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Completed

NCT Number: NCT03328364

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

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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Key information

Conditions

Metastatic Castration Resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Site SE46001

Malmö, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Enzalutamide

Drug

oral

Other names: Xtandi, MDV3100

docetaxel

Drug

intravenous infusion

Primary outcomes

  1. 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

  1. Treatment duration of enzalutamide in pre chemo mCRPC patients

    Time frame: Up to a maximum of four years

    Treatment duration is defined as time from initiation to treatment discontinuation of any cause.

  2. Treatment duration of enzalutamide in post chemo mCRPC patients

    Time frame: Up to a maximum of four years

    Treatment duration is defined as time from initiation to treatment discontinuation of any cause.

Sponsors and collaborators

Lead sponsor

Astellas Pharma a/s

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2017
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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