Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer (NCT04464226)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (4 items).
Location: Urology Centers of Alabama, PC - Homewood — Homewood, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participant is unable to comply with the requirements of the study.
- Negative benefit/ risk ratio as determined by the investigator.
- Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (335 Sites)
- Urology Centers of Alabama, PC - Homewood — Homewood, Alabama
- Ironwood Cancer and Research Centers - Chandler I — Chandler, Arizona
- Tower Urology — Los Angeles, California
- Stanford Cancer Center Palo Alto — Palo Alto, California
- San Diego Clinical Trials — San Diego, California
- TOI Clinical Research — Whittier, California
- Rocky Mountain Regional VA Medical Center - Oncology — Aurora, Colorado
- The Urology Center Of Colorado — Denver, Colorado
- Boca Raton Regional Hospital - Oncology — Boca Raton, Florida
- Jesse Brown VA Medical Center - Cardiology — Chicago, Illinois
- Illinois CancerCare - Peoria — Peoria, Illinois
- Norton Cancer Institute - Downtown — Louisville, Kentucky
- Chesapeake Urology Associates - Towson — Baltimore, Maryland
- Johns Hopkins Hospital - Pulmonology — Baltimore, Maryland
- TidalHealth Peninsula Regional, Inc. - Oncology — Salisbury, Maryland
- Henry Ford Hospital - OB/GYN — Detroit, Michigan
- St. Vincent Regional Hospital - Oncology — Billings, Montana
- XCancer Omaha — Omaha, Nebraska
- New Jersey Urology - Voorhees — Voorhees Township, New Jersey
- New Mexico Cancer Center - Albuquerque — Albuquerque, New Mexico
- URMC Wilmot Cancer Center — Rochester, New York
- New York Cancer & Blood Specialists - Eastchester — The Bronx, New York
- Montefiore Einstein Center for Cancer Care - Tower at Montefiore Medical Park — The Bronx, New York
- Gabrail Cancer Center — Canton, Ohio
- The Urology Group - Norwood Surgery Center — Cincinnati, Ohio
💰 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 § 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.