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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 Nov 3, 2026, 5:20 PM EST

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 30, 2020 (Actual)
Primary completion
Jul 20, 2026 (Actual)
Completion
Oct 7, 2026 (Estimated)
Last update posted
Aug 6, 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 6, 2026 · Synced Nov 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04122976 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →