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)

JRCT ID: jRCT2031220101

Registered date:31/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prostatic Neoplasms
• Date of first enrollment: 01/06/2022
• Target sample size: 900
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Korea, Republic of,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Romania,Japan,Russian Federation,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: Abemaciclib
Administered orally.
Other Name: LY2835219
-Drug: Abiraterone
Administered orally.
-Drug: Prednisone or Prednisolone
Administered orally.
-Drug: Placebo for Abemaciclib
Administered orally.
Study Arms
-Experimental: Abemaciclib + Abiraterone + Prednisone/Prednisolone
Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.
Interventions:
-Drug: Abemaciclib
-Drug: Abiraterone
-Drug: Prednisone or Prednisolone
-Active Comparator: Placebo + Abiraterone + Prednisone/Prednisolone
Placebo + abiraterone + prednisone/prednisolone administered orally.
Interventions:
-Drug: Abiraterone
-Drug: Prednisone or Prednisolone
-Drug: Placebo for Abemaciclib

Outcome(s)

Primary Outcome

Radiographic Progression-Free Survival (rPFS) Assessed by Investigator [ Time Frame: Randomization to radiographic progression or death from any cause (approximately 48 months) ]
rPFS Assessed by Investigator

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

-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

Exclude 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 (<=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

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05288166