๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-03

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer (NCT04464226)

An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

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

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

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

Who can join: Review the eligibility criteria below.

Location: Urology Centers of Alabama, PC - Homewood โ€” Homewood, Alabama

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 (335 Sites)

Showing the first 25 of 335 sites.

  • Urology Centers of Alabama, PC - Homewood โ€” Homewood, Alabama
  • Ironwood Cancer and Research Centers - Chandler I โ€” Chandler, Arizona
  • Tower Urology โ€” Los Angeles, California
  • Stanford Cancer Center Palo Alto โ€” Palo Alto, California
  • San Diego Clinical Trials โ€” San Diego, California
  • TOI Clinical Research โ€” Whittier, California
  • Rocky Mountain Regional VA Medical Center - Oncology โ€” Aurora, Colorado
  • The Urology Center Of Colorado โ€” Denver, Colorado
  • Boca Raton Regional Hospital - Oncology โ€” Boca Raton, Florida
  • Jesse Brown VA Medical Center - Cardiology โ€” Chicago, Illinois
  • Illinois CancerCare - Peoria โ€” Peoria, Illinois
  • Norton Cancer Institute - Downtown โ€” Louisville, Kentucky
  • Chesapeake Urology Associates - Towson โ€” Baltimore, Maryland
  • Johns Hopkins Hospital - Pulmonology โ€” Baltimore, Maryland
  • TidalHealth Peninsula Regional, Inc. - Oncology โ€” Salisbury, Maryland
  • Henry Ford Hospital - OB/GYN โ€” Detroit, Michigan
  • St. Vincent Regional Hospital - Oncology โ€” Billings, Montana
  • XCancer Omaha โ€” Omaha, Nebraska
  • New Jersey Urology - Voorhees โ€” Voorhees Township, New Jersey
  • New Mexico Cancer Center - Albuquerque โ€” Albuquerque, New Mexico
  • URMC Wilmot Cancer Center โ€” Rochester, New York
  • New York Cancer & Blood Specialists - Eastchester โ€” The Bronx, New York
  • Montefiore Einstein Center for Cancer Care - Tower at Montefiore Medical Park โ€” The Bronx, New York
  • Gabrail Cancer Center โ€” Canton, Ohio
  • The Urology Group - Norwood Surgery Center โ€” Cincinnati, Ohio

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 Cancer clinical trials

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†—