At a glance

ClinicalIndex Comparison Record

Phase 3Active· 2,517 enrolled / 2,517 target

Drug / intervention

Apalutamide +2 moredrug

Likely dose

Apalutamide 240 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03767244

NCT03767244Phase 3ActiveMonitor (29.7/mo)

Compare CT.gov

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Janssen Research & Development, LLC·interventional·Posted Dec 6, 2018·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating Apalutamide, Androgen Deprivation Therapy (ADT), and 1 other intervention for Prostatic Neoplasms. Active but no longer recruiting, targeting 2,517 participants across 203 sites in 18 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsProstatic Neoplasms

CountriesArgentina, Australia, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom, United States

Collaborators--

Timeline

Phase 3Active

20192020202120222023202420252026202720282029

First PostedDec 2018

Enrollment StartJun 2019

TodayJul 2026

Primary CompletionDec 2026

Study CompletionOct 2028

First PostedDec 6, 2018

Enrollment StartJun 11, 2019

Primary CompletionDec 1, 2026

Study CompletionOct 13, 2028

TodayJul 2, 2026

Enrollment to primary: 7.5 yearsPosted 7.6 years agoPrimary completion in 5 months

Arms & Interventions

Apalutamide + ADTexperimental

Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment. A Long-Term Extension (LTE) may be initiated at sponsor's discretion after completion of the primary endpoint analysis.

Drug: ApalutamideDrug: Androgen Deprivation Therapy (ADT)

Placebo + ADTexperimental

Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment. A LTE may be initiated at sponsor's discretion after completion of the primary endpoint analysis.

Drug: Androgen Deprivation Therapy (ADT)Drug: Placebo

Interventions

Apalutamidedrug

Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.

Androgen Deprivation Therapy (ADT)drug

Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter \[ng/dL\]).

Placebodrug

Participants will receive matching placebo oral tablets daily.