Saruparib 대 위약을 사용한 전이 자유 생존에 대한 연구 BRCA 돌연변이가있는 고위험 전립선 암을 가진 남성의 표준 RT/ADT에 추가되었습니다. (EvoPAR-PR02)
안드로겐 박탈 요법 (Evopar-Prostate02)을 통해 방사선 치료를받는 BRCAM 국소 고위험 전립선 암 환자에서 무작위, 이중 맹검, 위약 대조, 보조 Saruparib (AZD5305)의 무작위 III 연구.
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).
연구 개요
상태
정황
상세 설명
Approximately, 700 adult participants with localised/locally advanced prostate cancer will be randomized in a 1:1 ratio to receive saruparib or placebo with ADT (+ abiraterone) in one of the following two cohorts:
Cohort A: 400 adult participants with newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer who have received primary RT and are receiving continuous ADT, and participants with high-risk biochemical recurrence (BCR) [including prostate-specific antigen (PSA) persistence] following a radical prostatectomy who have received salvage RT are receiving continuous ADT.
Cohort B: 300 adult participants with newly diagnosed very high-risk (locally advanced) prostate cancer who have received primary RT and who are receiving continuous ADT and abiraterone.
All participants will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of experts will be convened to confirm the safety and efficacy of Saruparib + ADT (+ abiraterone).
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: AstraZeneca Clinical Study Information Center
- 전화번호: 1-877-240-9479
- 이메일: information.center@astrazeneca.com
연구 장소
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Hilversum, 네덜란드, 1213 XZ
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Hoofddorp, 네덜란드, 2134 TM
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Maastricht, 네덜란드, 6202 AZ
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Nijmegen, 네덜란드, 6532 SZ
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Roosendaal, 네덜란드, 4708 AE
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Kaohsiung City, 대만, 83301
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Taichung, 대만, 40705
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Taichung, 대만, 43503
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Tainan, 대만, 704
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Taipei, 대만, 112
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Taipei, 대만, 110
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Taipei, 대만, 10055
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Taoyuan, 대만, 333
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Busan, 대한민국, 49241
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Seoul, 대한민국, 06351
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Babgalore, 인도, 560069
- 모병
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Calicut, 인도, 673601
- 빼는
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Delhi, 인도, 110085
- 빼는
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Hyderabad, 인도, 500019
- 모병
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Kannur, 인도, 670103
- 모병
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Kanpur, 인도, 208005
- 모병
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Mumbai, 인도, 400012
- 모병
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Nagpur, 인도, 440001
- 모병
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Varanasi, 인도, 221005
- 모병
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-
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Bunkyō City, 일본, 113-8431
- 모병
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Fukuoka, 일본, 812-8582
- 모병
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Kamakura-shi, 일본, 247-8533
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Kawagoe-shi, 일본, 350-8550
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Kawasaki-shi, 일본, 216-8511
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Kisarazu-shi, 일본, 292-8535
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Kumamoto, 일본, 860-8556
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Kyoto, 일본, 606-8507
- 아직 모집하지 않음
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Maebashi, 일본, 371-8511
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Miyazaki, 일본, 889-1692
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Sagamihara-shi, 일본, 252-0375
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Shimotsuke-shi, 일본, 329-0498
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Yokohama, 일본, 241-8515
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Yokohama, 일본, 232-0024
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Ōta-ku, 일본, 373-8550
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Beijing, 중국, 100020
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Beijing, 중국, 100021
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Beijing, 중국, 100176
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Changchun, 중국, 130012
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Changsha, 중국, 410013
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Chongqing, 중국, 400016
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Guangzhou, 중국, 510280
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Guangzhou, 중국, 510080
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Guangzhou, 중국, 510060
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Guangzhou, 중국, 510180
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Hangzhou, 중국, 310022
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Hangzhou, 중국, 31000
- 아직 모집하지 않음
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Jinan, 중국, 250021
- 모병
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Jinhua, 중국, 322100
- 모병
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Lanzhou, 중국, 730030
- 빼는
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Nanchang, 중국, 330006
- 모병
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Ningbo, 중국, 315010
- 모병
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Shanghai, 중국, 200025
- 모병
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Shanghai, 중국, 20032
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Shenyang, 중국, 110001
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Shenyang, 중국, 110042
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Sichuan, 중국, 610041
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Suining, 중국, 629018
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Tianjin, 중국, 300201
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Wuhan, 중국, 430022
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Wuhan, 중국, 430060
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Wuhu, 중국, 241000
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Xiamen, 중국, 361003
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Yangzhou, 중국, 225001
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Zhuhai, 중국, 519099
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Concepción, 칠레, 4070196
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La Serena, 칠레, 1720430
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Temuco, 칠레, 4781156
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Toronto, 캐나다, M4N 3M5
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Alberta
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Calgary, Alberta, 캐나다, T2V 1P9
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British Columbia
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Abbotsford British Columbia, British Columbia, 캐나다, V2S 0C2
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Vancouver, British Columbia, 캐나다, V5Z 4E6
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Ontario
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Barrie, Ontario, 캐나다, L4M 6M2
- 빼는
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Brampton, Ontario, 캐나다, L6R 3J7
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London, Ontario, 캐나다, N6A 5A5
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Toronto, Ontario, 캐나다, M5G 2M9
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Quebec
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Chicoutimi, Quebec, 캐나다, G7H 7K9
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Montreal, Quebec, 캐나다, H3T 1E2
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Saskatchewan
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Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- 빼는
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Bangkok, 태국, 10210
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Bangkok, 태국, 10400
- 모병
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Bangkok, 태국, 10700
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Khon Kaen, 태국, 40002
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Muang, 태국, 50200
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Pathum Thani, 태국, 12120
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Songkhla, 태국, 90110
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Ankara, 터키 (Türkiye), 06800
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Ankara, 터키 (Türkiye), 06620
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Ankara, 터키 (Türkiye), 06010
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Ankara, 터키 (Türkiye), 06520
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Cordaleo, 터키 (Türkiye), 35575
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Diyarbakır, 터키 (Türkiye), 21280
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Istanbul, 터키 (Türkiye), 34722
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Istanbul, 터키 (Türkiye), 34098
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Istanbul, 터키 (Türkiye), 34010
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Izmir, 터키 (Türkiye), 35040
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Sakarya, 터키 (Türkiye), 54290
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Seyhan, 터키 (Türkiye), 01130
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Şahinbey, 터키 (Türkiye), 27310
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Lima, 페루, 15036
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Lima, 페루, LIMA 29
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Lima, 페루, Lima 34
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Trujillo, 페루, 13008
- 빼는
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Gdynia, 폴란드, 81-519
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Gliwice, 폴란드, 44-101
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Koszalin, 폴란드, 75-581
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Krakow, 폴란드, 30-727
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Piotrkow Trybunalski, 폴란드, 97-300
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Poznan, 폴란드, 61-731
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Rzeszów, 폴란드, 35-001
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Warsaw, 폴란드, 04-073
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Angers, 프랑스, 49100
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Bordeaux, 프랑스, 33000
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Caen, 프랑스, 14076
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Clermont-Ferrand, 프랑스, 63011
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Le Mans, 프랑스, 72000
- 모병
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Marseille, 프랑스, 13273
- 빼는
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Montpellier, 프랑스, 34070
- 모병
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Montpellier, 프랑스, 34298
- 모병
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Nice, 프랑스, 06100
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Nîmes, 프랑스, 30029
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Paris, 프랑스, 75020
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Paris, 프랑스, 75970
- 모병
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Paris, 프랑스, 75674
- 모병
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Pierre-Bénite, 프랑스, 69310
- 모병
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Rennes, 프랑스, 35000
- 빼는
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Saint-Herblain, 프랑스, 44805
- 모병
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Saint-Priest-en-Jarez, 프랑스, 42270
- 모병
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Strasbourg, 프랑스, 67200
- 모병
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Suresnes, 프랑스, 92151
- 모병
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Tours, 프랑스, 37044
- 모병
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Vandœuvre-lès-Nancy, 프랑스, 54511
- 모병
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Villejuif, 프랑스, 94805
- 모병
- Research Site
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Helsinki, 핀란드, 00290
- 모병
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Helsinki, 핀란드, FI-00180
- 모병
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Kuopio, 핀란드, 70210
- 모병
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Oulu, 핀란드, 90029
- 아직 모집하지 않음
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Tampere, 핀란드, FI-33521
- 모병
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Turku, 핀란드, 20520
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Budapest, 헝가리, 1122
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Budapest, 헝가리, 1082
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Budapest, 헝가리, H-1145
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Debrecen, 헝가리, 4032
- 모병
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Gyula, 헝가리, 5700
- 모병
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Győr, 헝가리, 9024
- 모병
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Zalaegerszeg, 헝가리, 8900
- 모병
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Kingswood, 호주, 2747
- 빼는
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Murdoch, 호주, 6150
- 모병
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Orange, 호주, 2800
- 모병
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South Brisbane, 호주, 4101
- 모병
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St Leonards, 호주, 2065
- 모병
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Waratah, 호주, 2298
- 모병
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Woolloongabba, 호주, 4102
- 모병
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male participants with a histologically documented diagnosis of prostate adenocarcinoma.
- Newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.
- Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.
- Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.
- Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
- Participants required to have a prostate-specific membrane antigen-positron emission tomography (PSMA-PET) following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization.
- Minimum life expectancy of 12 months.
- Adequate organ and bone marrow function as described in study protocol.
- All participants will have received either primary or salvage RT. Participants must be eligible for randomisation within 10 months of initial diagnosis (de novo or BCR). Radiotherapy administered to the prostate (± pelvis) either in the primary or salvage setting must be delivered with curative intent. Use of metastases-directed therapy, as part of the RT radiation plan, is permitted as localised RT treatment for a metastatic lesion(s) outside the pelvis.
- All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.
- Participants must not father children or donate sperm from signing informed consent form (ICF), during the study intervention and for 6 months after the last dose of study intervention.
- Participants must use a condom (with spermicide - where permitted) from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.
Exclusion Criteria:
- Participants with a history of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Participants with any known predisposition to bleeding [e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy].
- Any history of persisting (> 2 weeks) severe cytopenia due to any cause.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib and/or abiraterone.
- History of another primary malignancy, with exceptions.
- Persistent toxicities [Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2] caused by previous anticancer therapy.
- Cardiac criteria, including history of arrhythmia and cardiovascular disease.
- Evidence of active and uncontrolled hepatitis B and/or hepatitis C.
- Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.
- Active tuberculosis infection.
- Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor.
- Prior treatment within 14 days with blood product support or growth factor support.
- Concomitant use of strong inducers and inhibitors of CYP3A4 (applies to saruparib and abiraterone) or herbal supplements within 21 days or at least 5 half-lives (whichever is longer), of randomization.
- Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).
- Participants with a known hypersensitivity to saruparib or any excipients of these products.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Cohort A: Saruparib (AZD5305) + Physician's Choice ADT
Participants will receive saruparib along with ADT. |
Saruparib will be administered orally.
다른 이름들:
Standard of care ADT will be administered. |
|
위약 비교기: Cohort A: Placebo + Physician's Choice ADT
Participants will receive matching placebo to saruparib along with ADT. |
Standard of care ADT will be administered. Matching placebo to saruparib will be administered orally. |
|
실험적: Cohort B: Saruparib (AZD5305) + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
Participants will receive saruparib, abiraterone and prednisolone/prednisone along with ADT. |
Saruparib will be administered orally.
다른 이름들:
Standard of care ADT will be administered. Abiraterone will be administered orally in combination with prednisone/prednisolone. |
|
위약 비교기: Cohort B: Placebo + Physician's Choice ADT + Abiraterone (and prednisone/prednisolone)
Participants will receive matching placebo to saruparib, abiraterone and prednisolone/prednisone along with ADT. |
Standard of care ADT will be administered. Matching placebo to saruparib will be administered orally. Abiraterone will be administered orally in combination with prednisone/prednisolone. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Metastasis-free survival (MFS)
기간: Up to approximately 93 months
|
MFS is defined as the time from randomisation until the date of first appearance of distant metastases, confirmed by standard clinical imaging [computed tomography (CT)/ magnetic resonance imaging (MRI) and bone scan, or prostate-specific membrane antigen-positron emission tomography (PSMA-PET)], as assessed by blinded independent central review (BICR) or death due to any cause. |
Up to approximately 93 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: Up to approximately 11 years
|
OS is defined as the time from randomisation until the date of death due to any cause. |
Up to approximately 11 years
|
|
MFS (CT/MRI and bone scan)
기간: Up to approximately 93 months
|
MFS is defined as the time from randomisation until the date of distant metastases, confirmed by conventional imaging (CT/MRI and bone scan), or death due to any cause. |
Up to approximately 93 months
|
|
MFS (PSMA-PET)
기간: Up to approximately 93 months
|
MFS is defined as the time from randomisation until the date of distant metastases, confirmed by PSMA-PET imaging or death due to any cause. |
Up to approximately 93 months
|
|
MFS (standard clinical imaging)
기간: Up to approximately 93 months
|
MFS is defined as the time from randomisation until the date of distant metastases, confirmed by standard clinical imaging (CT/MRI and bone scan or PSMA-PET), histology, or death due to any cause. |
Up to approximately 93 months
|
|
Time from randomisation to Progression Free Survival 2 (PFS2)
기간: Up to approximately 93 months
|
Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression [defined as radiographic progression, clinical progression, or prostate-specific antigen (PSA) progression] after initiation of first subsequent systemic treatment following the initial investigator-assessed progression or death. The date of second progression will be investigator assessed according to local standard clinical practice. |
Up to approximately 93 months
|
|
Time to biochemical recurrence
기간: Up to approximately 93 months
|
Time to biochemical recurrence is defined as the time from randomisation to biochemical recurrence per Phoenix criteria. |
Up to approximately 93 months
|
|
Prostate cancer-specific survival (PCSS)
기간: Up to approximately 11 years
|
PCSS is defined as the time from randomisation until the date of death due to the underlying prostate cancer. |
Up to approximately 11 years
|
|
Time to deterioration in urinary symptoms (TTDUS)
기간: Up to approximately 93 months
|
TTDUS is defined as the time from randomisation to deterioration in EORTC-QLQ-PR25 (US) subscale scores. |
Up to approximately 93 months
|
|
Time to deterioration in physical function (TTDPF)
기간: Up to approximately 93 months
|
TTDPF is defined as the time from randomisation to deterioration in EORTC-QLQ-C30 Physical Function subscale scores. |
Up to approximately 93 months
|
|
Plasma concentrations of saruparib
기간: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety). |
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
|
Area under the curve (AUC)
기간: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety). |
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
|
Maximum observed concentration (Cmax)
기간: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety). |
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
|
Time to Cmax (Tmax)
기간: Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
To assess the PK of saruparib in plasma either with or without abiraterone and explore the relationship between the PK concentration/parameters and selected endpoints (which may include pharmacodynamic parameters, efficacy, and/or safety). |
Day 1 of Cycle 1, Cycle 3 and Cycle 6 (each cycle is of 28 days)
|
|
Number of participants with adverse events (AEs)
기간: Up to approximately 11 years
|
To assess the safety and tolerability of saruparib administered in combination with ADT alone (Cohort A) and in combination with ADT + abiraterone (Cohort B). |
Up to approximately 11 years
|
공동 작업자 및 조사자
스폰서
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- D9727C00001
- 2024-513586-39 (기타 식별자: EU CT Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 공유 기간
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 공유 액세스 기준
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .