Clinical trial · Interventional
A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
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)
NCT02438007CI-TRIAL-00064711ARMOR3-SVterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Galeterone | Drug | Galeterone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Galeterone
- interventionNames
- Drug: Galeterone
- type
- ACTIVE_COMPARATOR
- label
- Enzalutamide
- interventionNames
- Drug: Enzalutamide
Primary outcomes (1)
- measure
- Radiographic Progression-free survival
- timeFrame
- ≥ 8 months
Secondary outcomes (2)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAragon-Ching JB. The promising role of poly(ADP-ribose) polymerase inhibitors in prostate cancer. Asian J Androl. 2016 Jul-Aug;18(4):592-3. doi: 10.4103/1008-682X.172821. PMID 26908063