Spain, 17007
    - Recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Recruiting
    - Research Site
  - Madrid, Spain, 28046
    - Recruiting
    - Research Site
  - Majadahonda, Spain, 28222
    - Recruiting
    - Research Site
  - Málaga, Spain, 29010
    - Recruiting
    - Research Site
  - Málaga, Spain, 29009
    - Recruiting
    - Research Site
  - Oviedo, Spain, 33011
    - Recruiting
    - Research Site
  - Sabadell, Spain, 08208
    - Recruiting
    - Research Site
  - Santander, Spain, 39008
    - Recruiting
    - Research Site
  - Valencia, Spain, 46014
    - Recruiting
    - Research Site
  - Valencia, Spain, 46009
    - Recruiting
    - Research Site
Sweden
- - Gothenburg, Sweden, 413 45
    - Recruiting
    - Research Site
  - Malmö, Sweden, 205 02
    - Recruiting
    - Research Site
  - Stockholm, Sweden, 141 86
    - Recruiting
    - Research Site
  - Stockholm, Sweden, 112 81
    - Not yet recruiting
    - Research Site
  - Umeå, Sweden, 901 85
    - Recruiting
    - Research Site
  - Uppsala, Sweden, 75185
    - Not yet recruiting
    - Research Site
Taiwan
- - Kaohsiung City, Taiwan, 83301
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 43503
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 704
    - Recruiting
    - Research Site
  - Taipei, Taiwan
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 110
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10055
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10210
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Research Site
  - Muang, Thailand, 50200
    - Recruiting
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  - Pathum Thani, Thailand, 12120
    - Recruiting
    - Research Site
  - Songkhla, Thailand, 90110
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06620
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06010
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06800
    - Not yet recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06520
    - Recruiting
    - Research Site
  - Cordaleo, Turkey (Türkiye), 35575
    - Recruiting
    - Research Site
  - Diyarbakır, Turkey (Türkiye), 21280
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34722
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34098
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34010
    - Recruiting
    - Research Site
  - Izmir, Turkey (Türkiye), 35040
    - Recruiting
    - Research Site
  - Sakarya, Turkey (Türkiye), 54290
    - Recruiting
    - Research Site
  - Şahinbey, Turkey (Türkiye), 27310
    - Recruiting
    - Research Site
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
    - Recruiting
    - Research Site
  - Bristol, United Kingdom, BS2 8ED
    - Recruiting
    - Research Site
  - Cambridge, United Kingdom, CB2 0QQ
    - Recruiting
    - Research Site
  - Edinburgh, United Kingdom, EH4 2XU
    - Recruiting
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  - Exeter, United Kingdom, EX2 5DW
    - Recruiting
    - Research Site
  - Glasgow, United Kingdom, G12 0YN
    - Not yet recruiting
    - Research Site
  - Greater London, United Kingdom, SW3 6JJ
    - Recruiting
    - Research Site
  - Guildford, United Kingdom, GU2 7XX
    - Not yet recruiting
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  - London, United Kingdom, NW3 2QG
    - Recruiting
    - Research Site
  - London, United Kingdom, WC1N 3BG
    - Recruiting
    - Research Site
  - London, United Kingdom, EC1M6BQ
    - Not yet recruiting
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - Research Site
  - Newcastle, United Kingdom, NE7 7DN
    - Withdrawn
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  - Plymouth, United Kingdom, PL6 8DH
    - Recruiting
    - Research Site
  - Preston, United Kingdom, PR2 9HT
    - Not yet recruiting
    - Research Site
  - Romford, United Kingdom, RM7 0AG
    - Recruiting
    - Research Site
United States
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Recruiting
    - Research Site
  - Tucson, Arizona, United States, 85741
    - Not yet recruiting
    - Research Site
- California
  - La Jolla, California, United States, 92037
    - Recruiting
    - Research Site
  - La Jolla, California, United States, 92093
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Research Site
  - San Diego, California, United States, 92123
    - Recruiting
    - Research Site
  - San Luis Obispo, California, United States, 93401
    - Recruiting
    - Research Site
- Colorado
  - Lakewood, Colorado, United States, 80215
    - Recruiting
    - Research Site
- Florida
  - Hialeah, Florida, United States, 33016
    - Recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Research Site
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Research Site
- Georgia
  - Newnan, Georgia, United States, 30265
    - Recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - Not yet recruiting
    - Research Site
  - Chicago Ridge, Illinois, United States, 60415
    - Recruiting
    - Research Site
- Indiana
  - Greenwood, Indiana, United States, 46143
    - Recruiting
    - Research Site
  - Jeffersonville, Indiana, United States, 47130
    - Not yet recruiting
    - Research Site
- Maryland
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - Research Site
  - Towson, Maryland, United States, 21204
    - Recruiting
    - Research Site
- Massachusetts
  - Plymouth, Massachusetts, United States, 02360
    - Recruiting
    - Research Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Research Site
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Research Site
  - Voorhees Township, New Jersey, United States, 08043
    - Recruiting
    - Research Site
- New York
  - New York, New York, United States, 10065
    - Recruiting
    - Research Site
  - Syracuse, New York, United States, 13210
    - Recruiting
    - Research Site
- Ohio
  - Columbus, Ohio, United States, 43230
    - Recruiting
    - Research Site
- Oregon
  - Springfield, Oregon, United States, 97477
    - Recruiting
    - Research Site
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Recruiting
    - Research Site
  - Lancaster, Pennsylvania, United States, 17601
    - Recruiting
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15212
    - Recruiting
    - Research Site
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Recruiting
    - Research Site
- South Carolina
  - Myrtle Beach, South Carolina, United States, 29572
    - Recruiting
    - Research Site
- Tennessee
  - Nashville, Tennessee, United States, 37209
    - Recruiting
    - Research Site
- Texas
  - Austin, Texas, United States, 78745
    - Recruiting
    - Research Site
  - Austin, Texas, United States, 78705
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77074
    - Recruiting
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Research Site
  - Spring, Texas, United States, 77380
    - Recruiting
    - Research Site
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Not yet recruiting
    - Research Site
- Virginia
  - Norfolk, Virginia, United States, 23502
    - Recruiting
    - Research Site
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - Research Site
  - Virginia Beach, Virginia, United States, 23462
    - Recruiting
    - Research Site
- Washington
  - Seattle, Washington, United States, 98109
    - Not yet recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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).
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.

Exclusion Criteria:

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.
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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: Saruparib (AZD5305) + Physician's Choice ADT Participants will receive saruparib along with ADT.	Drug: Saruparib Saruparib will be administered orally. Other Names: AZD5305 Drug: Androgen Deprivation Therapy (ADT) Standard of care ADT will be administered.
Placebo Comparator: Cohort A: Placebo + Physician's Choice ADT Participants will receive matching placebo to saruparib along with ADT.	Drug: Androgen Deprivation Therapy (ADT) Standard of care ADT will be administered. Drug: Placebo Matching placebo to saruparib will be administered orally.
Experimental: Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT.	Drug: Saruparib Saruparib will be administered orally. Other Names: AZD5305 Drug: Androgen Deprivation Therapy (ADT) Standard of care ADT will be administered. Drug: Abiraterone + Prednisolone/Prednisone Abiraterone will be administered orally in combination with prednisone/prednisolone.
Placebo Comparator: Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone) Participants will receive matching placebo to saruparib, abiraterone and prednisolone/prednisone along with ADT.	Drug: Androgen Deprivation Therapy (ADT) Standard of care ADT will be administered. Drug: Placebo Matching placebo to saruparib will be administered orally. Drug: Abiraterone + Prednisolone/Prednisone Abiraterone will be administered orally in combination with prednisone/prednisolone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 93 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: Up to approximately 11 years	OS is defined as the time from randomisation until the date of death due to any cause.	Up to approximately 11 years
MFS (CT/MRI and bone scan) Time Frame: Up to approximately 93 months	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.	Up to approximately 93 months
MFS (PSMA-PET) Time Frame: Up to approximately 93 months	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.	Up to approximately 93 months
MFS (standard clinical imaging) Time Frame: Up to approximately 93 months	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.	Up to approximately 93 months
Time from randomisation to Progression Free Survival 2 (PFS2) Time Frame: Up to approximately 93 months	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.	Up to approximately 93 months
Prostate cancer-specific survival (PCSS) Time Frame: Up to approximately 11 years	PCSS is defined as the time from randomisation until the date of death due to the underlying prostate cancer.	Up to approximately 11 years
Time to deterioration in urinary symptoms (TTDUS) Time Frame: Up to approximately 93 months	TTDUS is defined as the time from randomisation to deterioration in EORTC-QLQ-PR25 (US) subscale scores.	Up to approximately 93 months
Time to deterioration in physical function (TTDPF) Time Frame: Up to approximately 93 months	TTDPF is defined as the time from randomisation to deterioration in EORTC-QLQ-C30 Physical Function subscale scores.	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)	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).	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)	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).	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)	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).	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)	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).	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	To assess the safety and tolerability of saruparib administered in combination with ADT alone (Cohort A) and in combination with ADT + abiraterone (Cohort B).	Up to approximately 11 years
Time to biochemical recurrence Time Frame: Up to approximately 93 months	Time to biochemical recurrence is defined as the time from randomisation to biochemical recurrence per Phoenix criteria.	Up to approximately 93 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Parexel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2025

Primary Completion (Estimated)

March 31, 2033

Study Completion (Estimated)

April 30, 2036

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D9727C00001
2024-513586-39 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Prostate Cancer

Clinical Trials on Saruparib

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Medical Conditions

Drug Interventions

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Conditions

Rare Diseases

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Locations