A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described
Condition(s) studied
Investigational drug(s) / intervention(s)
Darolutamide(Nubeqa, BAY1841788): The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.
Study summary
The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.
Eligibility
Primary outcome measure(s)
- Occurrence of treatment-emergent adverse events (TEAEs) — Up to 30 days after last dose of darolutamide within the patient's observation period
Including severity, seriousness and outcome. - Reasonable causal relationship between darolutamide and an adverse event (AE) — Up to 30 days after last dose of darolutamide within the patient's observation period
- Action taken related to darolutamide treatment — Up to 30 days after last dose of darolutamide within the patient's observation period
Dose modifications and time periods
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | |
| Arizona Institute of Urology | Tucson | Arizona | |
| Genesis Comprehensive Prostate Cancer Center | San Diego | California | |
| The Urology Center of Colorado | Denver | Colorado | |
| New Jersey Urology | Englewood | Colorado | |
| Manatee Medical Research Institute | Bradenton | Florida | |
| Advanced Urology Institute | Daytona Beach | Florida | |
| Research by Design, LLC | Chicago | Illinois | |
| First Urology, PSC | Jeffersonville | Indiana | |
| Wichita Urology Group | Wichita | Kansas | |
| Southcoast Centers for Cancer Care | Fairhaven | Massachusetts | |
| Oregon Urology Institute | Springfield | Massachusetts | |
| Beacon Cancer Care | Beacon | New York | |
| Integrated Medical Professionals, PLLC | North New Hyde Park | New York | |
| Premier Medical Group of the Hudson Valley, PC | Poughkeepsie | New York | |
| Associated Medical Professional Urology | Syracuse | New York | |
| Associated Urologists of NC | Raleigh | North Carolina | |
| Keystone Urology Specialists | Lancaster | Pennsylvania | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| Urology San Antonio | San Antonio | Texas | |
| Baylor Scott & White Medical Center - Temple | Temple | Texas | |
| Urology of Virginia | Virginia Beach | Virginia | |
| University of Washington | Seattle | Washington | |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | |
| Many locations | Multiple Locations | Argentina | |
| Many locations | Multiple Locations | Austria | |
| Many locations | Multiple Locations | Belgium | |
| Many locations | Multiple Locations | Brazil | |
| Many locations | Multiple Locations | Canada | |
| Many locations | Multiple Locations | China | |
| Many locations | Multiple Locations | Colombia | |
| Many locations | Multiple Locations | Denmark | |
| Many locations | Multiple Locations | France | |
| Many locations | Multiple Locations | Germany | |
| Many locations | Multiple Locations | Greece | |
| Many locations | Multiple Locations | Italy | |
| Many locations | Multiple Locations | Japan | |
| Many locations | Multiple Locations | Russia | |
| Many locations | Multiple Locations | Spain | |
| Many locations | Multiple Locations | Taiwan |
More Bayer trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04122976 on ClinicalTrials.gov ↗ ← All trials in Belgium