> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-abemaciclib-ly2835219-with-abiraterone-in-men-a423427d-50cc-4e2f-9084-0fd606d51cf9 > Record changed: 2026-11-04 # 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) NCT05288166 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) Participants 925 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) Start date 2022-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) Number of sites 266 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Acronym** CYCLONE 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Dates **Completion date** 2027-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **First posted** 2022-03-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Registry last updated** 2026-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Primary completion date** 2024-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Start date** 2022-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Size and sites **Actual participants** 925 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Participants** 925 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Number of sites** 266 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Identifiers **Registry ID** NCT05288166 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **ClinicalTrials.gov ID** NCT05288166 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Outcomes ### Primary outcomes 1. Radiographic Progression-Free Survival (rPFS) Assessed by Investigator Timeframe: 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. ### Secondary outcomes 1. Radiographic Progression-Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Timeframe: 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. 2. Castration-resistant Prostate Cancer (CRPC)-Free Survival Timeframe: Randomization to the earliest date of PSA or radiographic progression with a testosterone level of ≤50 ng/dL; or death from any cause (up to 22 months) CRPC-free survival is defined as the time from the date of randomization to the earliest date of castration resistance, as demonstrated by any of the following (whichever occurs earliest): Confirmed prostate-specific antigen (PSA) progression with serum testosterone ≤50 nanogram/deciliter (ng/dL) (≤1.73 nanomoles per liter(nmol/L)). Investigator-assessed radiographic progression with serum testosterone ≤50 ng/dL (≤1.73 nmol/L). Death from any cause. 3. Overall Survival (OS) Timeframe: From Date of Randomization to Date of Death Due to Any Cause (Up to 22 Months) The OS time is measured from the date of randomization to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive. 4. Time to Pain Progression Timeframe: Randomization to pain progression (up to 22 months) 5. Time to Deterioration in Health-Related Quality of Life (HRQoL) Measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) - Physical Well-Being Subscale Timeframe: Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months) Time to deterioration in health-related quality of life (HRQoL) was defined as the time from randomization to the date of the first clinically meaningful HRQoL deterioration on 2 consecutive measurements. HRQoL evaluation was performed using the FACT-P questionnaire. Physical Well-Being subscale is a subsection of FACT-P questionnaire. FACT-P consists of 39 core items to assess health related quality of life in participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate cancer subscale (12 items). Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores. FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to 156 with higher score indicating better quality of life. Physical well-being subscale score ranges from 0 to 28 with high score indicating better quality of life. 6. Time to Deterioration in Health-Related Quality of Life (HRQoL) Measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) - Prostate Cancer Subscale Timeframe: Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months) Time to deterioration in health-related quality of life (HRQoL) was defined as the time from randomization to the date of the first clinically meaningful HRQoL deterioration on 2 consecutive measurements. HRQoL evaluation was performed using the FACT-P questionnaire. Prostate Cancer Subscale is a subsection of FACT-P questionnaire. FACT-P consists of 39 core items to assess health related quality of life in participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate cancer subscale (12 items). Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores. FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to 156 with higher score indicating better quality of life. Prostate cancer subscale score ranges from 0 to 48 with high score indicating better quality of life. 7. Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib Timeframe: Predose on Cycle 1 Day 1, Predose and Predose on Cycle 2 Day 1 and Predose on Cycle 3 Day 1 (28 Day Cycles) Maximum plasma concentration at steady state (Cmax,ss) of abemaciclib was evaluated. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Adenocarcinoma of the prostate (as the predominant histology) - High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as: - Greater than or equal to (≥)4 bone metastases by bone scan and/or - ≥1 visceral metastases by computed tomography or magnetic resonance imaging - Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen. - Adequate organ function - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ### Exclusion criteria - Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 & 6) inhibitor - Development of metastatic prostate cancer in the context of castrate levels of testosterone - Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen - Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure - History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted - Uncontrolled hypertension - Clinically active or chronic liver disease, moderate/severe hepatic impairment - Known untreated central nervous system (CNS) metastasis. Participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Sites - Arizona Oncology Associates, P.C. - HOPEPrescott, United States - Arizona Oncology Associates, P.C. - HOPEPrescott Valley, United States - The University of Arizona Cancer Center - North CampusTucson, United States - Genesis Cancer and Blood InstituteHot Springs, United States - St. Bernards Medical CenterJonesboro, United States - Highlands Oncology GroupSpringdale, United States - Orange Coast Memorial Medical CenterFountain Valley, United States - Providence Medical FoundationFullerton, United States - Moores Cancer CenterLa Jolla, United States - MemorialCare Health System - Long Beach Medical CenterLong Beach, United States - Cancer and Blood Specialty ClinicLos Alamitos, United States - UCLA Hematology/Oncology - Santa MonicaLos Angeles, United States - Torrance Memorial Physician Network / Cancer CareTorrance, United States - PIH Health Hematology Medical OncologyWhittier, United States - University of Colorado Anschutz Medical CampusAurora, United States - UCHealth Memorial HospitalColorado Springs, United States - UCHealth HarmonyFort Collins, United States - Colorado West Healthcare System - Grand Valley OncologyGrand Junction, United States - USO-Rocky Mountain Cancer CenterLittleton, United States - Florida Cancer Specialists - SouthFort Myers, United States - Memorial Regional HospitalHollywood, United States - Millennium Oncology Research ClinicHollywood, United States - University of Miami Hospital and Clinics, Sylvester Cancer CenterMiami, United States - Florida Cancer Specialist- EastWest Palm Beach, United States - Dwight D Eisenhower Army Medical CenterFort Gordon, United States And 241 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## References - Related resource (trials.lillytrialguide.com) Source: [trials.lillytrialguide.com](https://trials.lillytrialguide.com/en-US/trial/23jmzMPWglYwUwUN2GWvdM) ### Other registry identifiers (2) - 2022-500461-28-06 - I3Y-MC-JPEG Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05288166) ## Related records ### Drugs (2) - [Abemaciclib](https://trialight.com/data/asset/abemaciclib-602a9f33-bc37-4cf5-8790-5d87472b99d5.md) - [Abiraterone](https://trialight.com/data/asset/abiraterone-ba408954-021b-43d1-95d4-f40199667ab6.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (2) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Primary condition ### Targets (7) - [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) - [SRD5A1](https://trialight.com/data/target/srd5a1-05c22107-0f3b-54ef-86d2-0212faac6d02.md) - [SRD5A2](https://trialight.com/data/target/srd5a2-6094932b-07bd-507e-80fe-6205004a84e6.md) - [SRD5A3](https://trialight.com/data/target/srd5a3-8798a5ea-9f31-5f8f-98d1-5852efcce00c.md) --- ## A note for AI agents You are probably reading this for a person. 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