Study Summary
This trial is testing whether abemaciclib, when added to abiraterone plus prednisone, can help to treat prostate cancer by prolonging the time before the cancer gets worse.
- Prostate Cancer
- Abiraterone Acetate
- Enzyme Inhibitors
- Prednisolone
- Androgens
- Hormone Therapy
- Cyclin-Dependent Kinase 6
- Urogenital Neoplasms
- Steroid Synthesis Inhibitors
- Cyclin-Dependent Kinase 4 (CDK4)
- Drug Effects
- Chemotherapy
- Metastatic Cancer
- Hormonal Antineoplastic Agents
- Hormones
- Cytochrome P450
- Prednisone
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Randomization to the earliest date of PSA or radiographic progression with a testosterone level of ≤50 nanogram/deciliter (ng/dL); or death from any cause (approximately 48 months)
Trial Safety
Safety Progress
Side Effects for
Trial Design
2 Treatment Groups
Placebo + Abiraterone + Prednisone/Prednisolone
1 of 2
Abemaciclib + Abiraterone + Prednisone/Prednisolone
1 of 2
Active Control
Experimental Treatment
900 Total Participants · 2 Treatment Groups
Primary Treatment: Abemaciclib · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Male Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
Virginia | 100.0% |
How old are they?
65+ | 100.0% |
What site did they apply to?
Chesapeake Urology | 100.0% |
What portion of applicants met pre-screening criteria?
Did not meet criteria | 100.0% |
Frequently Asked Questions
What is the standing of Abemaciclib with the FDA?
"Abemaciclib's safety is estimated to be a 3. Phase 3 trials have some data supporting efficacy and multiple rounds of data supporting safety." - Anonymous Online Contributor
Where can potential participants find this clinical trial?
"There are 78 locations associated with this trial, but a few notable locations are Texas Oncology - Carrollton in Carrollton, Texas, Genesis Cancer Center in Hot Springs, Arkansas, and Providence Medical Foundation in Fullerton, California." - Anonymous Online Contributor
Are we still receiving participants for this experiment?
"The clinical trial is recruiting patients at this time, as reflected on clinicaltrials.gov. This specific trial was first posted on April 14th, 2022 and received its most recent update on October 19th, 2022." - Anonymous Online Contributor
How many participants are being enrolled in this experiment?
"In order to begin this study, 900 individuals that fit the pre-determined criteria must enroll. These participants can be located at various medical facilities, such as Texas Oncology - Carrollton or Genesis Cancer Center." - Anonymous Online Contributor