Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Bayer
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
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. Wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 7 2026
Estimated Enrollment :
805 Patients enrolled
Trial Details
Trial ID
NCT04122976
Start Date
January 30 2020
End Date
October 7 2026
Last Update
January 6 2026
Active Locations (41)
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1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
2
Arizona Institute of Urology
Tucson, Arizona, United States, 85704
3
Genesis Comprehensive Prostate Cancer Center
San Diego, California, United States, 92123
4
The Urology Center of Colorado
Denver, Colorado, United States, 80211