Prostate Cancer Clinical Trial
Official title:
A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy
This study investigates the pathologic effects of the combination of enzalutamide,
abiraterone acetate, dutasteride, and degarelix when given for 12 weeks prior to
prostatectomy in men with localized prostate cancer.
Enzalutamide, an androgen receptor (AR) antagonist, blocks binding of testosterone to the AR
as well as preventing nuclear translocation of the AR and DNA binding. Abiraterone acetate
inhibits the CYP17 pathway, which is involved in the formation of androgens. Dutasteride is
a 5-alpha-reductase inhibitor which blocks conversion of testosterone to
dihydrotestosterone. Degarelix, a gonadotropin-releasing hormone (GnRH) antagonist, binds to
GnRH receptors on the pituitary gland thus suppressing testosterone release from the testes.
Therefore it is hypothesized that the combination of enzalutamide, abiraterone acetate,
dutasteride, and degarelix will result in near-complete AR inhibition and produce favorable
pathologic changes after 12 weeks of therapy.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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