Trial design and patients
Cancer Center/Cancer, death, Tumor, TALAPRO-2, der, Cancer
TUMOR, DISEASE, POLAND, SOLID TUMOR, DEL, WEST, ADVERSE EVENT, ONCOLOGY, DER, CANCER
TALAPRO-2 (Eligibility criteria included ongoing androgen deprivation therapy; asymptomatic or mildly symptomatic mCRPC with HRR gene alterations; Eastern Cooperative Oncology Group performance status score of 0 or 1; progressive disease; adequate bone marrow function (hemoglobin ≥9 g dlBefore randomization, patients consented to provide solid tumor tissue (de novo or archival) and/or blood-based samples, for prospective assessment of HRR gene alterations (Enrollment of patients with Study treatment continued until radiographic progression, adverse event leading to permanent discontinuation, patient decision to discontinue or death. Treatment could continue after radiographic progression if the investigator determined benefit was still being derived.The trial was conducted in accordance with the International Ethical Guidelines for Biomedical Research Involving Human Subjects, Good Clinical Practice guidelines, the principles of the Declaration of Helsinki and local laws. The protocol and amendments were approved by the institutional review board and independent ethics committee for each site. The following independent ethics committees or Institutional Review Boards provided study approval: Comite de Revision Institucional - Hospital Britanico de Buenos Aires, CABA, Argentina; Comite de Etica ‘Dr. Claude Bernard’, Rosario, Argentina; Comite de Etica en Investigacion - Centro de Educacion Medica e Investigaciones Clinicas ‘Norberto Quirno’ – CEMIC, CABA, Argentina; Comite de Etica en Investigacion de la Fundacion OncoSalud (CEIFOS), Pergamino, Argentina; Comite Independiente De Etica Para Ensayos En Farmacologia Clinica, CABA, Argentina; Comite Institucional de Etica de la Investigacion en Salud (C.I.E.I.S) de la Clinica Universitaria Reina Fabiola, Cordoba, Argentina; Comite Institucional de Etica de Investigacion en Salud del Hospital Privado Centro Medico de Cordoba, Cordoba, Argentina; St Vincent’s Hospital Human Research Ethics Committee, Darlinghurst, Australia; Bellberry Limited, Eastwood, Australia; Commissie Voor Medische Ethiek, Gent, Belgium; Comissao Nacional de Etica em Pesquisa/CONEP, Brasilia, Brazil; Comite de Etica em Pesquisa da Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, Brazil; Comite de Etica em Pesquisa da Universidade do Vale do Taquari – UNIVATES, Lajeado, Brazil; Comite de Etica em Pesquisa do Hospital Mae de Deus, Porto Alegre, Brazil; Comite de Etica em Pesquisa do Instituto D’Or de Pesquisa e Ensino, Rio de Janeiro, Brazil; Comite de Etica em Pesquisa-Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Comite de Etica em Pesquisa da Universidade Regional do Noroeste do Estado do Rio Grande do Sul, Ijui, Brazil; Comite de Etica em Pesquisa - CEP do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP, Sao Paulo, Brazil; Comite de Etica em Pesquisa da Faculdade de Medicina do ABC, Santo Andre, Brazil; Comitê de Ética em Pesquisa do Instituto Nacional de Câncer Jose Alencar Gomes da Silva – INCA, Rio de Janeiro, Brazil; Comite de Etica em Pesquisa do Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao, Porto Alegre, Brazil; Comite de Etica em Pesquisa da Sociedade Beneficente de Senhoras Hospital Sirio Libanes, Sao Paulo, Brazil; Comitê de Ética em Pesquisa do Hospital Alemão Oswaldo Cruz – SP, Sao Paulo, Brazil; Comite de Etica em Pesquisa da Pontificia Universidade Catolica do Rio Grande do Sul-PUC/RS, Porto Alegre, Brazil; Comite d’ethique de la recherche du CHUM, Montreal, Canada; Health Research Ethics Board of Alberta - Cancer Committee, Edmonton, Canada; Ontario Cancer Research Ethics Board, Toronto, Canada; Comite de Etica Cientifico Servicio de Salud Metropolitano Oriente, Santiago, Chile; Comite Etico Cientifico Hospital Gustavo Fricke Servicio de Salud Vina del Mar – Quillota, Vina del Mar, Chile; Comite de Etica Cientifica Servicio Salud Araucania Sur, Temuco, Chile; Ethics Committee of Zhongshan Hospital Fudan University, Shanghai, China; Ethics Committee of The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China; Ethics committee of Zhejiang Cancer Hospital, Hangzhou, China; Ethics Committee of National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Ethics Committee of Chongqing University Cancer Hospital, Chongqing, China; Ethics Committee of Beijing Cancer Hospital, Beijing, China; Ethics Committee of The First Affiliated Hospital of Anhui Medical University, Hefei, China; Medical Ethics Committee of First Affiliated Hospital of Xiamen University, Xiamen, China; Wuxi People’s Hospital Ethics Committee, Wuxi, China; Ethics Committee of Nanjing Drum Tower Hospital, Nanjing, China; Ethics Committee of Shanghai Tenth People’s Hospital, Shanghai, China; Clinical Trial Ethics Committee of Huazhong University of Science and Technology, Wuhan, China; Ethics Committee of Huashan Hospital, Fudan University, Shanghai, China; Ethics Committee of Fudan University Cancer Hospital, Shanghai, China; Ethics Committee of Beijing Hospital, Beijing, China; Ethics Committee of Peking University First Hospital, Beijing, China; Peking University Third Hospital Medical Science Research Ethics Committee, Beijing, China; Ethics Committee for Clinical Trials of Drugs (Medical Apparatus) of Ningbo First Hospital, Ningbo, China; Ethics Committee of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China; West China Hospital of Sichuan University Clinical Trial Ethics Committee, Chengdu, China; EC of Second Affiliated Hospital of Suzhou University, Suzhou, China; Shanghai General Hospital Medical Ethics Committee, Shanghai, China; Ethics Committee of Nanjing First Hospital, Nanjing, China; Clinical Trial Ethics Committee of Huazhong University of Science and Technology, Wuhan, China; Drug and Machinery Clinical trial Branch of EC of The First Affiliated Hospital of Fujian Medical University, Fuzhou, China; Ethics Committee of Yunnan Cancer Hospital, Kunming, China; The First Affiliated Hospital of Nanchang University Ethics Committee, Nanchang, China; Jilin Cancer Hospital Institutional Review Board, Changchun, China; Ethics Committee of The Second Hospital of Tianjin Medical University, Tianjin, China; Ethics Committee of Zhejiang Provincial People’s Hospital, Hangzhou, China; Ethics Committee of The Fifth People’s Hospital of Shanghai, Fudan University, Shanghai, China; Ethics Committee of Nantong Tumor Hospital, Nantong, China; Medical Ethics Committee of The First People’s Hospital of Lianyungang, Lianyungang, China; The Clinical Trial Ethics Committee of The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China; Eticka komise Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, Usti and Labem, Czech Republic; Eticka komise pro multicentricke klinicke hodnoceni Fakultni nemocnice Kralovske Vinohrady, Praha, Czech Republic; Eticka komise Fakultni Nemocnice Ostrava, Ostrava-Poruba, Czech Republic; Eticka komise Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czech Republic; Helsingin ja Uudenmaan sairaanhoitopiiri, Helsinki, Finland; Comite De Protection Des Personnes (CPP) Sud-Ouest Et Outre-Mer III, Bordeaux, France; Ethikkommission der Aerztekammer Hamburg, Hamburg, Germany; Egészségügyi Tudományos Tanács Klinikai Farmakológiai Etikai Bizottsága, Budapest, Hungary; Bnai Zion Medical Center Helsinki Committee, Haifa, Israel; Rambam Health Care Campus Helsinki Committee, Haifa, Israel; Tel Aviv Sourasky Medical Center Helsinki Committee, Tel Aviv, Israel; Rabin Medical Center Helsinki Committee, Petah Tikva, Israel; Shaare Zedek Medical Center Helsinki Committee, Jerusalem, Israel; Comitato Etico Azienda Ospedaliero Universitaria San Luigi Gonzaga, Orbassano, Italy; Comitato Etico Val Padana, Cremona, Italy; Comitato Etico Regionale (CER) dell’Umbria, Perugia, Italy; Comitato Etico Cardarelli-Santobono, Napoli, Italy; Comitato Etico Per Le Sperimentazioni Cliniche Dell’Azienda Provinciale Per I Servizi Sanitari, Trento, Italy; Comitato Etico della Romagna (CEROM), Meldola, Italy; Comitato Etico di Brescia, Brescia, Italy; Comitato Etico di Area Vasta Emilia Centro, Bologna, Italy; Comitato Etico IRCCS Pascale, Napoli, Italy; National Hospital Organization Central Review Board, Meguro-ku, Tokyo, Japan; National Cancer Center Institutional Review Board, Chuo-ku, Tokyo, Japan; Kindai University Hospital Institutional Review Board, Osakasayama, Japan; Yokohama City University Medical Center Institutional Review Board, Yokohama, Japan; Keio University Hospital Institutional Review Board, Shinjuku-ku, Tokyo, Japan; Nagoya University Hospital Institutional Review Board, Nagoya, Japan; Hokkaido University Hospital Institutional Review Board, Sapporo, Japan; Tokushima University Hospital Institutional Review Board, Tokushima, Japan; Chiba Cancer Center Institutional Review Board, Chiba, Japan; Hirosaki University School of Medicine & Hospital Institutional Review Board, Hirosaki, Japan; Yamagata Prefectural Central Hospital Institutional Review Board, Yamagata, Japan; Yokosuka Kyosai Hospital Institutional Review Board, Yokosuka, Japan; Hamamatsu University School of Medicine, University hospital Institutional Review Board, Hamamatsu, Japan; Osaka International Cancer Institute Institutional Review Board, Osaka-shi, Japan; Osaka University Hospital Institutional Review Board, Suita, Japan; Kanazawa University Hospital Institutional Review Board, Kanazawa, Japan; Kagoshima University Hospital Institutional Review Board, Kagoshima, Japan; Yamagata University Hospital Institutional Review Board, Yamagata, Japan; Kyungpook National University Chilgok Hospital Institutional Review Board, Daegu, Republic of Korea; Samsung Medical Center Institutional Review Board, Seoul, Republic of Korea; Asan Medical Center Institutional Review Board, Seoul, Republic of Korea; Severance Hospital, Yonsei University Health System Institutional Review Board, Seoul, Republic of Korea; Pusan National University Hospital Institutional Review Board, Busan, Republic of Korea; Seoul National University Hospital Institutional Review Board, Seoul, Republic of Korea; National Cancer Center Institutional Review Board, Goyang-si, Republic of Korea; The Catholic University of Korea Seoul St. Mary’s Hospital Institutional Review Board, Seoul, Republic of Korea; Health and Disability Ethics Committee, Wellington, New Zealand; REK Sor-Ost, Oslo, Norway; Comite Institucional de Etica en Investigacion del INEN, Lima, Peru; Comite Institucional de Bioetica de Via Libre, Lima, Peru; Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Gdansku, Gdansk, Poland; Comissao de Etica para a Investigacao Clinica, Lisboa, Portugal; University of the Witwatersrand Human Research Ethics Committee (Medical), Johannesburg, South Africa; CEIm del Hospital Universitari Vall d’Hebron, Barcelona, Spain; Etikprovningsmyndigheten, Uppsala, Sweden; Health and Care Research Wales, Wales REC 3, Cardiff, United Kingdom; Advarra Institutional Review Board, Columbia, MD, United States; Vanderbilt Human Research Protection Program (VHRPP) Institutional Review Board, Nashville, TN, United States; University of Utah Institutional Review Board, Salt Lake City, UT, United States; Biomedical Research Alliance of New York, LLC/Institutional Review Board, Lake Success, NY, United States; Western Institutional Review Board, Puyallup, WA, United States; Sharp HealthCare Institutional Review Board, San Diego, CA, United States; Schulman Associates Institutional Review Board, Cincinnati, OH, United States; Loma Linda University Health - Institutional Review Board, Loma Linda, CA, United States; Administrative Panels on Human Subjects in Medical Research (‘Stanford Institutional Review Board’), Palo Alto, CA, United States; University of Maryland, Baltimore - Institutional Review Board, Baltimore, MD, United States; Cook County Health Office of Research and Regulatory Affairs, Chicago, IL, United States; Samaritan Health Services Regional Institutional Review Board, Corvallis, OR, United States; University of Iowa Institutional Review Board-01, Human Subjects Office, Iowa City, IA, United States; Lakeland Regional Medical Center, Inc. Institutional Review Board, Lakeland, FL, United States; VA Med Ctr, Long Beach CA Institutional Review Board #1, Long Beach, CA, United States; Rush University Medical Center Institutional Review Board, Chicago, IL, United States; UCLA Office of the Human Research Protection Program, Los Angeles, CA, United States; VA Saint Louis Healthcare System Institutional Review Board, St. Louis, MO, United States; Baylor Scott and White Research Institute Institutional Review Board-Gold, Temple, TX, United States; Providence St. Joseph Health Institutional Review Board, Renton, WA, United States; IntegReview, Austin, TX, United States; Kaiser Permanente Northwest Institutional Review Board, Portland, OR, United States; Ochsner Institutional Review Board, New Orleans, LA, United States; Eisenhower Medical Center, Institutional Review Board, Rancho Mirage, CA, United States. All patients provided written informed consent.