Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )

Study Overview
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Brief Summary
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Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.

Detailed Description
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This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.

Official Title
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Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223

Conditions
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Prostatic Neoplasms, Castration-Resistant

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart. Patients were at least 18 years of age as of the first diagnosis for mCRPC. Patients must have received at least one intravenous injection of Radium-223 (Xofigo). First injection of Radium-223 must have started between periods 1-January-2014 to 30-June-2014 or 15-November-2014 to present. Patients must have a minimum of 12 months documented follow-up records following last Radium-223 treatment or death within 12 months of last dose. Exclusion Criteria: Patients who received Radium-223 as part in an interventional clinical trial Actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Radium-223 dichloride<br>Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC), at least 18 years of age, must have received at least one intravenous injection of Radium-223. | Drug: Xofigo (Radium-223 dichloride, BAY88-8223)<br>* Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining factors that drive physician decision for treatment selection. | The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD), testosterone, pain, symptoms, bone lesions, disease progression. | Up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Most common treatment sequences | Description of what treatments are given to treat mCRPC in first, second, third, and fourth line. | Up to 9 months | 
| Integration of Xofigo into the common treatment sequences, monotherapy or in combination. | Describe where is Xofigo given in the treatment paradigm, whether is given in combination with hormonals or chemotherapy or given as a monotherapy | Up to 9 months | 
| Mean Xofigo dose | Mean dose of each treatment received in the respective sequence | Up to 9 months | 
| Duration of Xofigo treatment | Mean number of treatment cycles | Up to 9 months | 
| Overall survival (OS) | Collect outcomes for patients following treatment for mCRPC including changes in overall survival | Up to 9 months | 
| Time to radiographic progression | Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression | Up to 9 months | 
| Time to PSA (Prostate specific antigen) progression | Collect outcomes for patients following treatment for mCRPC including changes in PSA progression | Up to 9 months | 
| Most common SRE (Skeletal Related Event) | The SRE occurring in the highest number of participants will be described. | Up to 9 months | 
| Most common clinical intervention | Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery. | Up to 9 months | 
| Time to first SSE(Symptomatic Skeletal Events) | Time to first SSE outcome will be analysed using the Kaplan Meier method | Up to 9 months | 
| Reasons for discontinuation | The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD)), testosterone, pain, symptoms, bone lesions, disease progression. | Up to 9 months | 
| Change in laboratory values from baseline | for hemoglobin, platelets, neutrophils | Up to 9 months | 
| Radiological progression free survival (rPFS) | change in laboratory values from baseline for radiological progression free survival (rPFS) | Up to 9 months | 
| Time to alkaline phosphatase (ALP) progression | change in laboratory values from baseline for ALP | Up to 9 months | 
| Time to visceral metastasis | time from baseline to the appearance of visceral metastasis | Up to 9 months | 
| Time to onset of first subsequent treatment | or start of any other treatment for mCRPC | Up to 9 months | 
| Pain | Based on chart reported pain | Up to 9 months | 
| Most common symptoms | The participant and the treating physician should select out of the following list: fatigue, hypertension, cognitive disorder, seizures, edema, hypokalemia, cardiac disorders, hepatotoxicity, anemia, neutropenia, febrile neutropenia, thrombocytopenia | Up to 9 months | 
| Type of physician | Define type of physicians that treat of mCRPC | Up to 9 months | 
| Change in PSA from baseline to 12 weeks, and baseline to discontinuation | Measure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation | Baseline and 12 weeks,Baseline and through study completion, an average of 1 year | 
| Resource utilization | Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations | Up to 9 months | 
| Change in ALP from baseline to 12 weeks, and baseline to discontinuation | Measure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation | Baseline and 12 weeks,Baseline and through study completion, an average of 1 year | 
| Change in LDH from baseline to 12 weeks, and baseline to discontinuation | Measure LDH values closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation | Baseline and 12 weeks,Baseline and through study completion, an average of 1 year |