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Active, not recruiting 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

NCT04122976 · tracked via the Priya Life Science Belgium tracker
Sponsor
Phase
Observational
Started
2020-01-30
Last updated
2026-08-06

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Darolutamide(Nubeqa, BAY1841788) →

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.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Occurrence of treatment-emergent adverse events (TEAEs) — Up to 30 days after last dose of darolutamide within the patient's observation period
    Including severity, seriousness and outcome.
  • 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 — Up to 30 days after last dose of darolutamide within the patient's observation period
    Dose modifications and time periods

Trial sites (40)

FacilityCityRegionStatus
Urology Centers of Alabama Homewood Alabama
Arizona Institute of Urology Tucson Arizona
Genesis Comprehensive Prostate Cancer Center San Diego California
The Urology Center of Colorado Denver Colorado
New Jersey Urology Englewood Colorado
Manatee Medical Research Institute Bradenton Florida
Advanced Urology Institute Daytona Beach Florida
Research by Design, LLC Chicago Illinois
First Urology, PSC Jeffersonville Indiana
Wichita Urology Group Wichita Kansas
Southcoast Centers for Cancer Care Fairhaven Massachusetts
Oregon Urology Institute Springfield Massachusetts
Beacon Cancer Care Beacon New York
Integrated Medical Professionals, PLLC North New Hyde Park New York
Premier Medical Group of the Hudson Valley, PC Poughkeepsie New York
Associated Medical Professional Urology Syracuse New York
Associated Urologists of NC Raleigh North Carolina
Keystone Urology Specialists Lancaster Pennsylvania
Vanderbilt University Medical Center Nashville Tennessee
Urology San Antonio San Antonio Texas
Baylor Scott & White Medical Center - Temple Temple Texas
Urology of Virginia Virginia Beach Virginia
University of Washington Seattle Washington
MultiCare Institute for Research & Innovation Tacoma Washington
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04122976 on ClinicalTrials.gov ↗ ← All trials in Belgium