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

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer (NCT04557059)

A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Janssen Pharmaceutica N.V., Belgium

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

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

Who can join: Review the eligibility criteria below.

Location: Arizona Urology Specialists โ€” Tucson, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

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 (141 Sites)

Showing the first 25 of 141 sites.

  • Arizona Urology Specialists โ€” Tucson, Arizona
  • Arkansas Urology โ€” Little Rock, Arkansas
  • Colorado Clinical Research โ€” Lakewood, Colorado
  • Urological Research Network โ€” Hialeah, Florida
  • First Urology, PSC โ€” Jeffersonville, Indiana
  • Michigan Institute of Urology โ€” Troy, Michigan
  • Associated Medical Professionals of Ny โ€” Syracuse, New York
  • The Urology Group โ€” Cincinnati, Ohio
  • Oregon Urology Institute โ€” Springfield, Oregon
  • MidLantic Urology โ€” Bala-Cynwyd, Pennsylvania
  • Urology Austin โ€” Austin, Texas
  • Houston Metro Urology โ€” Houston, Texas
  • Spokane Urology โ€” Spokane, Washington
  • Bundaberg Hospital โ€” Bundaberg,
  • Hervey Bay Hospital โ€” Bundaberg,
  • Epworth Healthcare โ€” East Melbourne,
  • St Vincent's Hospital - Melbourne โ€” Fitzroy,
  • Genesis Care Hurstville โ€” Hurstville,
  • Macquarie University Hospital โ€” North Ryde,
  • Calvary Mater Newcastle โ€” Waratah,
  • GenesisCare Wembley โ€” Wembley,
  • Ordensklinikum Linz GmbH Elisabethinen โ€” Linz,
  • Universitaetsklinikum Salzburg Landeskrankenhaus โ€” Salzburg,
  • Medizinische Universitaet Wien โ€” Vienna,
  • ZAS Augustinus โ€” Antwerp,

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†—