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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Abemaciclib: Administered orally.
Abiraterone: Administered orally.
Prednisone or Prednisolone: Administered orally.
Placebo for Abemaciclib: Administered orally.
Study summary
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
Eligibility
Primary outcome measure(s)
- Radiographic Progression-Free Survival (rPFS) Assessed by Investigator — From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)
The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.
Trial sites (266)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Oncology Associates, P.C. - HOPE | Prescott | Arizona | |
| Arizona Oncology Associates, P.C. - HOPE | Prescott Valley | Arizona | |
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | |
| Genesis Cancer and Blood Institute | Hot Springs | Arkansas | |
| St. Bernards Medical Center | Jonesboro | Arkansas | |
| Highlands Oncology Group | Springdale | Arkansas | |
| Orange Coast Memorial Medical Center | Fountain Valley | California | |
| Providence Medical Foundation | Fullerton | California | |
| Moores Cancer Center | La Jolla | California | |
| MemorialCare Health System - Long Beach Medical Center | Long Beach | California | |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | |
| UCLA Hematology/Oncology - Santa Monica | Los Angeles | California | |
| Torrance Memorial Physician Network / Cancer Care | Torrance | California | |
| PIH Health Hematology Medical Oncology | Whittier | California | |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | |
| UCHealth Memorial Hospital | Colorado Springs | Colorado | |
| UCHealth Harmony | Fort Collins | Colorado | |
| Colorado West Healthcare System - Grand Valley Oncology | Grand Junction | Colorado | |
| USO-Rocky Mountain Cancer Center | Littleton | Colorado | |
| Florida Cancer Specialists - South | Fort Myers | Florida | |
| Memorial Regional Hospital | Hollywood | Florida | |
| Millennium Oncology Research Clinic | Hollywood | Florida | |
| University of Miami Hospital and Clinics, Sylvester Cancer Center | Miami | Florida | |
| Florida Cancer Specialist- East | West Palm Beach | Florida | |
| Dwight D Eisenhower Army Medical Center | Fort Gordon | Georgia | |
| Northeast Georgia Medical Center | Gainesville | Georgia | |
| Central Georgia Cancer Care | Macon | Georgia | |
| Summit Cancer Care DBA Candler Medical Oncology Practice | Savannah | Georgia | |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | |
| The University of Louisville, James Graham Brown Cancer Center | Louisville | Kentucky | |
| Sarah Cannon Research Institute | Baton Rouge | Louisiana | |
| Chesapeake Urology | Towson | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Reliant Medical Group | Worcester | Massachusetts | |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | |
| Minnesota Oncology/Hematology PA | Minneapolis | Minnesota | |
| Care Access - Clifton | Clifton | New Jersey | |
| Maimonides Cancer Center | Brooklyn | New York | |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island | Mineola | New York | |
| Laura and Isaac Perlmutter Cancer Center | New York | New York |
+ 226 more sites — see the full list on the official registry below.
More Eli Lilly and Company trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05288166 on ClinicalTrials.gov ↗ ← All trials in Spain