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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men with nmCRPC | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darolutamide(Nubeqa, BAY1841788) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment-emergent adverse events (TEAEs) | Including severity, seriousness and outcome. | 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) | 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 | Up to 30 days after last dose of darolutamide within the patient's observation period |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's demographics | Up to 7 years | |
| Subject's characteristics | Up to 7 years | |
| Co-morbidities |
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Inclusion Criteria:
Exclusion Criteria:
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Male patients with a diagnosis of nmCRPC will be enrolled after the decision for treatment with darolutamide has been made by the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | 35209 | United States | ||
| Arizona Institute of Urology |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| 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 |
| 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 | North 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 |
| Many Locations | Multiple Locations | Argentina |
| Many Locations | Multiple Locations | Austria |
| Many Locations | Multiple Locations | Belgium |
| Many Locations | Multiple Locations | Brazil |
| Many Locations | Multiple Locations | Canada |
| Many Locations | Multiple Locations | China |
| Many Locations | Multiple Locations | Colombia |
| Many Locations | Multiple Locations | Denmark |
| Many Locations | Multiple Locations | France |
| Many Locations | Multiple Locations | Germany |
| Many Locations | Multiple Locations | Greece |
| Many Locations | Multiple Locations | Italy |
| Many Locations | Multiple Locations | Japan |
| Many Locations | Multiple Locations | Russia |
| Many Locations | Multiple Locations | Spain |
| Many Locations | Multiple Locations | Taiwan |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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