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
- Conditions
- Prostate Cancer
- Interventions
- Drug: Darolutamide(Nubeqa, BAY1841788)
- Registration Number
- NCT04122976
- Lead Sponsor
- Bayer
- 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 805
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Men with nmCRPC Darolutamide(Nubeqa, BAY1841788) Men with nmCRPC for whom a decision to treat with darolutamide has been made before enrollment, and who have signed informed consent, will be eligible for the study.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Subject's demographics Up to 7 years Subject's characteristics Up to 7 years Co-morbidities Up to 7 years Disease course and progression (including performance status) Up to 7 years Concomitant medication/treatment (including opioids) Up to 7 years Dosage and dose modification of darolutamide Up to 7 years Reasons for ending treatment and/or observation/follow-up Up to 7 years Metastasis-Free Survival (MFS) Up to 7 years Time to Symptomatic Skeletal Event (TSSE) Up to 7 years Time to Prostate-Specific Antigen (PSA) progression Up to 7 years Survival rate Up to 7 years Duration of darolutamide therapy Up to 7 years Imaging exams used to define tumor status Up to 7 years Imaging exams (as chosen by treating physician) used to diagnose nmCRPC (including date and clinical finding) Up to 7 years Prior and post - darolutamide treatments for prostate cancer Up to 7 years
Trial Locations
- Locations (26)
Urology San Antonio
🇺🇸San Antonio, Texas, United States
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
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
New Jersey Urology
🇺🇸Englewood, New Jersey, United States
Beacon Cancer Care
🇺🇸Beacon, New York, United States
Integrated Medical Professionals, PLLC
🇺🇸N. New Hyde Park, New York, United States
Premier Medical Group of the Hudson Valley, PC
🇺🇸Poughkeepsie, New York, United States
Associated Medical Professional Urology
🇺🇸Syracuse, New York, United States
Dukes Cancer Intitute Center for Prostate and Urologic Cancers
🇺🇸Durham, North Carolina, United States
Associated Urologists of NC
🇺🇸Raleigh, North Carolina, United States
Oregon Urology Institutue
🇺🇸Springfield, Oregon, United States
Keystone Urology Specialists
🇺🇸Lancaster, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor Scott & White Medical Center - Temple
🇺🇸Temple, Texas, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
MultiCare Institute for Research & Innovation
🇺🇸Tacoma, Washington, United States
Many Locations
🇨🇳Multiple Locations, Taiwan