Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by John Shen (ucla)

Description

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.

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

Keywords

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 Metastatic Hormone Sensitive Prostate Cancer mHSPC Stage IV Prostate Cancer Recurrent Prostate Cancer De Novo Metastatic Prostate Cancer High-Risk Visceral metastasis Cyclin-Dependent Kinase 4 (CDK4) Cyclin-Dependent Kinase 6 (CDK6) CDK4 CDK6 CDK4/6 Neoplasms Hypersensitivity Abemaciclib Abiraterone Prednisone or Prednisolone Abemaciclib + Abiraterone + Prednisone/Prednisolone

Eligibility

You can join if…

Open to males ages 18 years and up

  • Adenocarcinoma of the prostate.
  • High-risk metastatic disease defined as:
  • Greater than or equal to (≥)4 bone metastases and/or
  • ≥1 visceral metastases
  • Androgen deprivation therapy (either medical with a luteinizing hormone-releasing hormone [LHRH] analogue or surgical castration) must have been started prior to randomization and continued throughout the study.
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You CAN'T join if...

  • 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 (≤50 ng/dL)
  • Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), the following exceptions are permitted:
  • Up to 3 months of androgen deprivation therapy (ADT) (when given without docetaxel) AND absence of radiographic or prostate specific antigen (PSA) progression prior to randomization
  • Up to 6 cycles of docetaxel with ADT AND absence of radiographic or PSA progression prior to randomization
  • 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. Patients with a history of treated brain metastases are eligible provided that disease is stable following treatment for at least 8 weeks prior to randomization and no requirement for corticosteroid use

Locations

  • UCLA Hematology/Oncology - Santa Monica not yet accepting patients
    Los Angeles California 90404 United States
  • TRIO-US (Translational Research in Oncology-US) accepting new patients
    Los Angeles California 90024 United States
  • Moores Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • Orange Coast Memorial Medical Center not yet accepting patients
    Fountain Valley California 92708 United States
  • Cancer and Blood Specialty Clinic accepting new patients
    Los Alamitos California 90720 United States
  • Torrance Memorial Physician Network / Cancer Care accepting new patients
    Torrance California 90505 United States
  • Providence Medical Foundation accepting new patients
    Fullerton California 92835 United States
  • MemorialCare Health System - Long Beach Medical Center not yet accepting patients
    Long Beach California 90806 United States
  • PIH Health Hematology Medical Oncology accepting new patients
    Whittier California 90602 United States

Lead Scientist at University of California Health

  • John Shen (ucla)
    HS Assistant Clinical Professor, Medicine

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT05288166
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 900 study participants
Last Updated