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This is an observational cohort study in men with non-metastatic castration-resistant prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide.
The main purpose of this study is to collect data on the length of time men with nmCRPC continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their doctors. Researchers will only include men who had not been treated with any new type of medication that blocks the action of hormones.
The data will come from an electronic health record database called Precision Point Specialty (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of America. EMR data will be verified and supplemented via patient chart review. Data collected will be from January 2019 to September 2023. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apalutamide |
| ||
| Darolutamide |
| ||
| Enzalutamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apalutamide | Drug | Decision by the treating physician |
| |
| Darolutamide (BAY 1841788) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to ARI treatment discontinuation | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for ARI treatment discontinuation | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 | |
| Proportion of patients, who switched to another ARI therapy | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult men previously not treated with a novel antihormonal agent and starting the initial ARI treatment for nmCRPC during the study period, in US community urology practices
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bayer | Whippany | New Jersey | 07981 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41851476 | Derived | Shore ND, George DJ, Khan N, Constantinovici N, Chen G, Ghadessi M, Hlebec V, Morgans AK. Real-world analysis of androgen receptor inhibitors in US patients with nonmetastatic castration-resistant prostate cancer: DEAR-EXT study. Prostate Cancer Prostatic Dis. 2026 Mar 18. doi: 10.1038/s41391-026-01099-3. Online ahead of print. |
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Availability of this study's data will later 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.vivli.org 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 member section of the portal.
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| Drug |
Decision by the treating physician |
|
|
| Enzalutamide | Drug | Decision by treating physician |
|
| Frequency of adverse events | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
| Time to progression to mCRPC | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
| Dose modification of initial ARI | Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 |
| ID | Term |
|---|---|
| C572045 | apalutamide |
| C000607739 | darolutamide |
| C540278 | enzalutamide |
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