CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,052 enrolled / 1,052 target
Drug / intervention
Apalutamide +2 moredrug
Likely dose
Apalutamide 240 mg (4 × 60 mg tablets) orally once dailyAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed prostate adenocarcinoma
  • ✓Metastatic disease with ≥1 bone lesions on bone scan (single lesion requires CT/MRI confirmation)
  • ✓ECOG performance status 0 or 1
  • ✓Prior docetaxel for mHSPC allowed if ≤6 cycles, last dose ≤2 months prior, and stable disease or better response
Key exclusion· 7
  • ✕Histology of small cell, ductal, or neuroendocrine carcinoma of prostate
  • ✕Brain metastases
  • ✕Lymph nodes as only site of metastases
  • ✕Liver or lung metastases as only sites of metastases

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

Search/NCT02489318
NCT02489318Phase 3ActiveUpdate Overdue (8.3/mo)Completion was 69mo ago
CompareCT.gov

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Aragon Pharmaceuticals, Inc.·interventional·Posted Jul 3, 2015·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating Apalutamide, Placebo, and 1 other intervention for Prostate Cancer. Active but no longer recruiting, targeting 1,052 participants across 220 sites in 22 countries.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesArgentina, Australia, Brazil, Canada, China, Czechia, France, Germany, Hungary, Israel, Japan, Mexico, Poland, Romania, Russia, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
2016201720182019202020212022202320242025202620272028
First PostedJul 3, 2015
Enrollment StartNov 27, 2015
Primary CompletionSep 7, 2020
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.0 years ago

Arms & Interventions

Apalutamide plus ADTexperimental

Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.

Drug: ApalutamideDrug: Androgen Deprivation Therapy (ADT)
Placebo plus ADTexperimental

Participants will receive matching Placebo with ADT.

Drug: PlaceboDrug: Androgen Deprivation Therapy (ADT)

Interventions

Apalutamidedrug

Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.

Placebodrug

Participants will receive Placebo orally once daily in each 28 day treatment cycles.

Androgen Deprivation Therapy (ADT)drug

All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.