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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

211 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2017-12-24

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.

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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.

Conditions

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Metastatic Castration Resistant Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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enzalutamide (mCRPC pre-chemo)

Patients treated with enzalutamide prior to chemotherapy

enzalutamide

Intervention Type DRUG

oral

enzalutamide and chemotherapy (mCRPC post chemo)

Patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel)

enzalutamide

Intervention Type DRUG

oral

docetaxel

Intervention Type DRUG

intravenous infusion

Interventions

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enzalutamide

oral

Intervention Type DRUG

docetaxel

intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Xtandi MDV3100

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).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No