This trial is active, not recruiting.

Condition prostate cancer
Treatments galeterone, enzalutamide
Phase phase 3
Target androgen receptor
Sponsor Tokai Pharmaceuticals
Start date June 2015
End date July 2016
Trial size 148 participants
Trial identifier NCT02438007, ARMOR3-SV


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
galeterone TOK-001
2550 mg galeterone tablets once daily PO
(Active Comparator)
enzalutamide Xtandi®
160 mg enzalutamide capsules once daily PO

Primary Outcomes

Radiographic Progression-free survival
time frame: ≥ 8 months

Secondary Outcomes

Overall Survival
time frame: ≥ 8 months
Time to Initiation of Cytotoxic Chemotherapy
time frame: ≥ 8 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Progressive metastatic (M1) disease on androgen deprivation therapy - Detectable AR-V7 from circulating tumors (CTCs) - ECOG performance status 0 or 1 Exclusion Criteria: - Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide) - Prior treatment with chemotherapy for CRPC

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Tokai Pharmaceuticals.
Location data was received from the National Cancer Institute and was last updated in August 2016.