๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-04

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (NCT04136353)

DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: University of Sydney

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

The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence.

Who can join: Review the eligibility criteria below.

Location: Dana-Farber Cancer Institute โ€” Boston, Massachusetts

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 (93 Sites)

Showing the first 25 of 93 sites.

  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • Dana Farber Cancer Institute - St. Elizabeth's โ€” Brighton, Massachusetts
  • Lahey Hospital and Medical Center โ€” Burlington, Massachusetts
  • Dana Farber Cancer Institute - Milford โ€” Milford, Massachusetts
  • XCancer Omaha/Urology Cancer Center โ€” Omaha, Nebraska
  • Memorial Sloan Kettering Basking Ridge โ€” Basking Ridge, New Jersey
  • New Jersey Urology Saddle Brook โ€” Clifton, New Jersey
  • Memorial Sloan Kettering Monmouth โ€” Middletown, New Jersey
  • Memorial Sloan Kettering Bergen โ€” Montvale, New Jersey
  • New Jersey Urology Voorhees โ€” Voorhees Township, New Jersey
  • New Mexico Oncology and Hematology Specialists โ€” Albuquerque, New Mexico
  • Memorial Sloan Kettering Commack โ€” Commack, New York
  • Memorial Sloan Kettering Westchester โ€” Harrison, New York
  • New York University Langone Long Island โ€” Mineola, New York
  • New York University Langone Medical Center โ€” New York, New York
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Memorial Sloan Kettering Nassau โ€” Uniondale, New York
  • Dayton Physicians Network โ€” Kettering, Ohio
  • Seattle Cancer Care Alliance โ€” Seattle, Washington
  • Border Medical Oncology Research Unit โ€” Albury, New South Wales
  • Gosford Hospital โ€” Gosford, New South Wales
  • GenesisCare Newcastle โ€” Newcastle, New South Wales
  • Calvary Mater Newcastle โ€” Newcastle, New South Wales
  • Shoalhaven District Memorial Hospital โ€” Nowra, New South Wales
  • St Vincent's Public Hospital โ€” Sydney, New South Wales

๐Ÿ“ž Contact the Study Coordinator

Phone: (877) 338-7425

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

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.

Explore by condition: All Prostate Cancer clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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†—