Trial Number

246-22

Condition

Prostate Cancer

Participant Age Range

18 years and older

Participant Gender

Male

Enrolling Participants

Yes

Overview

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 is a multinational, randomized, double-blind, placebo-controlled, Phase 3 study to assess the safety and efficacy of adding abemaciclib to abiraterone plus prednisone in patients with high-risk mHSPC. High-risk is defined as the presence of ≥4 bone metastases and/or ≥1 visceral metastases. Participants will be randomized in a 1:1 ratio to receive abiraterone plus prednisone and abemaciclib (experimental arm) or matching placebo (control arm).

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