A Phase 3, randomised, double-blind, placebo-controlled study of abemaciclib with abiraterone plus prednisone in patients with high-risk mHSPC - I3Y-MC-JPEG (CYCLONE 3)

Studio Clinico

Patologia: Carcinoma della prostata

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

Abemaciclib (Verzenios)

Trattamento di controllo: 

Abiraterone/Prednisone

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-005370-25

Data di inserimento: 08.11.2022

Data di aggiornamento: 07.04.2023

Promotore

Eli Lilly

Principal Investigator ITALIA

Ospedale Santa Chiara, Trento

Riferimento: Dr. Orazio Caffo

Telefono: 0461902121

Email: orazio.caffo@apss.tn.it

Localita: Trento