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
Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients
1 other identifier
observational
805
17 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
January 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2026
ExpectedJune 26, 2026
June 1, 2026
6.4 years
October 9, 2019
June 25, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Occurrence of treatment-emergent adverse events (TEAEs)
Including severity, seriousness and outcome.
Up to 30 days after last dose of darolutamide within the patient's observation period
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
Dose modifications and time periods
Up to 30 days after last dose of darolutamide within the patient's observation period
Secondary Outcomes (15)
Subject's demographics
Up to 7 years
Subject's characteristics
Up to 7 years
Co-morbidities
Up to 7 years
Disease course and progression (including performance status)
Up to 7 years
Concomitant medication/treatment (including opioids)
Up to 7 years
- +10 more secondary outcomes
Study Arms (1)
Men with nmCRPC
Men with nmCRPC for whom a decision to treat with darolutamide has been made before enrollment, and who have signed informed consent, will be eligible for the study.
Interventions
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.
Eligibility Criteria
Male patients with a diagnosis of nmCRPC will be enrolled after the decision for treatment with darolutamide has been made by the investigator.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (41)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Arizona Institute of Urology
Tucson, Arizona, 85704, United States
Genesis Comprehensive Prostate Cancer Center
San Diego, California, 92123, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Manatee Medical Research Institute
Bradenton, Florida, 34205, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
Research by Design, LLC
Chicago, Illinois, 60643, United States
First Urology, PSC
Jeffersonville, Indiana, 47130, United States
Wichita Urology Group
Wichita, Kansas, 67206, United States
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719, United States
New Jersey Urology
Englewood, New Jersey, 07631, United States
Beacon Cancer Care
Beacon, New York, 83814, United States
Integrated Medical Professionals, PLLC
North New Hyde Park, New York, 11042, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12603, United States
Associated Medical Professional Urology
Syracuse, New York, 13210, United States
Dukes Cancer Intitute Center for Prostate and Urologic Cancers
Durham, North Carolina, 27710, United States
Associated Urologists of NC
Raleigh, North Carolina, 27612, United States
Oregon Urology Institutue
Springfield, Oregon, 01106, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17601, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
University of Washington
Seattle, Washington, 98101, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405, United States
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2019
First Posted
October 10, 2019
Study Start
January 30, 2020
Primary Completion
July 7, 2026
Study Completion (Estimated)
October 7, 2026
Last Updated
June 26, 2026
Record last verified: 2026-06