- 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.
Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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