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Clinical Trial Active — Not Recruiting Phase III NCT03767244

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

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy — Active Not Recruiting • Phase III •…

📅 05 Jun 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT03767244
Start
2019-06-11
Completion
2026-12-01
ClinicaliQ Trial Snapshot
  • A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy — Active Not Recruiting • Phase III • Oncology • NCT03767244.
  • Apalutamide with hormone therapy before and after prostate surgery improves cancer control in high-risk localised prostate cancer.

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What This Trial Is Studying

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. Conditions: Prostatic Neoplasms Interventions: Apalutamide, Androgen Deprivation Therapy (ADT), Placebo Lead Sponsor: Janssen Research & Development, LLC Planned Enrollment: 2517 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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