Condition: Prostate Cancer · Sponsor: Bayer
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
+ 28 more locations — full list on the registry record.
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