A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer.
Your participation in this trial could last up to 40 months, depending on how you and your tumor respond.
Key Participation Requirements
All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria
• Participant must have diagnosis of prostate cancer that is metastatic • Participant must have prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant) • Participant must have documented evidence of progressive disease by imaging and/or PSA test • Participant must be willing to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research • Participant must not have received any of the following prior therapies: abiraterone acetate, abemaciclib, chemotherapy in the castration-resistant setting, radiopharmaceuticals, enzalutamide, apalutamide, or sipuleucel-T • Participants must not have conditions that are not compatible with the clinical trial participation such as inability to swallow large pills, active or chronic liver disease, clinically significant heart disease, HIV, AIDS, active or uncontrolled clinically serious infection, or uncontrolled hypertension • Participant must not have brain metastases • Participant of reproductive potential must not father a child and must agree to use medically approved contraceptive precautions, and not donate sperm, during the study and for three months following the last dose of study drug