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.
Study Type
OBSERVATIONAL
Enrollment
805
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.
Urology Centers of Alabama
Homewood, Alabama, United States
Arizona Institute of Urology
Tucson, Arizona, United States
Genesis Comprehensive Prostate Cancer Center
San Diego, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Manatee Medical Research Institute
Bradenton, Florida, United States
Occurrence of treatment-emergent adverse events (TEAEs)
Including severity, seriousness and outcome.
Time frame: Up to 30 days after last dose of darolutamide within the patient's observation period
Reasonable causal relationship between darolutamide and an adverse event (AE)
Time frame: Up to 30 days after last dose of darolutamide within the patient's observation period
Action taken related to darolutamide treatment
Dose modifications and time periods
Time frame: Up to 30 days after last dose of darolutamide within the patient's observation period
Subject's demographics
Time frame: Up to 7 years
Subject's characteristics
Time frame: Up to 7 years
Co-morbidities
Time frame: Up to 7 years
Disease course and progression (including performance status)
Time frame: Up to 7 years
Concomitant medication/treatment (including opioids)
Time frame: Up to 7 years
Dosage and dose modification of darolutamide
Time frame: Up to 7 years
Reasons for ending treatment and/or observation/follow-up
Time frame: Up to 7 years
Metastasis-Free Survival (MFS)
Time frame: Up to 7 years
Time to Symptomatic Skeletal Event (TSSE)
Time frame: Up to 7 years
Time to Prostate-Specific Antigen (PSA) progression
Time frame: Up to 7 years
Survival rate
Time frame: Up to 7 years
Duration of darolutamide therapy
Time frame: Up to 7 years
Imaging exams used to define tumor status
Time frame: Up to 7 years
Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding)
Time frame: Up to 7 years
Prior and post - darolutamide treatments for prostate cancer
Time frame: Up to 7 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Advanced Urology Institute
Daytona Beach, Florida, United States
Research by Design, LLC
Chicago, Illinois, United States
First Urology, PSC
Jeffersonville, Indiana, United States
Wichita Urology Group
Wichita, Kansas, United States
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, United States
...and 31 more locations