Trial Condition(s):

Prostate Cancer

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)

Bayer Identifier:

20590

ClinicalTrials.gov Identifier:

NCT04122976

EudraCT Number:

Not Available

Recruiting

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
800
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

First Urology, PSC

Jeffersonville, United States, 47130

Status
Recruiting
 

Trial Design