Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study

Study Overview
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Brief Summary
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There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. For the purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6 months from the start of first line abi/enza. The specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC patients treated with Ra-223 concomittantly with abi/enza in first line treatment.

Official Title
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Outcomes and Treatment Patterns of Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223 Concomitantly With Abiraterone or Enzalutamide in First Line Setting : A Retrospective Chart Abstraction Study

Conditions
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Prostatic Neoplasms, Castration-Resistant

Intervention / Treatment
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* Drug: radium Ra 223 dichloride (Xofigo, BAY88-8223)
* Drug: Zytiga
* Drug: Xtandi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of mCRPC and bone metastases ≥ 40 years of age at diagnosis of mCRPC Initiated first line treatment for mCRPC with abi/enza (use of sipuleucel-T prior to initiation of abi or enza is allowed) Receipt of at least one cycle of radium-223 after 15 May 2013 First cycle of Ra-223 occurs while receiving first line treatment with abi/enza Treated with abi/enza for at least 28 days (1 cycle) following initiation of Ra-223 Initiation of Ra-223 at least 6 months after the start of treatment with abi/enza Completion of Ra-223 treatment prior to the receipt of any chemotherapy for mCRPC At least 12 months of follow-up (or until death) from date of initiation of Ra-223 Known date of death (if patient deceased) Exclusion Criteria: Receipt of any prior chemotherapy during hormone sensitive disease or any time before mCPRC Active participant in an interventional clinical trial for CRPC in first line Presence of visceral metastases at initiation of Ra-223 treatment Treated with abi/enza (with or without docetaxel) prior to the development of metastatic and/or castration resistant disease

Ages Eligible for Study
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Minimum Age: 40 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 concomitant with Abiraterone or Enzalutamide<br>Approximately 150 medical charts from mCRPC patients within the network will be collected | Drug: radium Ra 223 dichloride (Xofigo, BAY88-8223)<br>* Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injections<br>Drug: Zytiga<br>* Abiraterone 1000 mg per day orally<br>Drug: Xtandi<br>* Enzalutamide 160 mg per day orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rates | Survival will be defined as time from initiation of first line therapy until death. Survival will be measured as the proportion of study subjects that are alive at the data cut-off or median time for survival of at least 50% of study subjects | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | Disease progression will be defined as either of the below: PSA (Prostate Specific Antigen) progression ALP (Alkaline Phosphatase) progression Symptomatic progression Radiographic progression | Up to 1 year | 
| Skeletal related events (SRE) | SRE will be defined as: a pathologic fracture, spinal cord compression, necessity for radiation to bone for pain or impending fracture and/or surgery to bone | Up to 1 year | 
| Symptomatic Skeletal Events (SSE) | SSE defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention | Up to 1 year | 
| Time to death |  | Up to 1 year | 
| Sequence of treatment regimens |  | Up to 1 year | 
| Dose schedule |  | Up to 1 year | 
| Duration of therapy |  | Up to 1 year | 
| Time to first visceral metastasis |  | Up to 1 year | 
| Proportion of patients developing visceral metastasis |  | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Bone metastases, Xofigo, Zytiga, Xtandi.