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

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Astellas

Status

Completed

Conditions

Metastatic Castration Resistant Prostate Cancer

Treatments

Drug: enzalutamide
Drug: docetaxel

Study type

Observational

Funder types

Industry

Identifiers

NCT03328364
9785-MA-3166

Details and patient eligibility

About

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.

Full description

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

Enrollment

211 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

211 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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