CYCLONE 3: Abemaciclib with Abiraterone in Men with High-Risk mHSPC
Research type
Research Study
Full title
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
IRAS ID
1005465
Contact name
Katarzyna Pluzanska
Contact email
Sponsor organisation
Eli Lilly and Company
Clinicaltrials.gov Identifier
Research summary
Prostate cancer is a leading cause of mortality and morbidity worldwide. Abemaciclib is an oral drug
that blocks the activity of proteins called CDK4 and CDK6, and helps stop the growth of cancer cells.
The aim of this research is to determine the safety and efficacy of abemaciclib when it is given with
abiraterone plus prednisolone as a treatment for men with high-risk metastatic hormone-sensitive
prostate cancer (mHSPC). High-risk means that prostate cancer has spread to the bones with ≥ 4
lesions and/or to the viscera, which are the soft internal organs of the body (for example, the lungs,
liver, and the organs of the digestive system). Participants will have a 50% chance of receiving
abemaciclib or a placebo (a substance that looks like abemaciclib but has no active ingredients). All
participants will receive abiraterone plus prednisolone. Approximately 900 men (including 29 from
the UK) will take part in the research.REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0520
Date of REC Opinion
24 Oct 2022
REC opinion
Further Information Favourable Opinion