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ClinicalTrials.gov record
Active, not recruiting No phase listed Observational

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

ClinicalTrials.gov ID: NCT04122976

Public ClinicalTrials.gov record NCT04122976. 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 Sep 19, 2026, 7:55 AM EDT

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

Official title

Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04122976
Recruitment status
Active, not recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Bayer
Industry
Enrollment
805 participants

Conditions and interventions

Interventions

Drug

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
Jan 29, 2020
Primary completion
Jul 19, 2026
Completion
Oct 6, 2026
Last update posted
Aug 5, 2026

2020 – 2026

United States locations

U.S. sites
24
U.S. states
16
U.S. cities
24
Facility City State ZIP Site status
Urology Centers of Alabama Homewood Alabama 35209
Arizona Institute of Urology Tucson Arizona 85704
Genesis Comprehensive Prostate Cancer Center San Diego California 92123
The Urology Center of Colorado Denver Colorado 80211
New Jersey Urology Englewood Colorado 07631
Manatee Medical Research Institute Bradenton Florida 34205
Advanced Urology Institute Daytona Beach Florida 32114
Research by Design, LLC Chicago Illinois 60643
First Urology, PSC Jeffersonville Indiana 47130
Wichita Urology Group Wichita Kansas 67206
Southcoast Centers for Cancer Care Fairhaven Massachusetts 02719
Oregon Urology Institute Springfield Massachusetts 01106
Beacon Cancer Care Beacon New York 83814
Integrated Medical Professionals, PLLC North New Hyde Park New York 11042
Premier Medical Group of the Hudson Valley, PC Poughkeepsie New York 12603
Associated Medical Professional Urology Syracuse New York 13210
Associated Urologists of NC Raleigh North Carolina 27612
Keystone Urology Specialists Lancaster Pennsylvania 17601
Vanderbilt University Medical Center Nashville Tennessee 37203
Urology San Antonio San Antonio Texas 78229
Baylor Scott & White Medical Center - Temple Temple Texas 76508
Urology of Virginia Virginia Beach Virginia 23462
University of Washington Seattle Washington 98101
MultiCare Institute for Research & Innovation Tacoma Washington 98405

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 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04122976, 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 Aug 5, 2026 · Synced Sep 19, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04122976 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →