A Registry Based Study Evaluating Overall Survival and Treatment Length in mCRPC Patients Treated With Enzalutamide in Sweden

Study Overview
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Brief Summary
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The purpose of this study is to provide real world data on treatment with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients. The primary purpose is to evaluate overall survival (OS) in mCRPC patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) (post chemo patients). This study will also evaluate treatment duration with enzalutamide in patients pre- and post-chemo.

Detailed Description
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The data source in this study is a local hospital registry created from a patient follow up of prostate cancer patients.

Official Title
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A Registry Based Study Evaluating Overall Survival and Treatment Length in mCRPC Patients Treated With Enzalutamide in Sweden

Conditions
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Metastatic Castration Resistant Prostate Cancer

Intervention / Treatment
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* Drug: enzalutamide
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Chemo naïve mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration). mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration) post chemo. Exclusion Criteria mCRPC patients previously exposed to Radium-223, abiraterone acetate and/or cabazitaxel for mCRPC (pre- and post chemotherapy). Patients previously exposed to chemotherapy or abiraterone acetate+prednisolone in combination with GnRH analogue for hormone sensitive prostate cancer (HSPC).

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 |
| --- | --- |
| enzalutamide (mCRPC pre-chemo)<br>Patients treated with enzalutamide prior to chemotherapy | Drug: enzalutamide<br>* oral<br>* Other names: MDV3100;|
| enzalutamide and chemotherapy (mCRPC post chemo)<br>Patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) | Drug: enzalutamide<br>* oral<br>* Other names: MDV3100;Drug: docetaxel<br>* intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide, who have previously undergone treatment with chemotherapy (docetaxel) | Overall survival is defined as time from initiation to death of any cause. | Up to a maximum of four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration of enzalutamide in pre chemo mCRPC patients | Treatment duration is defined as time from initiation to treatment discontinuation of any cause. | Up to a maximum of four years | 
| Treatment duration of enzalutamide in post chemo mCRPC patients | Treatment duration is defined as time from initiation to treatment discontinuation of any cause. | Up to a maximum of four years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enzalutamide, metastatic castration-resistant prostate cancer, Xtandi, registry based study, MDV3100, mCRPC