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

Completed

• Conditions: Metastatic Castration Resistant Prostate Cancer
• Interventions: Drug: enzalutamide; Drug: docetaxel

• Registration Number: NCT03328364
• Lead Sponsor: Astellas Pharma a/s

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 Timeline

• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-01
• Study Start: 2017-12-01
• Primary Completion: 2017-12-24
• Study Completion: 2017-12-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 211

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
enzalutamide (mCRPC pre-chemo)	enzalutamide	Patients treated with enzalutamide prior to chemotherapy
enzalutamide and chemotherapy (mCRPC post chemo)	enzalutamide	Patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel)
enzalutamide and chemotherapy (mCRPC post chemo)	docetaxel	Patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Treatment duration of enzalutamide in post chemo mCRPC patients	Up to a maximum of four years	Treatment duration is defined as time from initiation to treatment discontinuation of any cause.
Treatment duration of enzalutamide in pre chemo mCRPC patients	Up to a maximum of four years	Treatment duration is defined as time from initiation to treatment discontinuation of any cause.

Trial Locations

Locations (1)

Site SE46001; 🇸🇪 Malmo, Sweden