Trial Condition(s):

Prostate Cancer

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 (DAROL)

Bayer Identifier:

20590

ClinicalTrials.gov Identifier:

NCT04122976

EudraCT Number:

Not Available

EU CT Number:

Not Available

Recruiting

Trial Purpose

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.

Inclusion Criteria
- Men over the age of 18 years
- Histologically or cytologically confirmed adenocarcinoma CRPC defined by disease progression despite ADT and may present as a confirmed rise in serum PSA levels (as defined by PCWG3: Rising PSA values at a minimum of 1-week intervals, and a baseline PSA value ≥ 1.0 ng/mL). For patients with a prior ARi treatment (Enzalutamide or Apalutamide), there is no baseline PSA value required
- No evidence of metastasis based on conventional imaging. An imaging assessment needs to be obtained prior to the 1st dose of darolutamide. For patients with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC, M0 status with no evidence of disease progression should be confirmed within 3 months of ARi discontinuation
- Decision to initiate treatment with darolutamide was made as per investigator’s routine treatment practice prior to enrollment in the study
- Signed informed consent
- Life expectancy of ≥3 months
- For a patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for less than one year, all toxic effects from prior use of any ARi treatment have to be resolved at the time of enrollment and prior to the 1st dose of darolutamide
Exclusion Criteria
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to the local marketing authorization 
- Previous treatment with darolutamide (more than 3 days prior to enrollment)
- Patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for more than one year

Trial Summary

Enrollment Goal
800
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Argentina

Status
Recruiting
Locations

Many Locations

Many Locations, Austria

Status
Recruiting
Locations

Many Locations

Many Locations, Australia

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Belgium

Status
Recruiting
Locations

Many Locations

Many Locations, Brazil

Status
Recruiting
Locations

Many Locations

Many Locations, Canada

Status
Recruiting
Locations

Many Locations

Many Locations, China

Status
Recruiting
Locations

Many Locations

Many Locations, Colombia

Status
Recruiting
Locations

Many Locations

Many Locations, Germany

Status
Recruiting
Locations

Many Locations

Many Locations, Denmark

Status
Terminated
Locations

Many Locations

Many Locations, Spain

Status
Recruiting
Locations

Many Locations

Many Locations, Finland

Status
Not yet recruiting
Locations

Many Locations

Many Locations, France

Status
Recruiting
Locations

Many Locations

Many Locations, United Kingdom

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Greece

Status
Recruiting
Locations

Many Locations

Many Locations, Hong Kong, China

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Ireland

Status
Not yet recruiting
Locations

Many Locations

Many Locations, India

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Italy

Status
Recruiting
Locations

Many Locations

Many Locations, Japan

Status
Recruiting
Locations

Many Locations

Many Locations, Mexico

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Netherlands

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Norway

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Russia

Status
Recruiting
Locations

Many Locations

Many Locations, Sweden

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Slovakia

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Turkey

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Taiwan, China

Status
Recruiting
Locations

Dukes Cancer Intitute Center for Prostate and Urologic Cancers

Durham, United States, 27710

Status
Recruiting
Locations

Arizona Institute of Urology

Tucson, United States, 85704

Status
Recruiting
Locations

Associated Medical Professional Urology

Syracuse, United States, 13210

Status
Recruiting
Locations

University of Washington

Seattle, United States, 98101

Status
Recruiting
Locations

Urology San Antonio

San Antonio, United States, 78229

Status
Recruiting
Locations

Urology Centers of Alabama

Homewood, United States, 35209

Status
Recruiting
Locations

First Urology, PSC

Jeffersonville, United States, 47130

Status
Recruiting
Locations

Keystone Urology Specialists

Lancaster, United States, 17601

Status
Recruiting
Locations

Wichita Urology Group

Wichita, United States, 67206

Status
Recruiting
Locations

Genesis Comprehensive Prostate Cancer Center

San Diego, United States, 92123

Status
Recruiting
Locations

New Jersey Urology

Englewood, United States, 07631

Status
Recruiting
Locations

Manatee Medical Research Institute

Bradenton, United States, 34205

Status
Recruiting
Locations

Associated Urologists of NC

Raleigh, United States, 27612

Status
Recruiting
Locations

Oregon Urology Institutue

Springfield, United States, 01106

Status
Recruiting
Locations

Vanderbilt University Medical Center

Nashville, United States, 37203

Status
Recruiting
Locations

Baylor Scott & White Medical Center - Temple

Temple, United States, 76508

Status
Recruiting
Locations

Urology of Virginia

Virginia Beach, United States, 23462

Status
Recruiting
Locations

Integrated Medical Professionals, PLLC

North New Hyde Park, United States, 11042

Status
Completed
Locations

Advanced Urology Institute

Daytona Beach, United States, 32114

Status
Recruiting
Locations

MultiCare Institute for Research & Innovation

Tacoma, United States, 98405

Status
Recruiting
Locations

Premier Medical Group of the Hudson Valley, PC

Poughkeepsie, United States, 12603

Status
Recruiting
Locations

Southcoast Centers for Cancer Care

Fairhaven, United States, 02719

Status
Recruiting
Locations

The Urology Center of Colorado

Denver, United States, 80211

Status
Recruiting
Locations

Beacon Cancer Care

Beacon, United States, 83814

Status
Recruiting
Locations

Research by Design, LLC

Chicago, United States, 60643

Status
Recruiting

Trial Design