Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo).

Study Overview
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Brief Summary
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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.

Official Title
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DescriPtive Analysis of Real-world Clinical Outcomes of Second Line (2L) Novel Anti-HormonE Therapy (NAH) or RadIum-223 (Xofigo) in Patients With Metastatic Castration Resistance Prostate Cancer (mCRPC) After First Line (1L) NAH Therapy

Conditions
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Metastatic Castration-resistant Prostate Cancer (mCRPC)

Intervention / Treatment
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* Drug: Radium-223 (Xofigo, BAY88-8223)
* Drug: Abiraterone
* Drug: Enzalutamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with documented mCRPC receiving 1L NAHs. Initiation of Ra-223 after 1L NAH therapy, or Initiation of sequential NAH therapy after 1L NAH therapy Exclusion criteria: Patients involved in clinical trials Patients who received combined therapies in 1L or 2L
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort_2LX<br>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 | Drug: Radium-223 (Xofigo, BAY88-8223)<br>* 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.<br>Drug: Abiraterone<br>* 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.<br>Drug: Enzalutamide<br>* 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.<br>|
| Cohort_2LH<br>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 | Drug: Abiraterone<br>* 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.<br>Drug: Enzalutamide<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analysis of patient demography at baseline | Demographic characteristics includes: Gender (expecting 100% male) Age (in the year of index date) Ethnicity | Retrospective analysis from 2013-01-01 to 2018-12-30 | 
| Descriptive analysis of clinical characteristics of patients at baseline | Clinical characteristics includes: Histology Gleason score Clinical stage (at initial diagnosis) T/N/M stage (at initial diagnosis) ECOG performance status Site of metastasis (visceral, lymph node, bone) | Retrospective analysis from 2013-01-01 to 2018-12-30 | 
| Descriptive analysis of laboratory values at baseline | The laboratory tests of interest includes: Prostate Specific Antigen(PSA) Alkaline Phosphatase(ALP) Hemoglobin (Hgb) Lactate dehydrogenase (LDH) | 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 |