common.study.topics.clinical

Locally Advanced Prostate Cancer Treatment

common.study.values.description

A Study of Apalutamide in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy 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.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Recruiting patients only common.study.methods.is-healthy-yes

Drug - Apalutamide

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

Drug - Androgen Deprivation Therapy (ADT)

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]).

Drug - Placebo

Participants will receive matching placebo oral tablets daily.

participant.views.study.view.additional

participant.views.study.view.scientific-title

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

common.study.values.clinical-trial-id

NCT03767244

participant.views.study.view.id

eVO05a