Active Not Recruiting
PHASE3
INTERVENTIONAL
NCT03767244
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Apalutamide
Type:
DRUG
Description:
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
Name:
Androgen Deprivation Therapy (ADT)
Type:
DRUG
Description:
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 \[ng/dL\]).
Name:
Placebo
Type:
DRUG
Description:
Participants will receive matching placebo oral tablets daily.
Primary Outcomes
Measure:
Percentage of Participants with Pathologic complete response (pCR)
TimeFrame:
Approximately 4 years
Description:
pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.
Measure:
Metastasis-Free Survival (MFS)
TimeFrame:
Up to 7 years and 5 months
Description:
MFS is defined as the time from randomization to the date of the occurrence of radiographic distant metastasis evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
Trial Information
NCT ID
NCT03767244
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Janssen Research & Development, LLC
Last Updated
December 15, 2025