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

Running, not enrolling

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04122976

Run by

Bayer

People needed

805

Starts

2020-01-30

Expected to finish

2026-10-07

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• New Jersey Urology — Englewood, 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
• Oregon Urology Institute — Springfield, Massachusetts, United States
• Beacon Cancer Care — Beacon, New York, United States
• Integrated Medical Professionals, PLLC — North 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
• Associated Urologists of NC — Raleigh, North Carolina, United States
• Keystone Urology Specialists — Lancaster, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Urology San Antonio — San Antonio, Texas, 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, Argentina

Full record on ClinicalTrials.gov

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