Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04464226
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 402 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
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
- Jul 6, 2026
2020 – 2028
United States locations
- U.S. sites
- 36
- U.S. states
- 21
- 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 | — |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | — |
| Inova Schar Cancer Insitute - Inova Fairfax Hospital | Fairfax | Washington | 22031 | — |
| VCU Health Ambulatory Care Center - Cardiology | Virginia | Washington | 23284 | — |
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 Jul 6, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04464226 live on ClinicalTrials.gov.