ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT04464226

Public ClinicalTrials.gov record NCT04464226. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 22, 2026, 2:53 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT04464226
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
402 participants

Conditions and interventions

Conditions

Interventions

  • Darolutamide (Nubeqa, BAY1841788) Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 19, 2020
Primary completion
Jun 25, 2028
Completion
Jun 25, 2028
Last update posted
Apr 14, 2026

2020 – 2028

United States locations

U.S. sites
36
U.S. states
22
U.S. cities
34
Facility City State ZIP Site status
Urology Centers of Alabama, PC - Homewood Homewood Alabama 35209
Ironwood Cancer and Research Centers - Chandler I Chandler Arizona 85224
Tower Urology Los Angeles California 90048
Stanford Cancer Center Palo Alto Palo Alto California 94304
San Diego Clinical Trials San Diego California 92120
TOI Clinical Research Whittier California 90603
Rocky Mountain Regional VA Medical Center - Oncology Aurora Colorado 80045
The Urology Center Of Colorado Denver Colorado 80211
Boca Raton Regional Hospital - Oncology Boca Raton Florida 33486
Jesse Brown VA Medical Center - Cardiology Chicago Illinois 60612
Illinois CancerCare - Peoria Peoria Illinois 61615
Norton Cancer Institute - Downtown Louisville Kentucky 40202
Chesapeake Urology Associates - Towson Baltimore Maryland 21204
Johns Hopkins Hospital - Pulmonology Baltimore Maryland 21287
TidalHealth Peninsula Regional, Inc. - Oncology Salisbury Maryland 21801
Henry Ford Hospital - OB/GYN Detroit Michigan 48202
St. Vincent Regional Hospital - Oncology Billings Montana 59102
XCancer Omaha Omaha Nebraska 68130
New Jersey Urology - Voorhees Voorhees Township New Jersey 08043
New Mexico Cancer Center - Albuquerque Albuquerque New Mexico 87109
URMC Wilmot Cancer Center Rochester New York 14642
New York Cancer & Blood Specialists - Eastchester The Bronx New York 10469
Montefiore Einstein Center for Cancer Care - Tower at Montefiore Medical Park The Bronx New York 14061
Gabrail Cancer Center Canton Ohio 44718
The Urology Group - Norwood Surgery Center Cincinnati Ohio 45212
The Ohio State University - Arthur G James Cancer Hospital and Richard J Solove Research Institute Columbus Ohio 43210
MidLantic Urology - Bala Cynwyd Bala-Cynwyd Pennsylvania 19004
Andrews & Patel Associates Camp Hill Pennsylvania 17011
Charleston Oncology - Downtown Charleston South Carolina 29403
Carolina Urological Research Center Myrtle Beach South Carolina 29579
Urology Associates, PC - Nashville Nashville Tennessee 37209
Urology Clinics of North Texas - Dallas (Walnut HIll Lane) Dallas Texas 75231
Huntsman Cancer Institute Salt Lake City Utah 84112
VCU Health Ambulatory Care Center - Cardiology Richmond Virginia 23284
Providence Regional Cancer Partnership Everett Washington 98201
Inova Schar Cancer Insitute - Inova Fairfax Hospital Fairfax Washington 22031

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 299 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04464226, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 14, 2026 · Synced Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04464226 live on ClinicalTrials.gov.

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