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Clinical Trials/NCT03328364
NCT03328364CompletedNot Applicable

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

Astellas Pharma a/s1 site in 1 country211 target enrollmentStarted: December 1, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
211
Locations
1
Primary Endpoint
Overall survival in metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide, who have previously undergone treatment with chemotherapy (docetaxel)

Study Overview

Brief Summary

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

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

enzalutamide (mCRPC pre-chemo)

Patients treated with enzalutamide prior to chemotherapy

Intervention: enzalutamide (Drug)

enzalutamide and chemotherapy (mCRPC post chemo)

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

Intervention: enzalutamide (Drug)

enzalutamide and chemotherapy (mCRPC post chemo)

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

Intervention: docetaxel (Drug)

Outcomes

Primary Outcomes

Overall survival in metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide, who have previously undergone treatment with chemotherapy (docetaxel)

Time Frame: Up to a maximum of four years

Overall survival is defined as time from initiation to death of any cause.

Secondary Outcomes

  • Treatment duration of enzalutamide in post chemo mCRPC patients(Up to a maximum of four years)
  • Treatment duration of enzalutamide in pre chemo mCRPC patients(Up to a maximum of four years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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