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

April 25, 2024 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 + 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
    - Recruiting
    - Research Site
  - Hyde Park, Australia, 4812
    - Recruiting
    - Research Site
  - Kurralta Park, Australia, 5037
    - Recruiting
    - Research Site
  - Melbourne, Australia, 3000
    - Recruiting
    - Research Site
  - Randwick, Australia, 2031
    - Recruiting
    - Research Site
  - South Brisbane, Australia, 4101
    - Recruiting
    - Research Site
Austria
- - Graz, Austria, 8036
    - Not yet recruiting
    - Research Site
  - Innsbruck, Austria, 6020
    - Not yet recruiting
    - Research Site
  - Krems an der Donau, Austria, 3500
    - Not yet recruiting
    - Research Site
  - Linz, Austria, 4020
    - Not yet recruiting
    - Research Site
  - Wien, Austria, 1090
    - Not yet recruiting
    - Research Site
  - Wien, Austria, 1020
    - Not yet recruiting
    - Research Site
Belgium
- - Charleroi, Belgium, 6000
    - Not yet recruiting
    - Research Site
  - Gent, Belgium, 9000
    - Not yet recruiting
    - Research Site
  - Kortrijk, Belgium, 8500
    - Not yet recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Not yet recruiting
    - Research Site
Brazil
- - Curitiba, Brazil, 80810-050
    - Not yet recruiting
    - Research Site
  - Pelotas, Brazil, 96020-080
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-001
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22775-001
    - Not yet recruiting
    - Research Site
  - Salvador, Brazil, 41950-640
    - Recruiting
    - Research Site
  - Sao Luis, Brazil, 65060-645
    - Not yet recruiting
    - Research Site
  - Sao Paulo, Brazil, 01323-903
    - Not yet recruiting
    - Research Site
  - Sao Paulo, Brazil, 01246-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05652000
    - Not yet recruiting
    - Research Site
Canada
- - Quebec, Canada, G1J 1Z4
    - Not yet recruiting
    - Research Site
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Not yet recruiting
    - Research Site
  - Calgary, Alberta, Canada, T2V 1P9
    - Not yet recruiting
    - Research Site
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Not yet recruiting
    - Research Site
- British Columbia
  - Abbotsford, British Columbia, Canada, V2T 1X8
    - Recruiting
    - Research Site
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - Not yet recruiting
    - Research Site
  - Vancouver, British Columbia, Canada, V5Z 1H7
    - Not yet recruiting
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - Not yet recruiting
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Not yet recruiting
    - Research Site
- Ontario
  - Kingston, Ontario, Canada, K7L 5P9
    - Recruiting
    - Research Site
  - London, Ontario, Canada, N6A 5W9
    - Not yet recruiting
    - Research Site
  - Mississauga, Ontario, Canada, L5M 2N1
    - Recruiting
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 2P9
    - Not yet recruiting
    - Research Site
  - Ottawa, Ontario, Canada, K1H 8L6
    - Not yet recruiting
    - Research Site
  - Toronto, Ontario, Canada, M4N 3M5
    - Not yet recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5G 2M9
    - Not yet recruiting
    - Research Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 5H6
    - Not yet recruiting
    - Research Site
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Not yet 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
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Not yet recruiting
    - Research Site
Chile
- - Concepcion, Chile, 4070196
    - Not yet recruiting
    - Research Site
  - La Serena, Chile, 1720430
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 8241479
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 8330032
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 7500921
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 7520349
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 7500787
    - Not yet recruiting
    - Research Site
  - Temuco, Chile, 4781156
    - Not yet recruiting
    - Research Site
  - Viña del Mar, Chile, 2540488
    - Not yet recruiting
    - Research Site
China
- - Beijing, China, 100021
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100142
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100050
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100034
    - Not yet recruiting
    - Research Site
  - Beijing, China, CN-100730
    - Not yet recruiting
    - Research Site
  - Changchun, China, 130021
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410013
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610041
    - Not yet recruiting
    - Research Site
  - Chongqing, China, 400038
    - Not yet recruiting
    - Research Site
  - Chongqing, China, 400030
    - Not yet recruiting
    - Research Site
  - Dongguan, China, 523009
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510515
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510180
    - Not yet recruiting
    - Research Site
  - Guilin, China, 541000
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310022
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310009
    - Not yet recruiting
    - Research Site
  - Harbin, China, 150081
    - Not yet recruiting
    - Research Site
  - Jiaxing, China, 314001
    - Not yet recruiting
    - Research Site
  - Jinan, China, 250021
    - Not yet recruiting
    - Research Site
  - Lanzhou, China, 730030
    - Not yet recruiting
    - Research Site
  - Nanchang, China, 330000
    - Not yet recruiting
    - Research Site
  - Nanchang, China, 330029
    - Not yet recruiting
    - Research Site
  - Nanjing, China, 2100008
    - Not yet recruiting
    - Research Site
  - Nantong, China, 226361
    - Not yet recruiting
    - Research Site
  - Ningbo, China, 315010
    - Not yet recruiting
    - Research Site
  - Shandong, China
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200080
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200002
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110001
    - Withdrawn
    - Research Site
  - Shenyang, China, 110004
    - Not yet recruiting
    - Research Site
  - Suining, China, 629000
    - Recruiting
    - Research Site
  - Taiyuan, China, 030000
    - Not yet recruiting
    - Research Site
  - Tianjin, China, 300211
    - Not yet recruiting
    - Research Site
  - WeiFang, China, 261000
    - Withdrawn
    - Research Site
  - Wenzhou, China, 325000
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430079
    - Not yet recruiting
    - Research Site
  - Xi'an, China, 710061
    - Not yet recruiting
    - Research Site
  - Yantai, China, 264000
    - Not yet recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Not yet recruiting
    - Research Site
Finland
- - Helsinki, Finland, 00290
    - Not yet recruiting
    - Research Site
  - Tampere, Finland, 33521
    - Not yet recruiting
    - Research Site
  - Turku, Finland, 20520
    - Not yet recruiting
    - Research Site
France
- - Angers, France, 49055
    - Not yet recruiting
    - Research Site
  - Aurillac Cedex, France, 15002
    - Not yet recruiting
    - Research Site
  - Bayonne, France, 64109
    - Not yet recruiting
    - Research Site
  - Bordeaux Cedex, France, 33000
    - Not yet recruiting
    - Research Site
  - Caen Cedex 5, France, 41076
    - Not yet recruiting
    - Research Site
  - Clermont Ferrand, France, 63011
    - Not yet recruiting
    - Research Site
  - Lyon, France, 69373
    - Not yet recruiting
    - Research Site
  - Montpellier, France, 34298
    - Not yet recruiting
    - Research Site
  - Nice, France, 06100
    - Not yet recruiting
    - Research Site
  - Nimes, France, 30029
    - Not yet recruiting
    - Research Site
  - Pierre Bénite, France, 69495
    - Not yet recruiting
    - Research Site
  - Poitiers Cedex, France, 86021
    - Not yet recruiting
    - Research Site
  - Quimper Cedex, France, 29107
    - Not yet recruiting
    - Research Site
  - Rennes Cedex 9, France, 35033
    - Not yet recruiting
    - Research Site
  - Strasbourg, France, 67033
    - Not yet recruiting
    - Research Site
  - Tours, France, 37000
    - Not yet recruiting
    - Research Site
  - Vandoeuvre les Nancy, France, 54519
    - Not yet recruiting
    - Research Site
Germany
- - Bergisch Gladbach, Germany, 51465
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 10117
    - Not yet recruiting
    - Research Site
  - Bonn, Germany, 53113
    - Withdrawn
    - Research Site
  - Braunschweig, Germany, 38126
    - Not yet recruiting
    - Research Site
  - Dresden, Germany, 01307
    - Not yet recruiting
    - Research Site
  - Duisburg, Germany, 47169
    - Not yet recruiting
    - Research Site
  - Erlangen, Germany, 91054
    - Not yet recruiting
    - Research Site
  - Frankfurt, Germany, 60488
    - Not yet recruiting
    - Research Site
  - Frankfurt am Main, Germany, 60590
    - Not yet recruiting
    - Research Site
  - Freiburg, Germany, 79106
    - Not yet recruiting
    - Research Site
  - Göttingen, Germany, 37075
    - Not yet recruiting
    - Research Site
  - Hamburg, Germany, 20246
    - Not yet recruiting
    - Research Site
  - Heidelberg, Germany, 69120
    - Not yet recruiting
    - Research Site
  - Herne, Germany, 44625
    - Not yet recruiting
    - Research Site
  - Homburg, Germany, 66421
    - Not yet recruiting
    - Research Site
  - Köln, Germany, 50968
    - Not yet recruiting
    - Research Site
  - Magdeburg, Germany, 39120
    - Not yet recruiting
    - Research Site
  - Mannheim, Germany, 68167
    - Not yet recruiting
    - Research Site
  - Marburg, Germany, 35043
    - Not yet recruiting
    - Research Site
  - Mettmann, Germany, 40822
    - Not yet recruiting
    - Research Site
  - München, Germany, 81675
    - Not yet recruiting
    - Research Site
  - Münster, Germany, 48149
    - Not yet recruiting
    - Research Site
  - Nürtingen, Germany, 72622
    - Not yet recruiting
    - Research Site
  - Oldenburg, Germany, 26133
    - Withdrawn
    - Research Site
  - Regensburg, Germany, 93053
    - Not yet recruiting
    - Research Site
  - Stuttgart, Germany, 70176
    - Not yet recruiting
    - Research Site
  - Trier, Germany, 54292
    - Not yet recruiting
    - Research Site
  - Tübingen, Germany, 72076
    - Not yet recruiting
    - Research Site
  - Ulm, Germany, 89081
    - Not yet recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1145
    - Not yet recruiting
    - Research Site
  - Budapest, Hungary, 1125
    - Not yet recruiting
    - Research Site
  - Budapest, Hungary, 1122
    - Not yet recruiting
    - Research Site
  - Budapest, Hungary, 1062
    - Suspended
    - Research Site
  - Debrecen, Hungary, 4032
    - Not yet recruiting
    - Research Site
  - Győr, Hungary, 9024
    - Suspended
    - Research Site
  - Miskolc, Hungary, 3526
    - Not yet recruiting
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Not yet recruiting
    - Research Site
  - Szekszárd, Hungary, 7100
    - Not yet recruiting
    - Research Site
India
- - Bangalore, India, 560027
    - Not yet recruiting
    - Research Site
  - Calicut, India, 673601
    - Not yet recruiting
    - Research Site
  - Delhi, India, 110029
    - Not yet recruiting
    - Research Site
  - Hyderabad, India, 500032
    - Not yet recruiting
    - Research Site
  - JAipur, India, 302022
    - Withdrawn
    - Research Site
  - Kolkata, India, 700160
    - Withdrawn
    - Research Site
  - Kolkata, India, 700099
    - Not yet recruiting
    - Research Site
  - Lucknow, India, 226 005
    - Not yet recruiting
    - Research Site
  - Mohali, India, 160055
    - Withdrawn
    - Research Site
  - Nagpur, India, 440001
    - Not yet recruiting
    - Research Site
  - New Delhi, India, 110085
    - Not yet recruiting
    - Research Site
  - Pune, India, 411004
    - Not yet recruiting
    - Research Site
  - Surat, India, 395002
    - Withdrawn
    - Research Site
  - Vadodara, India, 391760
    - Not yet recruiting
    - Research Site
  - Varanasi, India, 221005
    - Not yet recruiting
    - Research Site
Italy
- - Bari, Italy, 70124
    - Not yet recruiting
    - Research Site
  - Genoa, Italy, 16132
    - Not yet recruiting
    - Research Site
  - Meldola, Italy, 47014
    - Not yet recruiting
    - Research Site
  - Milano, Italy, 20132
    - Not yet recruiting
    - Research Site
  - Milano, Italy, 20133
    - Not yet recruiting
    - Research Site
  - Napoli, Italy, 80131
    - Not yet recruiting
    - Research Site
  - Padova, Italy, 35128
    - Not yet recruiting
    - Research Site
  - Rome, Italy, 00168
    - Not yet recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Not yet recruiting
    - Research Site
  - Terni, Italy, 05100
    - Not yet recruiting
    - Research Site
  - Trento, Italy, 38100
    - Not yet recruiting
    - Research Site
Japan
- - Chiba-shi, Japan, 260-8717
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Not yet recruiting
    - Research Site
  - Fukuoka-shi, Japan, 811-1347
    - Not yet recruiting
    - Research Site
  - Hirakata-shi, Japan, 573-1191
    - Recruiting
    - Research Site
  - Hirosaki-shi, Japan, 036-8563
    - Not yet recruiting
    - Research Site
  - Kanazawa-shi, Japan, 920-8641
    - Not yet recruiting
    - Research Site
  - Kashihara-shi, Japan, 634-8522
    - Not yet recruiting
    - Research Site
  - Kawagoe-shi, Japan, 350-8550
    - Not yet recruiting
    - Research Site
  - Kisarazu-shi, Japan, 292-8535
    - Recruiting
    - Research Site
  - Kita-gun, Japan, 761-0793
    - Recruiting
    - Research Site
  - Kobe-shi, Japan, 650-0047
    - Not yet recruiting
    - Research Site
  - Kumamoto-shi, Japan, 860-0008
    - Recruiting
    - Research Site
  - Maebashi-shi, Japan, 371-8811
    - Not yet recruiting
    - Research Site
  - Nagano-shi, Japan, 381-8551
    - Recruiting
    - Research Site
  - Nagasaki-shi, Japan, 852-8501
    - Recruiting
    - Research Site
  - Nagoya, Japan, 466-8650
    - Not yet recruiting
    - Research Site
  - Nagoya-shi, Japan, 466-8560
    - Not yet recruiting
    - Research Site
  - Osaka-shi, Japan, 541-8567
    - Recruiting
    - Research Site
  - Osakasayama-shi, Japan, 589-8511
    - Recruiting
    - Research Site
  - Sagamihara-shi, Japan, 252-0375
    - Not yet recruiting
    - Research Site
  - Sakura-shi, Japan, 285-8741
    - Recruiting
    - Research Site
  - Sapporo-shi, Japan, 060-8638
    - Recruiting
    - Research Site
  - Shiwa-gun, Japan, 028-3695
    - Not yet recruiting
    - Research Site
  - Suita-shi, Japan, 565-0871
    - Not yet recruiting
    - Research Site
  - Tsu-shi, Japan, 514-8507
    - Recruiting
    - Research Site
  - Yokohama-shi, Japan, 232-0024
    - Recruiting
    - Research Site
  - Yufu-shi, Japan, 879-5593
    - Not yet recruiting
    - Research Site
Korea, Republic of
- - Daejeon, Korea, Republic of, 35015
    - Recruiting
    - Research Site
  - Seongnam-si, Korea, Republic of, 13620
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 03722
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 05505
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 06591
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 06351
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 03080
    - Not yet recruiting
    - Research Site
  - Suwon, Korea, Republic of, 16247
    - Recruiting
    - Research Site
Malaysia
- - George Town, Malaysia, 10450
    - Not yet recruiting
    - Research Site
  - Johor Bahru, Malaysia, 81100
    - Not yet recruiting
    - Research Site
  - Kota Kinabalu, Malaysia, 88996
    - Not yet recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 50586
    - Not yet recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Not yet recruiting
    - Research Site
  - Kuching, Malaysia, 93586
    - Not yet recruiting
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1066 CX
    - Not yet recruiting
    - Research Site
  - Hilversum, Netherlands, 1213 XZ
    - Not yet recruiting
    - Research Site
  - Nijmegen, Netherlands, 6525 GA
    - Not yet recruiting
    - Research Site
Peru
- - Arequipa, Peru, AREQUIPA01
    - Not yet recruiting
    - Research Site
  - Lima, Peru, LIMA 29
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15036
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 34
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15082
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15102
    - Not yet recruiting
    - Research Site
Poland
- - Bydgoszcz, Poland, 85-796
    - Not yet recruiting
    - Research Site
  - Koszalin, Poland, 75-581
    - Not yet recruiting
    - Research Site
  - Poznań, Poland, 61-731
    - Not yet recruiting
    - Research Site
  - Rzeszów, Poland, 35-001
    - Not yet recruiting
    - Research Site
  - Szczecin, Poland, 71-730
    - Not yet recruiting
    - Research Site
  - Warszawa, Poland, 04-073
    - Not yet recruiting
    - Research Site
  - Wrocław, Poland, 53-329
    - Not yet recruiting
    - Research Site
  - Żory, Poland, 44-240
    - Not yet recruiting
    - Research Site
Spain
- - Barcelona, Spain, 08035
    - Not yet recruiting
    - Research Site
  - Córdoba, Spain, 14004
    - Not yet recruiting
    - Research Site
  - L'Hospitalet de Llobregat, Spain, 08908
    - Not yet recruiting
    - Research Site
  - Lugo, Spain, 27003
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28034
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Not yet recruiting
    - Research Site
  - Sabadell, Spain, 08208
    - Not yet recruiting
    - Research Site
  - Valencia, Spain, 46014
    - Not yet recruiting
    - Research Site
Sweden
- - Göteborg, Sweden, 413 45
    - Not yet recruiting
    - Research Site
  - Malmo, Sweden, 20502
    - Not yet recruiting
    - Research Site
  - Solna, Sweden, 171 64
    - Not yet recruiting
    - Research Site
  - Stockholm, Sweden, 118 83
    - Not yet recruiting
    - Research Site
Taiwan
- - Kaohsiung, Taiwan, 80756
    - Recruiting
    - Research Site
  - Kaohsiung city, Taiwan, 833
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Taichung, Taiwan
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
  - Yung Kang City, Taiwan, 71044
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10210
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Chiang Mai, Thailand, 50200
    - Recruiting
    - Research Site
  - Khlong Luang, Thailand, 12120
    - Recruiting
    - Research Site
  - Songkla, Thailand, 90110
    - Recruiting
    - Research Site
Turkey
- - Ankara, Turkey, 06340
    - Recruiting
    - Research Site
  - Ankara, Turkey, 06590
    - Recruiting
    - Research Site
  - Bornova-Izmir, Turkey, 35100
    - Recruiting
    - Research Site
  - Fatih-Istanbul, Turkey, 34098
    - Recruiting
    - Research Site
  - Istanbul, Turkey, 34722
    - Recruiting
    - Research Site
  - Karsiyaka, Turkey, 35575
    - Recruiting
    - Research Site
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
    - Recruiting
    - Research Site
  - Birmingham, United Kingdom, B15 2TH
    - Not yet recruiting
    - Research Site
  - Cambridge, United Kingdom, CB2 0QQ
    - Not yet recruiting
    - Research Site
  - Glasgow, United Kingdom, G12 0YN
    - Not yet recruiting
    - Research Site
  - Guildford, United Kingdom, GU2 7XX
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, W6 8RF
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, EC1A 7BE
    - Not yet recruiting
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Not yet recruiting
    - Research Site
  - Newcastle upon Tyne, United Kingdom, NE7 7AF
    - Not yet recruiting
    - Research Site
  - Oxford, United Kingdom, OX3 7LE
    - Not yet recruiting
    - Research Site
  - Plymouth, United Kingdom, PL6 8DH
    - Recruiting
    - Research Site
  - Preston, United Kingdom, PR2 9HT
    - Not yet recruiting
    - Research Site
  - Swansea, United Kingdom, SA2 8QA
    - Not yet recruiting
    - Research Site
  - Truro, United Kingdom, TR1 3LJ
    - Recruiting
    - Research Site
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Not yet recruiting
    - Research Site
  - Gilbert, Arizona, United States, 85234
    - Not yet recruiting
    - Research Site
  - Phoenix, Arizona, United States, 85054
    - Not yet recruiting
    - Research Site
  - Tucson, Arizona, United States, 85741
    - Not yet recruiting
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Not yet recruiting
    - Research Site
  - Springdale, Arkansas, United States, 72762
    - Recruiting
    - Research Site
- California
  - Bakersfield, California, United States, 93301
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90073
    - Not yet recruiting
    - Research Site
  - Los Angeles, California, United States, 90095
    - Not yet recruiting
    - Research Site
  - Montebello, California, United States, 90640
    - Recruiting
    - Research Site
  - Pasadena, California, United States, 91101
    - Recruiting
    - Research Site
  - Pomona, California, United States, 91767
    - Recruiting
    - Research Site
  - Sacramento, California, United States, 95816
    - Not yet recruiting
    - Research Site
  - San Diego, California, United States, 92123
    - Not yet recruiting
    - Research Site
  - San Francisco, California, United States, 94115
    - Not yet recruiting
    - Research Site
  - Santa Barbara, California, United States, 93105
    - Not yet recruiting
    - Research Site
  - Santa Monica, California, United States, 90404
    - Not yet recruiting
    - Research Site
  - Santa Rosa, California, United States, 95403
    - Recruiting
    - Research Site
- Colorado
  - Golden, Colorado, United States, 80401
    - Not yet recruiting
    - Research Site
  - Lakewood, Colorado, United States, 80228
    - Not yet recruiting
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Not yet recruiting
    - Research Site
  - Norwich, Connecticut, United States, 06360
    - Not yet recruiting
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Withdrawn
    - Research Site
- Florida
  - Jacksonville, Florida, United States, 32224
    - Not yet recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32209
    - Withdrawn
    - Research Site
  - Palm Bay, Florida, United States, 32909
    - Withdrawn
    - Research Site
  - Saint Petersburg, Florida, United States, 33705
    - Not yet recruiting
    - Research Site
  - Tampa, Florida, United States, 33612
    - Withdrawn
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30318
    - Recruiting
    - Research Site
- Illinois
  - Glenview, Illinois, United States, 60026
    - Not yet recruiting
    - Research Site
  - Lake Barrington, Illinois, United States, 60010
    - Recruiting
    - Research Site
- Indiana
  - Fort Wayne, Indiana, United States, 46804
    - Not yet recruiting
    - Research Site
  - Indianapolis, Indiana, United States, 46202
    - Not yet recruiting
    - Research Site
- Iowa
  - Des Moines, Iowa, United States, 50309
    - Recruiting
    - Research Site
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Not yet recruiting
    - Research Site
  - Wichita, Kansas, United States, 67226
    - Not yet recruiting
    - Research Site
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Not yet recruiting
    - Research Site
  - Louisville, Kentucky, United States, 40202
    - Not yet recruiting
    - Research Site
- Louisiana
  - Shreveport, Louisiana, United States, 71103
    - Not yet recruiting
    - Research Site
- Maine
  - Scarborough, Maine, United States, 04074
    - Not yet recruiting
    - Research Site
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Not yet recruiting
    - Research Site
  - Baltimore, Maryland, United States, 21201
    - Not yet recruiting
    - Research Site
  - Baltimore, Maryland, United States, 21287
    - Not yet recruiting
    - Research Site
  - Bethesda, Maryland, United States, 20817
    - Not yet recruiting
    - Research Site
  - Towson, Maryland, United States, 21204
    - Not yet recruiting
    - Research Site
- Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Research Site
  - Troy, Michigan, United States, 48084
    - Not yet recruiting
    - Research Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Not yet recruiting
    - Research Site
- Missouri
  - Columbia, Missouri, United States, 65212
    - Not yet recruiting
    - Research Site
- Montana
  - Billings, Montana, United States, 59102
    - Not yet recruiting
    - Research Site
  - Bozeman, Montana, United States, 59715
    - Not yet recruiting
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - Not yet recruiting
    - Research Site
  - Las Vegas, Nevada, United States, 89148
    - Not yet 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
    - Not yet recruiting
    - Research Site
  - East Brunswick, New Jersey, United States, 08816
    - Not yet recruiting
    - Research Site
  - Voorhees, New Jersey, United States, 08043
    - Not yet recruiting
    - Research Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Not yet recruiting
    - Research Site
  - Albuquerque, New Mexico, United States, 87110
    - Not yet recruiting
    - Research Site
  - Rio Rancho, New Mexico, United States, 87124
    - Not yet recruiting
    - Research Site
- New York
  - Albany, New York, United States, 12206
    - Not yet recruiting
    - Research Site
  - Bronx, New York, United States, 10469
    - Not yet recruiting
    - Research Site
  - New Hyde Park, New York, United States, 11042
    - Not yet recruiting
    - Research Site
  - New York, New York, United States, 10029
    - Not yet recruiting
    - Research Site
  - New York, New York, United States, 10028
    - Not yet recruiting
    - Research Site
  - Shirley, New York, United States, 11967
    - Not yet recruiting
    - Research Site
  - Syracuse, New York, United States, 13210
    - Not yet recruiting
    - Research Site
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Not yet recruiting
    - Research Site
  - Fayetteville, North Carolina, United States, 28303
    - Withdrawn
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Not yet recruiting
    - Research Site
  - Cincinnati, Ohio, United States, 45212
    - Not yet recruiting
    - Research Site
  - Cleveland, Ohio, United States, 44130
    - Recruiting
    - Research Site
  - Cleveland, Ohio, United States, 44124
    - Not yet recruiting
    - Research Site
  - Cleveland, Ohio, United States, 44109
    - Not yet recruiting
    - Research Site
  - Columbus, Ohio, United States, 43201
    - Not yet recruiting
    - Research Site
- Oregon
  - Florence, Oregon, United States, 97439
    - Not yet recruiting
    - Research Site
  - Portland, Oregon, United States, 97239
    - Withdrawn
    - Research Site
  - Portland, Oregon, United States, 97227
    - Not yet recruiting
    - Research Site
- Pennsylvania
  - Bala-Cynwyd, Pennsylvania, United States, 19004-1017
    - Not yet recruiting
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Not yet recruiting
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15212
    - Not yet recruiting
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Withdrawn
    - 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
    - Not yet recruiting
    - Research Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Not yet recruiting
    - Research Site
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Not yet recruiting
    - Research Site
  - Nashville, Tennessee, United States, 37203
    - Not yet recruiting
    - Research Site
- Texas
  - Dallas, Texas, United States, 75246
    - Not yet recruiting
    - 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
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77074
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77025
    - Not yet recruiting
    - Research Site
  - Plano, Texas, United States, 75093
    - Withdrawn
    - Research Site
  - San Antonio, Texas, United States, 78217
    - Not yet recruiting
    - Research Site
  - San Antonio, Texas, United States, 78235
    - Not yet recruiting
    - Research Site
  - Sugar Land, Texas, United States, 77479
    - Not yet recruiting
    - Research Site
  - Tyler, Texas, United States, 75702
    - Not yet recruiting
    - Research Site
  - Wichita Falls, Texas, United States, 76310
    - Not yet recruiting
    - Research Site
- Utah
  - Saint George, Utah, United States, 84790
    - Not yet recruiting
    - Research Site
  - Salt Lake City, Utah, United States, 84132
    - Not yet recruiting
    - Research Site
  - Salt Lake City, Utah, United States, 84106
    - Not yet recruiting
    - Research Site
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Not yet recruiting
    - Research Site
  - Winchester, Virginia, United States, 22601
    - Withdrawn
    - Research Site
- Washington
  - Spokane, Washington, United States, 99202
    - Not yet recruiting
    - Research Site
  - Spokane Valley, Washington, United States, 99216
    - Not yet recruiting
    - Research Site
  - Tacoma, Washington, United States, 98405
    - 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
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 arrythmia 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: Nubequa
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: Nubequa 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 90 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 90 months
Time to First Subsequent Therapy or Death (TFST) Time Frame: up to approximately 90 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 90 months
Symptomatic Skeletal Event-Free Survival (SSE-FS) Time Frame: up to approximately 90 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 90 months
Time to the First Castration-Resistant Event (TTCR) Time Frame: up to approximately 90 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 90 months
Time to Pain Progression (TTPP) Time Frame: up to approximately 90 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 90 months
Time To Deterioration in Urinary Symptoms (TTDUS) Time Frame: up to approximately 90 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 90 months
Time to Deterioration in Fatigue (TTDF) Time Frame: up to approximately 90 months	TTDF is defined as the time from randomisation to deterioration in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7A scores.	up to approximately 90 months
Time to Deterioration in Physical Function (TTDPF) Time Frame: up to approximately 90 months	TTDPF is defined as the time from randomisation to deterioration in PROMIS Physical Function Short Form 8C scores.	up to approximately 90 months
Health-related Quality of Life (HrQoL) Time Frame: up to approximately 90 months	Change from baseline in BPI-SF worst pain score, pain severity, and interference domain scores.	up to approximately 90 months
BRCA and other HRR gene mutation status. Time Frame: at screening		at screening
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 90 months	Samples will be tested by a CDx to certify consistency with assays used in the study.	up to approximately 90 months
PSA (prostate-specific antigen) undetectable rate at 6, 12 months Time Frame: up to approximately 90 months	proportion of participants with undetectable PSA (< 0.2 ng/mL) for those with PSA ≥ 0.2 ng/mL at baseline	up to approximately 90 months
Plasma concentrations of AZD5305 Time Frame: up to approximately 90 months		up to approximately 90 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 90 months	up to approximately 90 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 (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

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

Other Study ID Numbers

D9723C00001
2023-504214-30-00 (Other Identifier: EU CT)

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.

Clinical Trials on Metastatic Castration-Sensitive Prostate Cancer

Myovant Sciences GmbH

Recruiting

Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Metastatic Castration-Resistant Prostate Cancer | Metastatic Castration-Sensitive Prostate Cancer | Non-Metastatic Castration-Resistant Prostate Cancer

United States
Tavanta Therapeutics

Completed

TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer

Metastatic Prostate Cancer | Metastatic Castration-sensitive Prostate Cancer | Metastatic Castration-resistant Prostate Cancer

United States, Spain, United Kingdom, Hungary, France, Poland, Puerto Rico, Sweden
Kindai University
Janssen Pharmaceutical K.K.

Recruiting

Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan (CUARTET)

Metastatic Castration-sensitive Prostate Cancer

Japan
Fudan University

Not yet recruiting

Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment (CHAMPION)

Metastatic Prostate Cancer | Castration-Sensitive Prostate Cancer

China
University of Utah

Terminated

Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer (ACADEMIC)

Stage IV Prostate Cancer | Metastatic Prostatic Adenocarcinoma | Castration-Sensitive Prostate Carcinoma | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer

United States
Pfizer

Completed

Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland

Metastatic Castration Resistant Prostate Cancer (mCRPC) | Metastatic Castration Sensitive Prostate Cancer (mCSPC)

Finland
OHSU Knight Cancer Institute
Oregon Health and Science University; Progenics Pharmaceuticals, Inc.

Not yet recruiting

Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy

Prostate Adenocarcinoma | Castration Resistant Prostate Cancer | Castration Sensitive Prostate Cancer

United States
Janssen Research & Development, LLC

Active, not recruiting

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE)

Metastatic Castration-sensitive Prostate Cancer

United States, Italy, China, Korea, Republic of, Canada, Australia, United Kingdom, Hungary, France, Taiwan, Thailand, Germany, Malaysia, Denmark, Russian Federation, New Zealand, Ukraine, Bulgaria, Israel, Spain, Turkey, Sweden, Cz... and more
Bayer

Completed

A Study Called AWARENESS Using Data From Men in Alberta to Observe Treatment Patterns for Metastatic Castration-sensitive Prostate Cancer

Metastatic Castration-sensitive Prostate Cancer

Canada
National University Hospital, Singapore
National University of Singapore

Active, not recruiting

Effect of Low-dose 500 mg Abiraterone Acetate in Treatment of Metastatic Prostate Cancer Patients

Prostate Cancer | Metastatic Cancer | Castration-resistant Prostate Cancer | Hormone Sensitive Prostate Cancer

Singapore

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
Italfarmaco

Completed

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy

Becker Muscular Dystrophy

Netherlands, Italy
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States
West Penn Allegheny Health System

Completed

Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis

Asthma | Allergic Rhinitis

United States

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)

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

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

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 Metastatic Castration-Sensitive Prostate Cancer

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators