NCT05288166 (CYCLONE 3) is a Phase 3 clinical trial of Abemaciclib in Prostatic Neoplasms, sponsored by Eli Lilly and Company.

Who is sponsoring NCT05288166?

NCT05288166 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT05288166?

Interventions in NCT05288166: Abemaciclib, Abiraterone, Prednisone or Prednisolone, Placebo for Abemaciclib.

What condition does NCT05288166 study?

NCT05288166 studies 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.

Is NCT05288166 still recruiting?

NCT05288166 is currently active, enrolled. Last updated 10 June 2025.

Are results published for NCT05288166?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-06-10 · How we verify

NCT05288166: CYCLONE 3

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Results posted Last updated 10 June 2025

What this trial tests

Phase 3 trial testing Abemaciclib in Prostatic Neoplasms in 925 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 April 2022

Primary endpoint
15 February 2024

1 October 2027

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	925
Start date	14 April 2022
Primary completion	15 February 2024
Estimated completion	1 October 2027
Sites	266 locations across United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia

Drugs / interventions tested

Abemaciclib (abemaciclib) — full drug profile →
Abiraterone (ABIRATERONE) — full drug profile →
Prednisone or Prednisolone
Placebo for Abemaciclib — full drug profile →

Conditions studied

Prostatic Neoplasms — all drugs for Prostatic Neoplasms →
Neoplasm Metastasis — all drugs for Neoplasm Metastasis →
Urogenital Neoplasms — all drugs for Urogenital Neoplasms →
Physiological Effects of Drugs — all drugs for Physiological Effects of Drugs →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, male only, with Prostatic Neoplasms or Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Radiographic Progression-Free Survival (rPFS) Assessed by Investigator
Time frame: 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 o

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

De Novo Metastatic Prostate Cancer: Are We Moving toward a Personalized Treatment?
Piombino C, Oltrecolli M, Tonni E, Pirola M, et al · · 2023 · cited 17× · PMID 37894312 · DOI 10.3390/cancers15204945
Androgen Receptor Signaling Inhibition in Advanced Castration Resistance Prostate Cancer: What Is Expected for the Near Future?
Pozas J, Álvarez Rodríguez S, Fernández VA, Burgos J, et al · · 2022 · cited 16× · PMID 36551557 · DOI 10.3390/cancers14246071
A Signal-Finding Study of Abemaciclib in Heavily Pretreated Patients with Metastatic Castration-Resistant Prostate Cancer: Results from CYCLONE 1.
Agarwal N, Castellano D, Alonso-Gordoa T, Arranz Arija JA, et al · · 2024 · cited 12× · PMID 38512117 · DOI 10.1158/1078-0432.ccr-23-3436
Triplet Therapy in Metastatic Castrate Sensitive Prostate Cancer (mCSPC)-A Potential New Standard of Care.
Mittal A, Sridhar SS, Ong M, Jiang DM. · · 2023 · cited 11× · PMID 37185445 · DOI 10.3390/curroncol30040332
Cyclin-Dependent Kinase Inhibition in Prostate Cancer: Past, Present, and Future.
Siskin M, Economides MP, Wise DR. · · 2025 · cited 7× · PMID 40075623 · DOI 10.3390/cancers17050774
Metastatic hormone-naïve prostate cancer: a distinct biological entity.
Corres-Mendizabal J, Zacchi F, Martín-Martín N, Mateo J, et al · · 2024 · cited 7× · PMID 39048488 · DOI 10.1016/j.trecan.2024.06.005
Future directions in systemic treatment of metastatic hormone-sensitive prostate cancer.
Chen K, Kostos L, Azad AA. · · 2023 · cited 7× · PMID 36029329 · DOI 10.1007/s00345-022-04135-8
Role of N<sup>6</sup>‑methyladenosine in the pathogenesis, diagnosis and treatment of prostate cancer (Review).
Pan J, Tong F, Ren N, Ren L, et al · · 2024 · cited 5× · PMID 38757383 · DOI 10.3892/or.2024.8747

Verify or expand the search:

Other trials of Abemaciclib

Trials testing the same drug.

NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco · Phase 2 · not yet recruiting
NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis · Phase 1, PHASE2 · recruiting
NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer · Phase 2 · enrolling by invitation

Other recruiting trials for Prostatic Neoplasms

Currently open trials in the same condition.

NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
NCT07319871 — A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer · Phase 1 · recruiting
NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
NCT07451002 — A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France · recruiting
NCT06547398 — Prostate Adaptive Radiation Therapy · NA · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05288166 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 10 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05288166.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing