Completed Enrollment

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3)

The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Prostate Cancer
What the trial is testing?
Abemaciclib, Abiraterone, LY2835219, Prednisone, Prednisolone
Could I receive a Placebo?
No
Enrollment Goal
900
Trial Dates
Apr 14, 2022 - Oct 2027
How long will I be in the trial?
Your participation in this trial could last up to 60 months, depending on how you and your tumor respond.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must have prostate cancer that has spread to other parts of the body and is expected to respond to hormone treatments designed to lower testosterone (metastatic hormone-sensitive prostate cancer)

  • Participant must have cancer that has spread to the bones significantly 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)

  • Participant must have adequate organ function

Participants Must Not:

  • Participant must not have received prior treatment with abemaciclib or other drugs that work in the same way

  • Participant must not have received previous treatment(s) for metastatic cancer except for up to 3 months of androgen deprivation therapy (ADT) or up to 6 courses of chemotherapy with ADT

  • Participant must not have serious or uncontrolled medical conditions such as certain cardiovascular disorders, active or chronic liver disease, uncontrolled hypertension, active systemic infections or currently treated for cancer other than prostate

  • Participant must not have prostate cancer that has spread to the central nervous system that is not treated and stable

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Clinical Trial Resources

Prostate Cancer Research

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Prostate Cancer Research

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Clinical Trial Participation: What to Expect

A clinical trial is a scientific study. It helps us learn if a new medicine or treatment works and how it works. Clinical trials can also be called clinical research studies. Learn more about clinical research studies and what to expect when taking part in a clinical trial.