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

Metastatic Castration Resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328364
• Other study ID #: 9785-MA-3166
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 24, 2017

Study information

• Verified date: August 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: December 24, 2017
• Est. primary completion date: December 24, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Metastatic Castration Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• enzalutamide
oral
• docetaxel
intravenous infusion

Locations

Country	Name	City	State
Sweden	Site SE46001	Malmo

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma a/s

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Link to results on ACSR web site