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.

Basic information

Official Title: Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients
Trial ID: NCT04122976
Status: Recruiting
Last Known Status: Not Available from clinicaltrials.gov

Trial Phase: Not Available from clinicaltrials.gov

Keywords: Not Available from clinicaltrials.gov

Subjects

Age (Minimum Eligibility): 18 Years
Age (Maximum Eligibility):
Gender: Male
Healthy Subject(s): 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