๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-27

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy (NCT03767244)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UC San Diego Moores Cancer Center โ€” La Jolla, California

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (203 Sites)

Showing the first 25 of 203 sites.

  • UC San Diego Moores Cancer Center โ€” La Jolla, California
  • University of Southern California โ€” Los Angeles, California
  • Cedars Sinai Medical Center โ€” Los Angeles, California
  • University of California Los Angeles โ€” Los Angeles, California
  • University of California Irvine Medical Center Chao Family Comprehensive Cancer Center โ€” Orange, California
  • UC Davis Medical Center โ€” Sacramento, California
  • AdventHealth Medical Group Urology of Denver โ€” Denver, Colorado
  • Colorado Clinical Research โ€” Lakewood, Colorado
  • Stamford Hospital โ€” Stamford, Connecticut
  • Urology Specialists LLC โ€” Hialeah, Florida
  • Mayo Clinic - Division Of Hematology/oncology โ€” Jacksonville, Florida
  • Miami Cancer Institute at Baptist Health / Baptist Health Medical Group โ€” Miami, Florida
  • Advent Health โ€” Orlando, Florida
  • Emory University Winship Cancer Institute โ€” Atlanta, Georgia
  • University of Chicago โ€” Chicago, Illinois
  • Ochsner LSU Health Shreveport - Regional Urology โ€” Shreveport, Louisiana
  • Dana Farber Cancer Institute โ€” Boston, Massachusetts
  • Beth Isreal Deaconess Medical Center โ€” Boston, Massachusetts
  • Michigan Institute of Urology, PC โ€” Troy, Michigan
  • Saint Louis University โ€” St Louis, Missouri
  • Urology Cancer Center, PC โ€” Omaha, Nebraska
  • Albany Medical College โ€” Albany, New York
  • Great Lakes Physician PC d/b/a Western New York Urology Associates โ€” Cheektowaga, New York
  • Memorial Sloan-Kettering Cancer Center โ€” New York, New York
  • Weill Cornell Medical College โ€” New York, New York

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—