Protocol No
AFT-19-PRESTO
Principal Investigator
Deepak Kilari
Phase
III
Summary
Degarelix is an injection that is approved by the U.S. Food and Drug Administration (FDA) to
treat advanced prostate cancer. It is in a class of drugs called gonadotropin-releasing hormone
(GnRh) receptor antagonists. It works by decreasing the amount of testosterone (a male
hormone) produced by the body.
Abiraterone acetate is another type of hormone therapy that is FDA-approved for advanced
prostate cancer. Abiraterone acetate works by blocking an enzyme (protein) called cytochrome
P17. Abiraterone acetate is a form of androgen deprivation therapy (ADT), or hormone therapy.
The goal of ADT is to reduce levels of male hormones, called androgens, in the body, in order to
stop them from affecting prostate cancer cells. Prednisone (a corticosteroid) is given with
abiraterone acetate to stop or reduce its associated side effects.
Though Degarelix and Abiraterone acetate are FDA-approved for use in prostate cancer as
single drugs, the combination is still being studied. This means that the combination of the two
drugs is investigational and is not FDA-approved in the United States for men with high-risk
prostate cancer after surgery.
Although ADT is initially effective in lowering PSA, men with advanced prostate cancer often
relapse. This study is being done to see if adding an experimental drug called apalutamide, or
adding both apalutamide and abiraterone acetate as an experimental drug combination, to
Degarelix alone will prevent prostate cancer from relapsing.
Description
A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
ClinicalTrials.gov