Abemaciclib + Hormone Therapy for Prostate Cancer
(RAD 1805 Trial)
Trial Summary
What is the purpose of this trial?
This Phase II study is designed to study the clinical and radiologic response, as well as, safety and tolerability of abemaciclib in combination with androgen deprivation therapy (ADT) in patients with localized high-risk or locally advanced prostate cancer who are eligible for definitive radiation therapy (RT) and androgen deprivation therapy (ADT).
Research Team
Andrew McDonald, MD
Principal Investigator
University of Alabama at Birmingham (UAB)
Eligibility Criteria
Men with high-risk or advanced prostate cancer that hasn't spread, who haven't had systemic anti-cancer treatments. They must have a certain level of health, including normal organ function and blood counts, be able to perform daily activities with ease or some difficulty (ECOG PS=0 or 1), and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abemaciclib in combination with androgen deprivation therapy (ADT) and radiation therapy (RT). ADT starts 3 months before RT, and abemaciclib is paused 2 weeks prior to RT and resumes 1 month post-RT.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abemaciclib
- Androgen deprivation therapy (ADT)
Abemaciclib is already approved in United States, European Union for the following indications:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University