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

Sponsor

Astellas Pharma a/s (Industry)

Overall Status

Completed

CT.gov ID

NCT03328364

Collaborator

(none)

211

Enrollment

Location

Actual Duration (Days)

279.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Castration Resistant Prostate Cancer	Drug: enzalutamide Drug: docetaxel

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

Actual Enrollment :

211 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2017

Actual Primary Completion Date :

Dec 24, 2017

Actual Study Completion Date :

Dec 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
enzalutamide (mCRPC pre-chemo) Patients treated with enzalutamide prior to chemotherapy	Drug: enzalutamide oral Other Names: Xtandi MDV3100
enzalutamide and chemotherapy (mCRPC post chemo) Patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel)	Drug: enzalutamide oral Other Names: Xtandi MDV3100 Drug: docetaxel intravenous infusion

Arm

Intervention/Treatment

enzalutamide (mCRPC pre-chemo)

Patients treated with enzalutamide prior to chemotherapy

Drug: enzalutamide

oral

Other Names:

Xtandi

MDV3100

enzalutamide and chemotherapy (mCRPC post chemo)

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

Drug: enzalutamide

oral

Other Names:

Xtandi

MDV3100

Drug: docetaxel

intravenous infusion

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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).