CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,207 enrolled / 1,207 target
Drug / intervention
Apalutamide +1 moredrug
Likely dose
Apalutamide 240 mg orally once dailyAI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • ✓High risk for metastases defined as PSA doubling time ≤10 months (calculated using at least 3 PSA values during continuous ADT)
  • ✓Castration-resistant prostate cancer: 3 PSA rises at least 1 week apart, with last PSA >2 ng/mL, all during continuous ADT
  • ✓Maintain castrate levels of testosterone within 4 weeks prior to randomization and throughout the study
Key exclusion· 9
  • ✕Presence of confirmed distant metastases, including CNS and vertebral or meningeal involvement
  • ✕Symptomatic local or regional disease requiring medical intervention
  • ✕Prior treatment with second generation anti-androgens
  • ✕Prior treatment with CYP17 inhibitors

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01946204
NCT01946204Phase 3ActiveUpdate Overdue (7.9/mo)Completion was 109mo ago
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

Aragon Pharmaceuticals, Inc.·interventional·Posted Sep 19, 2013·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating Apalutamide and Placebo for Prostatic Neoplasms. Active but no longer recruiting, targeting 1,207 participants across 379 sites in 25 countries.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Japan, Netherlands, New Zealand, Norway, Poland, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
201420152016201720182019202020212022202320242025202620272028
First PostedSep 19, 2013
Enrollment StartOct 14, 2013
Primary CompletionMay 19, 2017
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.8 years ago

Arms & Interventions

Treatment Arm A: Apalutamideexperimental

Drug: Apalutamide
Treatment Arm B: Placeboplacebo_comparator

Drug: Placebo

Interventions

Apalutamidedrug

240 mg tablets administered by mouth on a continuous once daily dosing regimen

Placebodrug

Matched placebo tablets administered by mouth on a continuous once daily dosing regimen