ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)
Description
Brief Summary
The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen
receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer
(CRPC).
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion Criteria
- Progressive metastatic (M1) disease on androgen deprivation therapy
- Detectable AR-V7 from circulating tumors (CTCs)
- ECOG performance status 0 or 1
- Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
- Prior treatment with chemotherapy for CRPC
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.