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

Prostate Cancer Clinical Trial

— DAROL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04122976
• Other study ID #: 20590
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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