Multi-academic Center Study of Xofigo Patients

Study Overview
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Brief Summary
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The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide. The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.

Official Title
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A Retrospective, Longitudinal Multi-Center Study of Radium-223 in Patients With Metastatic Castration-Resistant Prostate Cancer

Conditions
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Prostate Cancer, Castration Resistant

Intervention / Treatment
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* Drug: Xofigo
* Drug: Taxotere
* Drug: Jevtana


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received at least one dose of radium-223 after mCRPC diagnosis Received at least one prescription or dose of chemotherapy for treatment of mCRPC Exclusion Criteria: - No documented visceral metastasis at initiation of radium-223

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 |
| --- | --- |
| Ra-223 therapy before chemotherapy<br>Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy | Drug: Xofigo<br>* Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection<br>Drug: Taxotere<br>* Docetaxel injection 75mg/m2 every 3 weeks<br>Drug: Jevtana<br>* Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks<br>|
| Ra-223 after chemotherapy<br>Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy | Drug: Xofigo<br>* Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection<br>Drug: Taxotere<br>* Docetaxel injection 75mg/m2 every 3 weeks<br>Drug: Jevtana<br>* Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause). | Up to 30 months | 
| Time to symtomatic skeletal event(SSE) | Measured as the time from initiation of first-line therapy after mCRPC diagnosis until first SSE; for the exploratory analysis, measured as the time from initiation of radium-223 until first SSE. SSE will be identified based on the ALSYMPCA trial definition: first use of external-beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention | Up to 30 months | 
| Reasons for treatment discontinuation | data for treatment discontinuation for each mCRPC therapy will be collected | Up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory-based outcomes collected by questionnaire | Data will be collected as available from initiation of docetaxel until 3 months following last dose of docetaxel | Up to 30 months | 
| Treatments received | measured as Yes/No | Up to 30 months | 
| Number of hospitalizations | along with the discharge diagnosis, as recorded in medical charts or discharge summaries | Up to 30 months | 
| PSA PFS | defined as death or an increase above PSA nadir by ≥25% and ≥2 ng/mL (PCWG 2008 definition for Prostate specific antigen(PSA) Progression-free survival(PFS)) | Up to 30 months | 
| Non-laboratory based clinically relevant safety outcomes | documented in medical records | Up to 30 months | 
| hospital length of stay |  | Up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Bone metastases, Xofigo