CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer
CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
Inclusion Criteria:
Adenocarcinoma of the prostate (as the predominant histology)
High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:
Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen.
Adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
Grand Junction, Colorado 81505, United States
Miami, Florida 33136, United States
Louisville, Kentucky 40202, United States
Mineola, New York 11501, United States
Ciudad Autónoma de Buenos Aire, Buenos Air C1027AAP, Argentina
CABA, Ciudad Autónoma de Buenos Aire 1125, Argentina
Capital, Córdoba Province X5008HHW, Argentina
Macquarie University, New South Wales 2109, Australia
Brest, Brittany Region 29200, France
Münster, North Rhine-Westphalia 48149, Germany
Budapest, Pest County 1122, Hungary
Ramat Gan, Central District 5265601, Israel
Haifa, Northern District 3109601, Israel
Meldola, Emilia-Romagna 47014, Italy
Kita, Kagawa-ken 761-0701, Japan
Tomitake, Nagano 381-8551, Japan
Shinagawa, Tokyo 142-8555, Japan
Culiacán, Sinaloa 80230, Mexico
Opole, Opole Voivodeship 45-061, Poland
Florești, Cluj 407280, Romania
Seoul, Seoul-teukbyeolsi [Seoul] 03722, South Korea
Hospitalet, Barcelona [Barcelona] 08907, Spain
Taipei City, Taipei 10002, Taiwan
Taipei City, Taipei 11217, Taiwan
Stanbul, Istanbul 34214, Turkey (Türkiye)
Izmir, Karsiyaka, İzmir 009035575, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)