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)
Public ClinicalTrials.gov record NCT05288166. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CYCLONE 3: 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05288166
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 925 participants
Conditions and interventions
Conditions
- Prostatic Neoplasms
- Neoplasm Metastasis
- Urogenital Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Androgens
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Abiraterone Acetate
- Steroid Synthesis Inhibitors
- Cytochrome P-450
- Enzyme Inhibitors
- Prednisone
- Prednisolone
- Cyclin-Dependent Kinase 4
- Cyclin-Dependent Kinase 6
Interventions
- Abemaciclib Drug
- Abiraterone Drug
- Prednisone or Prednisolone Drug
- Placebo for Abemaciclib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 14, 2022 (Actual)
- Primary completion
- Feb 15, 2024 (Actual)
- Completion
- Oct 2027 (Estimated)
- Last update posted
- Jul 1, 2026
2022 – 2027
United States locations
- U.S. sites
- 63
- U.S. states
- 22
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates, P.C. - HOPE | Prescott | Arizona | 86301 | — |
| Arizona Oncology Associates, P.C. - HOPE | Prescott Valley | Arizona | 86314 | — |
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | 85719 | — |
| Genesis Cancer and Blood Institute | Hot Springs | Arkansas | 71913 | — |
| St. Bernards Medical Center | Jonesboro | Arkansas | 72401 | — |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | — |
| Orange Coast Memorial Medical Center | Fountain Valley | California | 92708 | — |
| Providence Medical Foundation | Fullerton | California | 92835 | — |
| Moores Cancer Center | La Jolla | California | 92093 | — |
| MemorialCare Health System - Long Beach Medical Center | Long Beach | California | 90806 | — |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | 90720 | — |
| UCLA Hematology/Oncology - Santa Monica | Los Angeles | California | 90404 | — |
| Torrance Memorial Physician Network / Cancer Care | Torrance | California | 90505 | — |
| PIH Health Hematology Medical Oncology | Whittier | California | 90602 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| UCHealth Memorial Hospital | Colorado Springs | Colorado | 80909 | — |
| UCHealth Harmony | Fort Collins | Colorado | 80528 | — |
| Colorado West Healthcare System - Grand Valley Oncology | Grand Junction | Colorado | 81505 | — |
| USO-Rocky Mountain Cancer Center | Littleton | Colorado | 80120 | — |
| Florida Cancer Specialists - South | Fort Myers | Florida | 33901 | — |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Millennium Oncology Research Clinic | Hollywood | Florida | 33024 | — |
| University of Miami Hospital and Clinics, Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Florida Cancer Specialist- East | West Palm Beach | Florida | 33401 | — |
| Dwight D Eisenhower Army Medical Center | Fort Gordon | Georgia | 30905 | — |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | — |
| Central Georgia Cancer Care | Macon | Georgia | 31201 | — |
| Summit Cancer Care DBA Candler Medical Oncology Practice | Savannah | Georgia | 31405 | — |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46804 | — |
| The University of Louisville, James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| Sarah Cannon Research Institute | Baton Rouge | Louisiana | 70809 | — |
| Chesapeake Urology | Towson | Maryland | 21204 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Reliant Medical Group | Worcester | Massachusetts | 01606 | — |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | — |
| Minnesota Oncology/Hematology PA | Minneapolis | Minnesota | 55404 | — |
| Care Access - Clifton | Clifton | New Jersey | 07013 | — |
| Maimonides Cancer Center | Brooklyn | New York | 11220 | — |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| Laura and Isaac Perlmutter Cancer Center | New York | New York | 10016 | — |
| Associated Medical Professionals - Urology | Syracuse | New York | 13210 | — |
| Clinical Research Alliance | Westbury | New York | 11590 | — |
| TriState Urologic Services PSC Inc. | Cincinnati | Ohio | 45212 | — |
| Northwest Cancer Specialist | Tigard | Oregon | 97223 | — |
| MidLantic urology | Bala-Cynwyd | Pennsylvania | 19004 | — |
| AHN Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Tennessee Oncology Chattanooga-SCRI | Chattanooga | Tennessee | 37404 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Balcones | Austin | Texas | 78731 | — |
| Parkland Health and Hospital System | Dallas | Texas | 75235 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Texas Oncology - Carrollton | Flower Mound | Texas | 75028 | — |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Urology San Antonio Research | San Antonio | Texas | 78229 | — |
| USO - Texas Oncology Gulf Coast | Sugar Land | Texas | 77479 | — |
| Baylor Scott & White Medical Center - Temple | Temple | Texas | 76508 | — |
| US Oncology Research Network | The Woodlands | Texas | 77380 | — |
| Texas Oncology - Longview Cancer Center | Tyler | Texas | 75702 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| The University of Vermont Medical Center Inc. | Burlington | Vermont | 05405 | — |
| Oncology and Hematology Associates of Southwest Virginia Inc | Roanoke | Virginia | 24014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 203 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05288166, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05288166 live on ClinicalTrials.gov.