Prostate Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

805

Study ID:

NCT04122976

Recruitment Status:

Active, not recruiting

Sponsor:

Bayer

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There are 25 Locations for this study

See Locations Near You

Urology Centers of Alabama
Homewood Alabama, 35209, United States
Arizona Institute of Urology
Tucson Arizona, 85704, United States
Genesis Comprehensive Prostate Cancer Center
San Diego California, 92123, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Manatee Medical Research Institute
Bradenton Florida, 34205, United States
Advanced Urology Institute
Daytona Beach Florida, 32114, United States
Research by Design, LLC
Chicago Illinois, 60643, United States
First Urology, PSC
Jeffersonville Indiana, 47130, United States
Wichita Urology Group
Wichita Kansas, 67206, United States
Southcoast Centers for Cancer Care
Fairhaven Massachusetts, 02719, United States
New Jersey Urology
Englewood New Jersey, 07631, United States
Beacon Cancer Care
Beacon New York, 83814, United States
Integrated Medical Professionals, PLLC
N. New Hyde Park New York, 11042, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie New York, 12603, United States
Associated Medical Professional Urology
Syracuse New York, 13210, United States
Dukes Cancer Intitute Center for Prostate and Urologic Cancers
Durham North Carolina, 27710, United States
Associated Urologists of NC
Raleigh North Carolina, 27612, United States
Oregon Urology Institutue
Springfield Oregon, 01106, United States
Keystone Urology Specialists
Lancaster Pennsylvania, 17601, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37203, United States
Urology San Antonio
San Antonio Texas, 78229, United States
Baylor Scott & White Medical Center - Temple
Temple Texas, 76508, United States
Urology of Virginia
Virginia Beach Virginia, 23462, United States
University of Washington
Seattle Washington, 98101, United States
MultiCare Institute for Research & Innovation
Tacoma Washington, 98405, United States
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How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

805

Study ID:

NCT04122976

Recruitment Status:

Active, not recruiting

Sponsor:


Bayer

How clear is this clinincal trial information?

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