CER San Juan | San Juan, Argentina
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Adenocarcinoma of the prostate (as the predominant histology)
High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:
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
Primary purpose
Allocation
Interventional model
Masking
900 participants in 2 patient groups
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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