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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04122976
Other study ID # 20590
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 30, 2020
Est. completion date October 7, 2026

Study information

Verified date June 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 805
Est. completion date October 7, 2026
Est. primary completion date July 7, 2026
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
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
Russian Federation Many Locations Multiple Locations
Spain Many Locations Multiple Locations
Taiwan Many Locations Multiple Locations
United States Beacon Cancer Care Beacon New York
United States Manatee Medical Research Institute Bradenton Florida
United States Research by Design, LLC Chicago Illinois
United States Advanced Urology Institute Daytona Beach Florida
United States The Urology Center of Colorado Denver Colorado
United States Dukes Cancer Intitute Center for Prostate and Urologic Cancers Durham North Carolina
United States New Jersey Urology Englewood New Jersey
United States Southcoast Centers for Cancer Care Fairhaven Massachusetts
United States Urology Centers of Alabama Homewood Alabama
United States First Urology, PSC Jeffersonville Indiana
United States Keystone Urology Specialists Lancaster Pennsylvania
United States Integrated Medical Professionals, PLLC N. New Hyde Park New York
United States Vanderbilt University Medical Center Nashville Tennessee
United States Premier Medical Group of the Hudson Valley, PC Poughkeepsie New York
United States Associated Urologists of NC Raleigh North Carolina
United States Urology San Antonio San Antonio Texas
United States Genesis Comprehensive Prostate Cancer Center San Diego California
United States University of Washington Seattle Washington
United States Oregon Urology Institutue Springfield Oregon
United States Associated Medical Professional Urology Syracuse New York
United States MultiCare Institute for Research & Innovation Tacoma Washington
United States Baylor Scott & White Medical Center - Temple Temple Texas
United States Arizona Institute of Urology Tucson Arizona
United States Urology of Virginia Virginia Beach Virginia
United States Wichita Urology Group Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Canada,  China,  Colombia,  Denmark,  France,  Germany,  Greece,  Italy,  Japan,  Russian Federation,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Subject's demographics Up to 7 years
Secondary Subject's characteristics Up to 7 years
Secondary Co-morbidities Up to 7 years
Secondary Disease course and progression (including performance status) Up to 7 years
Secondary Concomitant medication/treatment (including opioids) Up to 7 years
Secondary Dosage and dose modification of darolutamide Up to 7 years
Secondary Reasons for ending treatment and/or observation/follow-up Up to 7 years
Secondary Metastasis-Free Survival (MFS) Up to 7 years
Secondary Time to Symptomatic Skeletal Event (TSSE) Up to 7 years
Secondary Time to Prostate-Specific Antigen (PSA) progression Up to 7 years
Secondary Survival rate Up to 7 years
Secondary Duration of darolutamide therapy Up to 7 years
Secondary Imaging exams used to define tumor status Up to 7 years
Secondary Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding) Up to 7 years
Secondary Prior and post - darolutamide treatments for prostate cancer Up to 7 years
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