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

March 30, 2026 updated by: AstraZeneca

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

Recruiting

Conditions

Metastatic Castration-Sensitive Prostate Cancer

Intervention / Treatment

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 (Estimated)

1800

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

Australia
- - Chermside, Australia, 4032
    - Recruiting
    - Research Site
  - Darlinghurst, Australia, 2010
    - Terminated
    - Research Site
  - Hyde Park, Australia, 4812
    - Active, not recruiting
    - Research Site
  - Kurralta Park, Australia, 5037
    - Active, not recruiting
    - Research Site
  - Melbourne, Australia, 3000
    - Recruiting
    - Research Site
  - Randwick, Australia, 2031
    - Withdrawn
    - Research Site
  - South Brisbane, Australia, 4101
    - Recruiting
    - Research Site
Austria
- - Graz, Austria, 8036
    - Active, not recruiting
    - Research Site
  - Innsbruck, Austria, 6020
    - Active, not recruiting
    - Research Site
  - Krems, Austria, 3500
    - Recruiting
    - Research Site
  - Linz, Austria, 4020
    - Recruiting
    - Research Site
  - Vienna, Austria, 1090
    - Recruiting
    - Research Site
  - Vienna, Austria, 1020
    - Recruiting
    - Research Site
Belgium
- - Charleroi, Belgium, 6060
    - Withdrawn
    - Research Site
  - Ghent, Belgium, 9000
    - Active, not recruiting
    - Research Site
  - Kortrijk, Belgium, 8500
    - Active, not recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Active, not recruiting
    - Research Site
Brazil
- - Curitiba, Brazil, 80810-050
    - Active, not recruiting
    - Research Site
  - Pelotas, Brazil, 96020-080
    - Active, not recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Withdrawn
    - Research Site
  - Porto Alegre, Brazil, 90035-001
    - Active, not recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22775-001
    - Active, not recruiting
    - Research Site
  - Salvador, Brazil, 41950-640
    - Active, not recruiting
    - Research Site
  - São Luís, Brazil, 65060-645
    - Withdrawn
    - Research Site
  - São Paulo, Brazil, 01246-000
    - Active, not recruiting
    - Research Site
  - São Paulo, Brazil, 05652000
    - Active, not recruiting
    - Research Site
  - São Paulo, Brazil, 01323-903
    - Active, not recruiting
    - Research Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2V 1P9
    - Recruiting
    - Research Site
  - Calgary, Alberta, Canada, T2N 5G2
    - Recruiting
    - Research Site
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Withdrawn
    - Research Site
- British Columbia
  - Abbotsford British Columbia, British Columbia, Canada, V2S 2J4
    - Recruiting
    - Research Site
  - Abbotsford British Columbia, British Columbia, Canada, V2T 1X8
    - Recruiting
    - Research Site
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - Recruiting
    - Research Site
  - Vancouver, British Columbia, Canada, V5Z 1H7
    - Recruiting
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - Withdrawn
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Withdrawn
    - Research Site
- Ontario
  - Kingston, Ontario, Canada, K7L 5P9
    - Recruiting
    - Research Site
  - London, Ontario, Canada, N6A 5W9
    - Withdrawn
    - Research Site
  - Mississauga, Ontario, Canada, L5M 2N1
    - Recruiting
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 2P9
    - Recruiting
    - Research Site
  - Ottawa, Ontario, Canada, K1H 8L6
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M4N 3M5
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - Research Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 5H6
    - Recruiting
    - Research Site
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4A 3J1
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H2X 3E4
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H3T 1E2
    - Recruiting
    - Research Site
  - Québec, Quebec, Canada, G1J 1Z4
    - Recruiting
    - Research Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Recruiting
    - Research Site
Chile
- - Concepción, Chile, 4070196
    - Active, not recruiting
    - Research Site
  - La Serena, Chile, 1720430
    - Active, not recruiting
    - Research Site
  - Santiago, Chile, 7520349
    - Active, not recruiting
    - Research Site
  - Santiago, Chile, 8241479
    - Active, not recruiting
    - Research Site
  - Santiago, Chile, 7500921
    - Withdrawn
    - Research Site
  - Santiago, Chile, 8330032
    - Active, not recruiting
    - Research Site
  - Santiago, Chile, 7500787
    - Active, not recruiting
    - Research Site
  - Temuco, Chile, 4781156
    - Active, not recruiting
    - Research Site
  - Viña del Mar, Chile, 2540488
    - Active, not recruiting
    - Research Site
China
- - Beijing, China, 100142
    - Active, not recruiting
    - Research Site
  - Beijing, China, 100021
    - Active, not recruiting
    - Research Site
  - Beijing, China, CN-100730
    - Active, not recruiting
    - Research Site
  - Beijing, China, 100034
    - Active, not recruiting
    - Research Site
  - Beijing, China, 100050
    - Completed
    - Research Site
  - Changchun, China, 130021
    - Active, not recruiting
    - Research Site
  - Changsha, China, 410013
    - Active, not recruiting
    - Research Site
  - Chengdu, China, 610041
    - Active, not recruiting
    - Research Site
  - Chongqing, China, 400030
    - Active, not recruiting
    - Research Site
  - Chongqing, China, 400038
    - Active, not recruiting
    - Research Site
  - Dongguan, China, 523009
    - Active, not recruiting
    - Research Site
  - Guangzhou, China, 510515
    - Withdrawn
    - Research Site
  - Guangzhou, China, 510180
    - Active, not recruiting
    - Research Site
  - Guilin, China, 541000
    - Active, not recruiting
    - Research Site
  - Hangzhou, China, 310022
    - Active, not recruiting
    - Research Site
  - Hangzhou, China, 310009
    - Active, not recruiting
    - Research Site
  - Harbin, China, 150081
    - Completed
    - Research Site
  - Jiaxing, China, 314001
    - Active, not recruiting
    - Research Site
  - Jinan, China, 250021
    - Active, not recruiting
    - Research Site
  - Lanzhou, China, 730030
    - Active, not recruiting
    - Research Site
  - Nanchang, China, 330000
    - Active, not recruiting
    - Research Site
  - Nanchang, China, 330029
    - Completed
    - Research Site
  - Nanjing, China, 2100008
    - Active, not recruiting
    - Research Site
  - Nantong, China, 226361
    - Active, not recruiting
    - Research Site
  - Ningbo, China, 315010
    - Active, not recruiting
    - Research Site
  - Shandong, China
    - Active, not recruiting
    - Research Site
  - Shanghai, China, 200002
    - Active, not recruiting
    - Research Site
  - Shanghai, China, 200080
    - Active, not recruiting
    - Research Site
  - Shenyang, China, 110001
    - Withdrawn
    - Research Site
  - Shenyang, China, 110001
    - Active, not recruiting
    - Research Site
  - Shenyang, China, 110004
    - Active, not recruiting
    - Research Site
  - Suining, China, 629000
    - Active, not recruiting
    - Research Site
  - Taiyuan, China, 030000
    - Active, not recruiting
    - Research Site
  - Tianjin, China, 300211
    - Active, not recruiting
    - Research Site
  - Weifang, China, 261000
    - Withdrawn
    - Research Site
  - Wenzhou, China, 325000
    - Active, not recruiting
    - Research Site
  - Wuhan, China, 430079
    - Completed
    - Research Site
  - Xi'an, China, 710061
    - Active, not recruiting
    - Research Site
  - Yantai, China, 264000
    - Active, not recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Active, not recruiting
    - Research Site
Finland
- - Helsinki, Finland, 00290
    - Withdrawn
    - Research Site
  - Tampere, Finland, 33521
    - Withdrawn
    - Research Site
  - Turku, Finland, 20520
    - Withdrawn
    - Research Site
France
- - Angers, France, 49055
    - Active, not recruiting
    - Research Site
  - Bayonne, France, 64109
    - Active, not recruiting
    - Research Site
  - Bordeaux, France, 33000
    - Recruiting
    - Research Site
  - Caen, France, 41076
    - Active, not recruiting
    - Research Site
  - Clermont-Ferrand, France, 63011
    - Recruiting
    - Research Site
  - Créteil, France, 94000
    - Active, not recruiting
    - Research Site
  - Lyon, France, 69373
    - Recruiting
    - Research Site
  - Montpellier, France, 34298
    - Recruiting
    - Research Site
  - Nice, France, 06100
    - Recruiting
    - Research Site
  - Nîmes, France, 30029
    - Active, not recruiting
    - Research Site
  - Paris, France, 75679
    - Recruiting
    - Research Site
  - Pierre-Bénite, France, 69495
    - Active, not recruiting
    - Research Site
  - Poitiers, France, 86021
    - Recruiting
    - Research Site
  - Quimper, France, 29107
    - Active, not recruiting
    - Research Site
  - Rennes, France, 35033
    - Active, not recruiting
    - Research Site
  - Strasbourg, France, 67200
    - Active, not recruiting
    - Research Site
  - Tours, France, 37000
    - Active, not recruiting
    - Research Site
  - Vandœuvre-lès-Nancy, France, 54519
    - Active, not recruiting
    - Research Site
Germany
- - Bergisch Gladbach, Germany, 51465
    - Active, not recruiting
    - Research Site
  - Berlin, Germany, 10117
    - Active, not recruiting
    - Research Site
  - Bonn, Germany, 53113
    - Withdrawn
    - Research Site
  - Braunschweig, Germany, 38126
    - Active, not recruiting
    - Research Site
  - Cologne, Germany, 50968
    - Active, not recruiting
    - Research Site
  - Dresden, Germany, 01307
    - Active, not recruiting
    - Research Site
  - Duisburg, Germany, 47169
    - Active, not recruiting
    - Research Site
  - Erlangen, Germany, 91054
    - Withdrawn
    - Research Site
  - Frankfurt, Germany, 60488
    - Active, not recruiting
    - Research Site
  - Frankfurt am Main, Germany, 60590
    - Active, not recruiting
    - Research Site
  - Freiburg im Breisgau, Germany, 79106
    - Active, not recruiting
    - Research Site
  - Göttingen, Germany, 37075
    - Withdrawn
    - Research Site
  - Hamburg, Germany, 20246
    - Recruiting
    - Research Site
  - Heidelberg, Germany, 69120
    - Recruiting
    - Research Site
  - Herne, Germany, 44625
    - Active, not recruiting
    - Research Site
  - Homburg, Germany, 66421
    - Active, not recruiting
    - Research Site
  - Magdeburg, Germany, 39120
    - Withdrawn
    - Research Site
  - Mannheim, Germany, 68167
    - Active, not recruiting
    - Research Site
  - Marburg, Germany, 35043
    - Active, not recruiting
    - Research Site
  - Mettmann, Germany, 40822
    - Active, not recruiting
    - Research Site
  - München, Germany, 81675
    - Active, not recruiting
    - Research Site
  - Münster, Germany, 48149
    - Recruiting
    - Research Site
  - Nürtingen, Germany, 72622
    - Recruiting
    - Research Site
  - Oldenburg, Germany, 26133
    - Withdrawn
    - Research Site
  - Regensburg, Germany, 93053
    - Active, not recruiting
    - Research Site
  - Stuttgart, Germany, 70176
    - Withdrawn
    - Research Site
  - Trier, Germany, 54292
    - Active, not recruiting
    - Research Site
  - Tübingen, Germany, 72076
    - Recruiting
    - Research Site
  - Ulm, Germany, 89081
    - Active, not recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1122
    - Active, not recruiting
    - Research Site
  - Budapest, Hungary, 1145
    - Active, not recruiting
    - Research Site
  - Budapest, Hungary, 1062
    - Withdrawn
    - Research Site
  - Budapest, Hungary, 1125
    - Withdrawn
    - Research Site
  - Debrecen, Hungary, 4032
    - Active, not recruiting
    - Research Site
  - Győr, Hungary, 9024
    - Withdrawn
    - Research Site
  - Miskolc, Hungary, 3526
    - Active, not recruiting
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Withdrawn
    - Research Site
  - Szeged, Hungary, 6725
    - Active, not recruiting
    - Research Site
  - Szekszárd, Hungary, 7100
    - Withdrawn
    - Research Site
India
- - Bangalore, India, 560027
    - Terminated
    - Research Site
  - Calicut, India, 673601
    - Active, not recruiting
    - Research Site
  - Delhi, India, 110029
    - Withdrawn
    - Research Site
  - Hyderabad, India, 500032
    - Withdrawn
    - Research Site
  - Jaipur, India, 302022
    - Withdrawn
    - Research Site
  - Kanpur, India, 208005
    - Active, not recruiting
    - Research Site
  - Kolkata, India, 700160
    - Withdrawn
    - Research Site
  - Kolkata, India, 700099
    - Terminated
    - Research Site
  - Mohali, India, 160055
    - Withdrawn
    - Research Site
  - Nagpur, India, 440001
    - Active, not recruiting
    - Research Site
  - New Delhi, India, 110085
    - Active, not recruiting
    - Research Site
  - New Delhi, India, 11029
    - Active, not recruiting
    - Research Site
  - Pune, India, 411004
    - Active, not recruiting
    - Research Site
  - Surat, India, 395002
    - Withdrawn
    - Research Site
  - Vadodara, India, 391760
    - Active, not recruiting
    - Research Site
  - Varanasi, India, 221005
    - Active, not recruiting
    - Research Site
Italy
- - Bari, Italy, 70124
    - Active, not recruiting
    - Research Site
  - Genoa, Italy, 16132
    - Active, not recruiting
    - Research Site
  - Meldola, Italy, 47014
    - Active, not recruiting
    - Research Site
  - Milan, Italy, 20133
    - Recruiting
    - Research Site
  - Milan, Italy, 20132
    - Active, not recruiting
    - Research Site
  - Naples, Italy, 80131
    - Active, not recruiting
    - Research Site
  - Padova, Italy, 35128
    - Active, not recruiting
    - Research Site
  - Rome, Italy, 00168
    - Active, not recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
  - Terni, Italy, 05100
    - Active, not recruiting
    - Research Site
  - Trento, Italy, 38100
    - Active, not recruiting
    - Research Site
Japan
- - Chiba, Japan, 260-8717
    - Active, not recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Active, not recruiting
    - Research Site
  - Fukuoka, Japan, 811-1347
    - Active, not recruiting
    - Research Site
  - Hirakata-shi, Japan, 573-1191
    - Active, not recruiting
    - Research Site
  - Hirosaki-shi, Japan, 036-8563
    - Active, not recruiting
    - Research Site
  - Kanazawa, Japan, 920-8641
    - Active, not recruiting
    - Research Site
  - Kashihara-shi, Japan, 634-8522
    - Active, not recruiting
    - Research Site
  - Kawagoe-shi, Japan, 350-8550
    - Active, not recruiting
    - Research Site
  - Kisarazu-shi, Japan, 292-8535
    - Active, not recruiting
    - Research Site
  - Kita-gun, Japan, 761-0793
    - Active, not recruiting
    - Research Site
  - Kobe, Japan, 650-0047
    - Active, not recruiting
    - Research Site
  - Kumamoto, Japan, 860-0008
    - Active, not recruiting
    - Research Site
  - Kyoto, Japan, 606-8507
    - Active, not recruiting
    - Research Site
  - Maebashi, Japan, 371-8811
    - Active, not recruiting
    - Research Site
  - Nagano, Japan, 381-8551
    - Active, not recruiting
    - Research Site
  - Nagasaki, Japan, 852-8501
    - Active, not recruiting
    - Research Site
  - Nagoya, Japan, 466-8560
    - Active, not recruiting
    - Research Site
  - Nagoya, Japan, 466-8650
    - Active, not recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Active, not recruiting
    - Research Site
  - Osakasayama-shi, Japan, 589-8511
    - Active, not recruiting
    - Research Site
  - Sagamihara-shi, Japan, 252-0375
    - Active, not recruiting
    - Research Site
  - Sakura-shi, Japan, 285-8741
    - Active, not recruiting
    - Research Site
  - Sapporo, Japan, 060-8638
    - Active, not recruiting
    - Research Site
  - Shiwa-gun, Japan, 028-3695
    - Active, not recruiting
    - Research Site
  - Suita-shi, Japan, 565-0871
    - Active, not recruiting
    - Research Site
  - Tsu, Japan, 514-8507
    - Active, not recruiting
    - Research Site
  - Yokohama, Japan, 232-0024
    - Active, not recruiting
    - Research Site
  - Yufu-shi, Japan, 879-5593
    - Active, not recruiting
    - Research Site
Malaysia
- - George Town, Malaysia, 10450
    - Recruiting
    - Research Site
  - Johor Bahru, Malaysia, 81100
    - Recruiting
    - Research Site
  - Kota Kinabalu, Malaysia, 88996
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 50586
    - Recruiting
    - Research Site
  - Kuching, Malaysia, 93586
    - Recruiting
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1066 CX
    - Active, not recruiting
    - Research Site
  - Hilversum, Netherlands, 1213 XZ
    - Recruiting
    - Research Site
  - Nijmegen, Netherlands, 6525 GA
    - Recruiting
    - Research Site
Peru
- - Arequipa, Peru, AREQUIPA01
    - Withdrawn
    - Research Site
  - Bellavista, Peru, CALLAO 2
    - Active, not recruiting
    - Research Site
  - Lima, Peru, 34
    - Active, not recruiting
    - Research Site
  - Lima, Peru, 15036
    - Active, not recruiting
    - Research Site
  - Lima, Peru, LIMA 29
    - Active, not recruiting
    - Research Site
  - Lima, Peru, 15102
    - Active, not recruiting
    - Research Site
  - Lima, Peru, 15082
    - Terminated
    - Research Site
Poland
- - Bydgoszcz, Poland, 85-796
    - Active, not recruiting
    - Research Site
  - Koszalin, Poland, 75-581
    - Active, not recruiting
    - Research Site
  - Poznan, Poland, 61-731
    - Active, not recruiting
    - Research Site
  - Rzeszów, Poland, 35-001
    - Active, not recruiting
    - Research Site
  - Szczecin, Poland, 71-730
    - Withdrawn
    - Research Site
  - Warsaw, Poland, 04-073
    - Active, not recruiting
    - Research Site
  - Wroclaw, Poland, 53-329
    - Active, not recruiting
    - Research Site
  - Żory, Poland, 44-240
    - Withdrawn
    - Research Site
Puerto Rico
- - San Juan, Puerto Rico, 00927
    - Withdrawn
    - Research Site
South Korea
- - Daejeon, South Korea, 35015
    - Recruiting
    - Research Site
  - Seongnam-si, South Korea, 13620
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 05505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
  - Suwon, South Korea, 16247
    - Recruiting
    - Research Site
Spain
- - Barcelona, Spain, 08035
    - Active, not recruiting
    - Research Site
  - Córdoba, Spain, 14004
    - Active, not recruiting
    - Research Site
  - L'Hospitalet de Llobregat, Spain, 08908
    - Recruiting
    - Research Site
  - Lugo, Spain, 27003
    - Active, not recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Recruiting
    - Research Site
  - Madrid, Spain, 28034
    - Active, not recruiting
    - Research Site
  - Sabadell, Spain, 08208
    - Active, not recruiting
    - Research Site
  - Valencia, Spain, 46014
    - Active, not recruiting
    - Research Site
Sweden
- - Gothenburg, Sweden, 413 45
    - Withdrawn
    - Research Site
  - Malmo, Sweden, 20502
    - Withdrawn
    - Research Site
  - Solna, Sweden, 171 64
    - Withdrawn
    - Research Site
  - Stockholm, Sweden, 118 83
    - Withdrawn
    - Research Site
Taiwan
- - Kaohsiung City, Taiwan, 80756
    - Active, not recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 833
    - Active, not recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Active, not recruiting
    - Research Site
  - Taichung, Taiwan, 43503
    - Active, not recruiting
    - Research Site
  - Taoyuan District, Taiwan, 333
    - Active, not recruiting
    - Research Site
  - Yung Kang City, Taiwan, 71044
    - Active, not recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10210
    - Active, not recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Active, not recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Active, not recruiting
    - Research Site
  - Chiang Mai, Thailand, 50200
    - Active, not recruiting
    - Research Site
  - Khlong Luang, Thailand, 12120
    - Active, not recruiting
    - Research Site
  - Songkhla, Thailand, 90110
    - Active, not recruiting
    - Research Site
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06340
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06590
    - Recruiting
    - Research Site
  - Bornova-Izmir, Turkey (Türkiye), 35100
    - Recruiting
    - Research Site
  - Cordaleo, Turkey (Türkiye), 35575
    - Recruiting
    - Research Site
  - Fatih-Istanbul, Turkey (Türkiye), 34098
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34722
    - Recruiting
    - Research Site
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
    - Active, not recruiting
    - Research Site
  - Birmingham, United Kingdom, B15 2GW
    - Active, not recruiting
    - Research Site
  - Cambridge, United Kingdom, CB2 0QQ
    - Recruiting
    - Research Site
  - Glasgow, United Kingdom, G12 0YN
    - Active, not recruiting
    - Research Site
  - Guildford, United Kingdom, GU2 7XX
    - Recruiting
    - Research Site
  - London, United Kingdom, EC1A 7BE
    - Active, not recruiting
    - Research Site
  - London, United Kingdom, W6 8RF
    - Active, not recruiting
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Active, not recruiting
    - Research Site
  - Newcastle upon Tyne, United Kingdom, NE7 7AF
    - Active, not recruiting
    - Research Site
  - Oxford, United Kingdom, OX3 7LE
    - Active, not recruiting
    - Research Site
  - Plymouth, United Kingdom, PL6 8DH
    - Active, not recruiting
    - Research Site
  - Preston, United Kingdom, PR2 9HT
    - Active, not recruiting
    - Research Site
  - Swansea, United Kingdom, SA2 8QA
    - Withdrawn
    - Research Site
  - Truro, United Kingdom, TR1 3LJ
    - Active, not recruiting
    - Research Site
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Active, not recruiting
    - Research Site
  - Gilbert, Arizona, United States, 85234
    - Completed
    - Research Site
  - Phoenix, Arizona, United States, 85054
    - Active, not recruiting
    - Research Site
  - Tucson, Arizona, United States, 85741
    - Active, not recruiting
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Active, not recruiting
    - Research Site
  - Springdale, Arkansas, United States, 72762
    - Active, not recruiting
    - Research Site
- California
  - Bakersfield, California, United States, 93301
    - Completed
    - Research Site
  - Fountain Valley, California, United States, 92708
    - Active, not recruiting
    - Research Site
  - Fullerton, California, United States, 92835
    - Active, not recruiting
    - Research Site
  - Los Angeles, California, United States, 90095
    - Withdrawn
    - Research Site
  - Los Angeles, California, United States, 90073
    - Active, not recruiting
    - Research Site
  - Montebello, California, United States, 90640
    - Completed
    - Research Site
  - Pasadena, California, United States, 91101
    - Withdrawn
    - Research Site
  - Pomona, California, United States, 91767
    - Withdrawn
    - Research Site
  - Sacramento, California, United States, 95816
    - Withdrawn
    - Research Site
  - San Diego, California, United States, 92123
    - Withdrawn
    - Research Site
  - San Francisco, California, United States, 94115
    - Active, not recruiting
    - Research Site
  - Santa Barbara, California, United States, 93105
    - Active, not recruiting
    - Research Site
  - Santa Monica, California, United States, 90404
    - Active, not recruiting
    - Research Site
  - Santa Rosa, California, United States, 95403
    - Active, not recruiting
    - Research Site
- Colorado
  - Golden, Colorado, United States, 80401
    - Active, not recruiting
    - Research Site
  - Lakewood, Colorado, United States, 80228
    - Active, not recruiting
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Recruiting
    - Research Site
  - Norwich, Connecticut, United States, 06360
    - Withdrawn
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Withdrawn
    - Research Site
- Florida
  - Jacksonville, Florida, United States, 32224
    - Withdrawn
    - Research Site
  - Jacksonville, Florida, United States, 32209
    - Withdrawn
    - Research Site
  - Palm Bay, Florida, United States, 32909
    - Withdrawn
    - Research Site
  - St. Petersburg, Florida, United States, 33705
    - Withdrawn
    - Research Site
  - Tampa, Florida, United States, 33612
    - Withdrawn
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30318
    - Active, not recruiting
    - Research Site
- Illinois
  - Glenview, Illinois, United States, 60026
    - Active, not recruiting
    - Research Site
  - Lake Barrington, Illinois, United States, 60010
    - Active, not recruiting
    - Research Site
- Indiana
  - Fort Wayne, Indiana, United States, 46804
    - Active, not recruiting
    - Research Site
  - Indianapolis, Indiana, United States, 46202
    - Terminated
    - Research Site
- Iowa
  - Des Moines, Iowa, United States, 50309
    - Withdrawn
    - Research Site
- Kansas
  - Westwood, Kansas, United States, 66205
    - Active, not recruiting
    - Research Site
  - Wichita, Kansas, United States, 67226
    - Withdrawn
    - Research Site
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Withdrawn
    - Research Site
  - Louisville, Kentucky, United States, 40202
    - Withdrawn
    - Research Site
- Louisiana
  - Shreveport, Louisiana, United States, 71103
    - Active, not recruiting
    - Research Site
- Maine
  - Scarborough, Maine, United States, 04074
    - Active, not recruiting
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Active, not recruiting
    - Research Site
  - Baltimore, Maryland, United States, 21287
    - Active, not recruiting
    - Research Site
  - Bethesda, Maryland, United States, 20817
    - Active, not recruiting
    - Research Site
  - Towson, Maryland, United States, 21204
    - Active, not recruiting
    - Research Site
  - Upper Marlboro, Maryland, United States, 20774
    - Active, not recruiting
    - Research Site
- Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Active, not recruiting
    - Research Site
  - Troy, Michigan, United States, 48084
    - Active, not recruiting
    - Research Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Active, not recruiting
    - Research Site
- Missouri
  - Columbia, Missouri, United States, 65212
    - Withdrawn
    - Research Site
- Montana
  - Billings, Montana, United States, 59102
    - Withdrawn
    - Research Site
  - Bozeman, Montana, United States, 59715
    - Active, not recruiting
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - Terminated
    - Research Site
  - Las Vegas, Nevada, United States, 89148
    - Active, not recruiting
    - Research Site
- New Jersey
  - Belleville, New Jersey, United States, 07109
    - Withdrawn
    - Research Site
  - Brick, New Jersey, United States, 08724
    - Withdrawn
    - Research Site
  - Camden, New Jersey, United States, 08103
    - Active, not recruiting
    - Research Site
  - East Brunswick, New Jersey, United States, 08816
    - Withdrawn
    - Research Site
  - Voorhees Township, New Jersey, United States, 08043
    - Withdrawn
    - Research Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87110
    - Withdrawn
    - Research Site
  - Albuquerque, New Mexico, United States, 87109
    - Active, not recruiting
    - Research Site
  - Rio Rancho, New Mexico, United States, 87124
    - Withdrawn
    - Research Site
- New York
  - Albany, New York, United States, 12206
    - Withdrawn
    - Research Site
  - East Syracuse, New York, United States, 13057
    - Active, not recruiting
    - Research Site
  - New Hyde Park, New York, United States, 11042
    - Active, not recruiting
    - Research Site
  - New York, New York, United States, 10029
    - Active, not recruiting
    - Research Site
  - New York, New York, United States, 10028
    - Withdrawn
    - Research Site
  - Shirley, New York, United States, 11967
    - Withdrawn
    - Research Site
  - Syracuse, New York, United States, 13210
    - Active, not recruiting
    - Research Site
  - The Bronx, New York, United States, 10469
    - Withdrawn
    - Research Site
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Research Site
  - Fayetteville, North Carolina, United States, 28303
    - Withdrawn
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Active, not recruiting
    - Research Site
  - Cincinnati, Ohio, United States, 45212
    - Active, not recruiting
    - Research Site
  - Cleveland, Ohio, United States, 44109
    - Withdrawn
    - Research Site
  - Cleveland, Ohio, United States, 44130
    - Withdrawn
    - Research Site
  - Cleveland, Ohio, United States, 44111
    - Active, not recruiting
    - Research Site
  - Cleveland, Ohio, United States, 44124
    - Active, not recruiting
    - Research Site
  - Columbus, Ohio, United States, 43210
    - Active, not recruiting
    - Research Site
  - Independence, Ohio, United States, 44131
    - Withdrawn
    - Research Site
  - Wooster, Ohio, United States, 44691
    - Withdrawn
    - Research Site
- Oregon
  - Florence, Oregon, United States, 97439
    - Withdrawn
    - Research Site
  - Portland, Oregon, United States, 97239
    - Withdrawn
    - Research Site
  - Portland, Oregon, United States, 97227
    - Active, not recruiting
    - Research Site
- Pennsylvania
  - Bala-Cynwyd, Pennsylvania, United States, 19004-1017
    - Active, not recruiting
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Active, not recruiting
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Withdrawn
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15212
    - Active, not recruiting
    - Research Site
  - York, Pennsylvania, United States, 17403
    - Withdrawn
    - 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
  - North Charleston, South Carolina, United States, 29406
    - Active, not recruiting
    - Research Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Active, not recruiting
    - Research Site
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Active, not recruiting
    - Research Site
  - Nashville, Tennessee, United States, 37203
    - Active, not recruiting
    - Research Site
- Texas
  - Dallas, Texas, United States, 75231
    - Active, not recruiting
    - Research Site
  - Dallas, Texas, United States, 75246
    - Withdrawn
    - Research Site
  - Denton, Texas, United States, 76201
    - Withdrawn
    - Research Site
  - Flower Mound, Texas, United States, 75028
    - Withdrawn
    - Research Site
  - Grapevine, Texas, United States, 76051
    - Withdrawn
    - Research Site
  - Houston, Texas, United States, 77030
    - Withdrawn
    - Research Site
  - Houston, Texas, United States, 77027
    - Withdrawn
    - Research Site
  - Houston, Texas, United States, 77025
    - Active, not recruiting
    - Research Site
  - Plano, Texas, United States, 75093
    - Withdrawn
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Research Site
  - San Antonio, Texas, United States, 78217
    - Withdrawn
    - Research Site
  - Sugar Land, Texas, United States, 77479
    - Active, not recruiting
    - Research Site
  - Tyler, Texas, United States, 75702
    - Active, not recruiting
    - Research Site
  - Wichita Falls, Texas, United States, 76310
    - Active, not recruiting
    - Research Site
- Utah
  - Salt Lake City, Utah, United States, 84132
    - Recruiting
    - Research Site
  - Salt Lake City, Utah, United States, 84106
    - Active, not recruiting
    - Research Site
  - St. George, Utah, United States, 84790
    - Active, not recruiting
    - Research Site
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Active, not recruiting
    - Research Site
  - Winchester, Virginia, United States, 22601
    - Withdrawn
    - Research Site
- Washington
  - Spokane, Washington, United States, 99202
    - Active, not recruiting
    - Research Site
  - Spokane Valley, Washington, United States, 99216
    - Withdrawn
    - Research Site
  - Tacoma, Washington, United States, 98405
    - Active, not 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 ≥ 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

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
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) Time Frame: Up to approximately 50 months	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) Time Frame: Up to approximately 90 months	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 Frame: Up to approximately 50 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 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) Time Frame: Up to approximately 50 months	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) Time Frame: Up to approximately 50 months	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) Time Frame: Up to approximately 50 months	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) Time Frame: Up to approximately 50 months	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) Time Frame: Up to approximately 50 months	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) Time Frame: Up to approximately 50 months	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) Time Frame: Up to approximately 50 months	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 Time Frame: At screening		At screening
Plasma concentrations of AZD5305 Time Frame: Up to approximately 10 months		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. Time Frame: Up to approximately 50 months	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 Time Frame: Up to approximately 50 months	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 Time Frame: Up to approximately 50 months	Up to approximately 50 months

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

Principal Investigator: Kim Nguyen Chi, MD, BC Cancer, Canada
Principal Investigator: Arun Azad, MD, Peter MacCallum Cancer Centre, Australia

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)

November 21, 2023

Primary Completion (Estimated)

January 11, 2028

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)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

AZD5305; Saruparib; HRRm; non-HRRm; mCSPC; Prostate Cancer

Additional Relevant MeSH Terms

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

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

Other Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

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First Submitted That Met QC Criteria

First Posted (Actual)

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Last Update Submitted That Met QC Criteria

Last Verified

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Plan for Individual participant data (IPD)

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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

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