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In this study researcher want to learn more about the overall survival in patients suffering from prostate gland cancer which spread outside the prostate to other parts of the body who received either a novel anti-hormone therapy (NAH) or Radium-223 (Xofigo) after a prior NAH therapy (first line treatment). Additionally the researchers are also interested in the occurrence of bone fractures and other skeletal events. Basis for this study will be the US based Flatiron database which provides access to clinical data for cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort_2LX | Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as first liine (1L) after diagnosis of mCRPC who then received Ra-223 monotherapy as second line (2L) treatment |
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| Cohort_2LH | Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as 1L after diagnosis of mCRPC who then received another NAH monotherapy (i.e., Abiraterone to Enzalutamide or Enzalutamide to Abiraterone) as 2L treatment. None of the patients had ever received Radium-223 dichloride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223 (Xofigo, BAY88-8223) | Drug | Ra-223 was approved by the FDA in May 2013 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy | Retrospective analysis from 2013-01-01 to 2018-12-30 | |
| Overall survival (OS) from initiation of 2L therapy of sequential NAH in patients with mCRPC after 1L NAH therapy | Retrospective analysis from 2013-01-01 to 2018-12-30 |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analysis of patient demography at baseline | Demographic characteristics includes:
| Retrospective analysis from 2013-01-01 to 2018-12-30 |
| Descriptive analysis of clinical characteristics of patients at baseline |
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Inclusion Criteria:
Exclusion criteria:
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The primary study population consists of patients with documented mCRPC who either received Ra-223 or sequential NAH therapy after 1L NAH therapy respectively.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Flatiron prostate cancer database | Whippany | New Jersey | 07981 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34636627 | Result | Sartor O, George D, Tombal B, Agarwal N, Higano CS, Sternberg CN, Miller K, Jiao X, Guo H, Sandstrom P, Bruno A, Verholen F, Saad F, Shore N. Real-world outcomes of second novel hormonal therapy or radium-223 following first novel hormonal therapy for mCRPC. Future Oncol. 2022 Jan;18(1):35-45. doi: 10.2217/fon-2021-0886. Epub 2021 Oct 12. |
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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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| Abiraterone | Drug | Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018. |
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| Enzalutamide | Drug | Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy. |
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Clinical characteristics includes:
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| Retrospective analysis from 2013-01-01 to 2018-12-30 |
| Descriptive analysis of laboratory values at baseline | The laboratory tests of interest includes:
| Retrospective analysis from 2013-01-01 to 2018-12-30 |
| Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L | SSE:Symptomatic skeletal event | Retrospective analysis from 2013-01-01 to 2018-12-30 |
| Incidence rate of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L | Retrospective analysis from 2013-01-01 to 2018-12-30 |
| Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L | Retrospective analysis from 2013-01-01 to 2018-12-30 |
| Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L | Retrospective analysis from 2013-01-01 to 2018-12-30 |
| Period of time from initiation of 2L to first SSE | Retrospective analysis from 2013-01-01 to 2018-12-30 |
| ID | Term |
|---|---|
| C000615150 | Radium-223 |
| C581106 | radium Ra 223 dichloride |
| C089740 | abiraterone |
| C540278 | enzalutamide |
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