Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents (EvoPAR-PR01)

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Castration-Sensitive Prostate Cancer
• Intervention / Treatment: Drug: Placebo; Drug: Enzalutamide; Drug: Abiraterone Acetate; Drug: Darolutamide; Drug: Saruparib

Detailed Description

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

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

• Study Type: Interventional
• Enrollment (Actual): 1889
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Chermside, Australia, 4032
    • Research Site
  • Darlinghurst, Australia, 2010
    • Research Site
  • Hyde Park, Australia, 4812
    • Research Site
  • Kurralta Park, Australia, 5037
    • Research Site
  • Melbourne, Australia, 3000
    • Research Site
  • South Brisbane, Australia, 4101
    • Research Site
• Austria
  • Graz, Austria, 8036
    • Research Site
  • Innsbruck, Austria, 6020
    • Research Site
  • Krems, Austria, 3500
    • Research Site
  • Linz, Austria, 4020
    • Research Site
  • Vienna, Austria, 1090
    • Research Site
  • Vienna, Austria, 1020
    • Research Site
• Belgium
  • Ghent, Belgium, 9000
    • Research Site
  • Kortrijk, Belgium, 8500
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
• Brazil
  • Curitiba, Brazil, 80810-050
    • Research Site
  • Pelotas, Brazil, 96020-080
    • Research Site
  • Porto Alegre, Brazil, 90035-001
    • Research Site
  • Rio de Janeiro, Brazil, 22775-001
    • Research Site
  • Salvador, Brazil, 41950-640
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Research Site
  • São Paulo, Brazil, 05652000
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  • São Paulo, Brazil, 01323-903
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• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
      • Research Site
    • Calgary, Alberta, Canada, T2N 5G2
      • Research Site
  • British Columbia
    • Abbotsford British Columbia, British Columbia, Canada, V2S 2J4
      • Research Site
    • Abbotsford British Columbia, British Columbia, Canada, V2T 1X8
      • Research Site
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • Research Site
    • Vancouver, British Columbia, Canada, V5Z 1H7
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  • Ontario
    • Kingston, Ontario, Canada, K7L 5P9
      • Research Site
    • Mississauga, Ontario, Canada, L5M 2N1
      • Research Site
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Research Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
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    • Toronto, Ontario, Canada, M4N 3M5
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  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Research Site
    • Greenfield Park, Quebec, Canada, J4V 2H1
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    • Montreal, Quebec, Canada, H4A 3J1
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    • Montreal, Quebec, Canada, H3T 1E2
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    • Montreal, Quebec, Canada, H2X 3E4
      • Research Site
    • Québec, Quebec, Canada, G1J 1Z4
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  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
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• Chile
  • Concepción, Chile, 4070196
    • Research Site
  • La Serena, Chile, 1720430
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  • Santiago, Chile, 7500787
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  • Santiago, Chile, 7520349
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  • Santiago, Chile, 8330032
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  • Santiago, Chile, 8241479
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  • Temuco, Chile, 4781156
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  • Viña del Mar, Chile, 2540488
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• China
  • Beijing, China, 100142
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  • Beijing, China, 100021
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  • Beijing, China, 100034
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  • Beijing, China, 100050
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  • Beijing, China, CN-100730
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  • Changchun, China, 130021
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  • Changsha, China, 410013
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  • Chengdu, China, 610041
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  • Chongqing, China, 400030
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  • Chongqing, China, 400038
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  • Dongguan, China, 523009
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  • Guangzhou, China, 510180
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  • Guilin, China, 541000
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  • Hangzhou, China, 310022
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  • Hangzhou, China, 310009
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  • Harbin, China, 150081
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  • Jiaxing, China, 314001
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  • Jinan, China, 250021
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  • Lanzhou, China, 730030
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  • Nanchang, China, 330029
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  • Nanchang, China, 330000
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  • Nanjing, China, 2100008
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  • Nantong, China, 226361
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  • Ningbo, China, 315010
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  • Shandong, China
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  • Shanghai, China, 200080
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  • Shanghai, China, 200002
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  • Shenyang, China, 110001
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  • Shenyang, China, 110004
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  • Suining, China, 629000
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  • Taiyuan, China, 030000
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  • Tianjin, China, 300211
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  • Wenzhou, China, 325000
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  • Wuhan, China, 430079
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  • Xi'an, China, 710061
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  • Yantai, China, 264000
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  • Zhengzhou, China, 450008
    • Research Site
• France
  • Angers, France, 49055
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  • Bayonne, France, 64109
    • Research Site
  • Bordeaux, France, 33000
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  • Caen, France, 41076
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  • Clermont-Ferrand, France, 63011
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  • Créteil, France, 94000
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  • Lyon, France, 69373
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  • Montpellier, France, 34298
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  • Nice, France, 06100
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  • Nîmes, France, 30029
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  • Paris, France, 75679
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  • Pierre-Bénite, France, 69495
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  • Poitiers, France, 86021
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  • Quimper, France, 29107
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  • Rennes, France, 35033
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  • Strasbourg, France, 67200
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  • Tours, France, 37000
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  • Vandœuvre-lès-Nancy, France, 54519
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• Germany
  • Bergisch Gladbach, Germany, 51465
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  • Berlin, Germany, 10117
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  • Braunschweig, Germany, 38126
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  • Cologne, Germany, 50968
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  • Dresden, Germany, 01307
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  • Duisburg, Germany, 47169
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  • Frankfurt, Germany, 60488
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  • Frankfurt am Main, Germany, 60590
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  • Freiburg im Breisgau, Germany, 79106
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  • Hamburg, Germany, 20246
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  • Heidelberg, Germany, 69120
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  • Herne, Germany, 44625
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  • Homburg, Germany, 66421
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  • Mannheim, Germany, 68167
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  • Marburg, Germany, 35043
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  • Mettmann, Germany, 40822
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  • München, Germany, 81675
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  • Münster, Germany, 48149
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  • Nürtingen, Germany, 72622
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  • Regensburg, Germany, 93053
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  • Trier, Germany, 54292
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  • Tübingen, Germany, 72076
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  • Ulm, Germany, 89081
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• Hungary
  • Budapest, Hungary, 1145
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  • Budapest, Hungary, 1122
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  • Debrecen, Hungary, 4032
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  • Miskolc, Hungary, 3526
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  • Szeged, Hungary, 6725
    • Research Site
• India
  • Bangalore, India, 560027
    • Research Site
  • Calicut, India, 673601
    • Research Site
  • Kanpur, India, 208005
    • Research Site
  • Kolkata, India, 700099
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  • Nagpur, India, 440001
    • Research Site
  • New Delhi, India, 110085
    • Research Site
  • New Delhi, India, 11029
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  • Pune, India, 411004
    • Research Site
  • Vadodara, India, 391760
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  • Varanasi, India, 221005
    • Research Site
• Italy
  • Bari, Italy, 70124
    • Research Site
  • Genoa, Italy, 16132
    • Research Site
  • Meldola, Italy, 47014
    • Research Site
  • Milan, Italy, 20132
    • Research Site
  • Milan, Italy, 20133
    • Research Site
  • Naples, Italy, 80131
    • Research Site
  • Padova, Italy, 35128
    • Research Site
  • Rome, Italy, 00168
    • Research Site
  • Rozzano, Italy, 20089
    • Research Site
  • Terni, Italy, 05100
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  • Trento, Italy, 38100
    • Research Site
• Japan
  • Chiba, Japan, 260-8717
    • Research Site
  • Fukuoka, Japan, 812-8582
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  • Fukuoka, Japan, 811-1347
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  • Hirakata-shi, Japan, 573-1191
    • Research Site
  • Hirosaki-shi, Japan, 036-8563
    • Research Site
  • Kanazawa, Japan, 920-8641
    • Research Site
  • Kashihara-shi, Japan, 634-8522
    • Research Site
  • Kawagoe-shi, Japan, 350-8550
    • Research Site
  • Kisarazu-shi, Japan, 292-8535
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  • Kita-gun, Japan, 761-0793
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  • Kobe, Japan, 650-0047
    • Research Site
  • Kumamoto, Japan, 860-0008
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  • Kyoto, Japan, 606-8507
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  • Maebashi, Japan, 371-8811
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  • Nagano, Japan, 381-8551
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  • Nagasaki, Japan, 852-8501
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  • Nagoya, Japan, 466-8560
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  • Nagoya, Japan, 466-8650
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  • Osaka, Japan, 541-8567
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  • Osakasayama-shi, Japan, 589-8511
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  • Sagamihara-shi, Japan, 252-0375
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  • Sakura-shi, Japan, 285-8741
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  • Sapporo, Japan, 060-8638
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  • Shiwa-gun, Japan, 028-3695
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  • Suita-shi, Japan, 565-0871
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  • Tsu, Japan, 514-8507
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  • Yokohama, Japan, 232-0024
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  • Yufu-shi, Japan, 879-5593
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• Malaysia
  • George Town, Malaysia, 10450
    • Research Site
  • Johor Bahru, Malaysia, 81100
    • Research Site
  • Kota Kinabalu, Malaysia, 88996
    • Research Site
  • Kuala Lumpur, Malaysia, 59100
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  • Kuala Lumpur, Malaysia, 50586
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  • Kuching, Malaysia, 93586
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• Netherlands
  • Amsterdam, Netherlands, 1066 CX
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  • Hilversum, Netherlands, 1213 XZ
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  • Nijmegen, Netherlands, 6525 GA
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• Peru
  • Bellavista, Peru, CALLAO 2
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  • Lima, Peru, LIMA 29
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  • Lima, Peru, 15036
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  • Lima, Peru, 15102
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  • Lima, Peru, 34
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  • Lima, Peru, 15082
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• Poland
  • Bydgoszcz, Poland, 85-796
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  • Koszalin, Poland, 75-581
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  • Poznan, Poland, 61-731
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  • Rzeszów, Poland, 35-001
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  • Warsaw, Poland, 04-073
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  • Wroclaw, Poland, 53-329
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• South Korea
  • Daejeon, South Korea, 35015
    • Research Site
  • Seongnam-si, South Korea, 13620
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  • Seoul, South Korea, 03080
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  • Seoul, South Korea, 03722
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  • Seoul, South Korea, 05505
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  • Seoul, South Korea, 06351
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  • Seoul, South Korea, 06591
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  • Suwon, South Korea, 16247
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• Spain
  • Barcelona, Spain, 08035
    • Research Site
  • Córdoba, Spain, 14004
    • Research Site
  • L'Hospitalet de Llobregat, Spain, 08908
    • Research Site
  • Lugo, Spain, 27003
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28041
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  • Madrid, Spain, 28040
    • Research Site
  • Sabadell, Spain, 08208
    • Research Site
  • Valencia, Spain, 46014
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 80756
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  • Kaohsiung City, Taiwan, 833
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  • Taichung, Taiwan, 40447
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  • Taichung, Taiwan, 43503
    • Research Site
  • Taoyuan, Taiwan, 333
    • Research Site
  • Yung Kang City, Taiwan, 71044
    • Research Site
• Thailand
  • Bangkok, Thailand, 10210
    • Research Site
  • Bangkok, Thailand, 10330
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  • Bangkok, Thailand, 10700
    • Research Site
  • Chiang Mai, Thailand, 50200
    • Research Site
  • Khlong Luang, Thailand, 12120
    • Research Site
  • Songkhla, Thailand, 90110
    • Research Site
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06590
    • Research Site
  • Ankara, Turkey (Türkiye), 06340
    • Research Site
  • Bornova-Izmir, Turkey (Türkiye), 35100
    • Research Site
  • Cordaleo, Turkey (Türkiye), 35575
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  • Fatih-Istanbul, Turkey (Türkiye), 34098
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  • Istanbul, Turkey (Türkiye), 34722
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• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
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  • Birmingham, United Kingdom, B15 2GW
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  • Cambridge, United Kingdom, CB2 0QQ
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  • Glasgow, United Kingdom, G12 0YN
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  • Guildford, United Kingdom, GU2 7XX
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  • London, United Kingdom, EC1A 7BE
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  • London, United Kingdom, W6 8RF
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  • Manchester, United Kingdom, M20 4BX
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  • Newcastle upon Tyne, United Kingdom, NE7 7AF
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  • Oxford, United Kingdom, OX3 7LE
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  • Plymouth, United Kingdom, PL6 8DH
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  • Preston, United Kingdom, PR2 9HT
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  • Truro, United Kingdom, TR1 3LJ
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• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Research Site
    • Gilbert, Arizona, United States, 85234
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    • Phoenix, Arizona, United States, 85054
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    • Tucson, Arizona, United States, 85741
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  • Arkansas
    • Little Rock, Arkansas, United States, 72205
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    • Springdale, Arkansas, United States, 72762
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  • California
    • Bakersfield, California, United States, 93301
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    • Fountain Valley, California, United States, 92708
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    • Fullerton, California, United States, 92835
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    • Los Angeles, California, United States, 90073
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    • Montebello, California, United States, 90640
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    • San Francisco, California, United States, 94115
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    • Santa Barbara, California, United States, 93105
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    • Santa Monica, California, United States, 90404
      • Research Site
    • Santa Rosa, California, United States, 95403
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  • Colorado
    • Golden, Colorado, United States, 80401
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    • Lakewood, Colorado, United States, 80228
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  • Connecticut
    • New Haven, Connecticut, United States, 06510
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  • Georgia
    • Atlanta, Georgia, United States, 30318
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  • Illinois
    • Glenview, Illinois, United States, 60026
      • Research Site
    • Lake Barrington, Illinois, United States, 60010
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  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Research Site
    • Indianapolis, Indiana, United States, 46202
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  • Kansas
    • Westwood, Kansas, United States, 66205
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  • Louisiana
    • Shreveport, Louisiana, United States, 71103
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  • Maine
    • Scarborough, Maine, United States, 04074
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  • Maryland
    • Baltimore, Maryland, United States, 21201
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    • Baltimore, Maryland, United States, 21287
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    • Bethesda, Maryland, United States, 20817
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    • Towson, Maryland, United States, 21204
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    • Upper Marlboro, Maryland, United States, 20774
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  • Michigan
    • Grand Rapids, Michigan, United States, 49503
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    • Troy, Michigan, United States, 48084
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  • Minnesota
    • Rochester, Minnesota, United States, 55905
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  • Montana
    • Bozeman, Montana, United States, 59715
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  • Nevada
    • Las Vegas, Nevada, United States, 89148
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    • Las Vegas, Nevada, United States, 89102
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  • New Jersey
    • Camden, New Jersey, United States, 08103
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  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
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  • New York
    • East Syracuse, New York, United States, 13057
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    • New Hyde Park, New York, United States, 11042
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    • New York, New York, United States, 10029
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    • Syracuse, New York, United States, 13210
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  • North Carolina
    • Durham, North Carolina, United States, 27710
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  • Ohio
    • Cincinnati, Ohio, United States, 45219
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    • Cincinnati, Ohio, United States, 45212
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    • Cleveland, Ohio, United States, 44111
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    • Cleveland, Ohio, United States, 44124
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    • Columbus, Ohio, United States, 43210
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  • Oregon
    • Portland, Oregon, United States, 97227
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  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004-1017
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    • Philadelphia, Pennsylvania, United States, 19104
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    • Pittsburgh, Pennsylvania, United States, 15212
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  • Rhode Island
    • Providence, Rhode Island, United States, 02903
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  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
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    • North Charleston, South Carolina, United States, 29406
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  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
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  • Tennessee
    • Germantown, Tennessee, United States, 38138
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    • Nashville, Tennessee, United States, 37203
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  • Texas
    • Dallas, Texas, United States, 75231
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    • Houston, Texas, United States, 77025
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    • San Antonio, Texas, United States, 78229
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    • Sugar Land, Texas, United States, 77479
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    • Tyler, Texas, United States, 75702
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    • Wichita Falls, Texas, United States, 76310
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  • Utah
    • Salt Lake City, Utah, United States, 84132
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    • Salt Lake City, Utah, United States, 84106
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    • St. George, Utah, United States, 84790
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  • Virginia
    • Fairfax, Virginia, United States, 22031
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  • Washington
    • Spokane, Washington, United States, 99202
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    • Tacoma, Washington, United States, 98405
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male ≥ 18 years of age.
• Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
• Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
• Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and < 4 months prior to randomisation.
• ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
• Provision of FFPE tumour tissue sample and blood sample (for ctDNA).
• Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.
• Adequate organ and bone marrow function as described in study protocol.
• Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
• Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.

Exclusion Criteria:

• Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no clinical MDS/AML suspicion, no specific screening for MDS/AML (by BM/bone biopsy) is required.
• Participants with any known predisposition to bleeding.
• Any history of persisting (> 2 weeks) severe cytopenia.
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
• History of another primary malignancy, with exceptions.
• Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
• Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
• Cardiac criteria, including history of arrhythmia and cardiovascular disease.
• Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions.
• Prior treatment within 14 days with blood product support or growth factor support.
• Participants who are unevaluable for both bone and soft tissue progression.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 2: Placebo + Physician's Choice NHA; Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)	Drug: Placebo; Oral; Drug: Enzalutamide; Oral; Other Names: Xtandi; Drug: Abiraterone Acetate; Oral; Other Names: Zytiga; Drug: Darolutamide; Oral; Other Names: Nubeqa
Experimental: Arm 1: Saruparib (AZD5305) + Physician's Choice NHA; Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)	Drug: Enzalutamide; Oral; Other Names: Xtandi; Drug: Abiraterone Acetate; Oral; Other Names: Zytiga; Drug: Darolutamide; Oral; Other Names: Nubeqa; Drug: Saruparib; Oral; Other Names: AZD5305

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Progression-Free Survival (rPFS)	rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.	Up to approximately 50 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Number of TEAEs (treatment emergent adverse events), SAEs (serious adverse events), and AEs (adverse events) leading to dose modifications	Up to approximately 50 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Kim Nguyen Chi, MD, BC Cancer, Canada; Principal Investigator: Arun Azad, MD, Peter MacCallum Cancer Centre, Australia

Publications and helpful links

General Publications

• Azad AA, Agarwal N, Armstrong AJ, Hellmis E, Sugimoto M, Urun Y, Xing N, Aregay M, Lima J, Meulendijks D, Chi KN. Saruparib in combination with androgen receptor pathway inhibitors in metastatic hormone-sensitive prostate cancer: EvoPAR-Prostate01. Future Oncol. 2026 Apr;22(10):1153-1163. doi: 10.1080/14796694.2026.2655433. Epub 2026 Apr 14.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): April 30, 2031

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: AZD5305; Saruparib; HRRm; non-HRRm; mCSPC; Prostate Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Androstenes; Androstanes; Abiraterone Acetate; darolutamide; enzalutamide; AZD5305
• Other Study ID Numbers: D9723C00001; 2023-504214-30-00 (Other Identifier: EU CTIS)

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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• 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 de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• 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: No