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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03767244

Public ClinicalTrials.gov record NCT03767244. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 2:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03767244
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
2,517 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 11, 2019 (Actual)
Primary completion
Dec 1, 2026 (Estimated)
Completion
Oct 13, 2028 (Estimated)
Last update posted
Sep 25, 2026

2019 – 2028

United States locations

U.S. sites
44
U.S. states
22
U.S. cities
39
Facility City State ZIP Site status
UC San Diego Moores Cancer Center La Jolla California 92093 —
University of Southern California Los Angeles California 90033 —
Cedars Sinai Medical Center Los Angeles California 90048 —
University of California Los Angeles Los Angeles California 90095 —
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center Orange California 92868 —
UC Davis Medical Center Sacramento California 95817 —
AdventHealth Medical Group Urology of Denver Denver Colorado 80210 —
Colorado Clinical Research Lakewood Colorado 80228 —
Stamford Hospital Stamford Connecticut 06904 —
Urology Specialists LLC Hialeah Florida 33002 —
Mayo Clinic - Division Of Hematology/oncology Jacksonville Florida 32224 —
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group Miami Florida 33176 —
Advent Health Orlando Florida 32804 —
Emory University Winship Cancer Institute Atlanta Georgia 30322-1013 —
University of Chicago Chicago Illinois 60637 —
Ochsner LSU Health Shreveport - Regional Urology Shreveport Louisiana 71106 —
Dana Farber Cancer Institute Boston Massachusetts 02115 —
Beth Isreal Deaconess Medical Center Boston Massachusetts 02215 —
Michigan Institute of Urology, PC Troy Michigan 48084 —
Saint Louis University St Louis Missouri 63110 —
Urology Cancer Center, PC Omaha Nebraska 68130 —
Albany Medical College Albany New York 12208 —
Great Lakes Physician PC d/b/a Western New York Urology Associates Cheektowaga New York 14225 —
Memorial Sloan-Kettering Cancer Center New York New York 10065 —
Weill Cornell Medical College New York New York 10065 —
SUNY Upstate Medical University Syracuse New York 13210 —
University of North Carolina Chapel Hill North Carolina 27599 —
Duke University School of Medicine Durham North Carolina 27705 —
Medication Management LLC Greensboro North Carolina 27403 —
Carolina Urology Partners, PLLC Huntersville North Carolina 28078 —
Cleveland VA Medical Center Cleveland Ohio 44106 —
Oklahoma City VAMC Oklahoma City Oklahoma 73104 —
MidLantic Urology Bala-Cynwyd Pennsylvania 19004 —
Omega Medical Research Warwick Rhode Island 02886 —
Ralph H. Johnson Veterans Affairs Medical Center Charleston South Carolina 29401 —
Medical University of South Carolina Charleston South Carolina 29403 —
Greenville Health Greenville South Carolina 29605 —
Carolina Urologic Research Center Myrtle Beach South Carolina 29572 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
VA North Texas Health Care System Dallas Texas 75216 —
MD Anderson Cancer Center Houston Texas 77030 —
Virginia Urology Richmond Virginia 23235 —
Urology of Virginia, PLCC Virginia Beach Virginia 23462 —
CAMC Memorial Hospital, Charleston Area Medical Center Physicians Charleston West Virginia 25304 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 159 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03767244, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 25, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03767244 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →