Clinical trial NCT03328364: A Registry Based Study Evaluating Overall Survival and Treatment Length in mCRPC Patients Treated With Enzalutamide in Sweden
Official title: A Registry Based Study Evaluating Overall Survival and Treatment Length in mCRPC Patients Treated With Enzalutamide in Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration Resistant Prostate Cancer
Keywords: enzalutamide
metastatic castration-resistant prostate cancer
Xtandi
registry based study
MDV3100
mCRPC
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-11-01
Enrollment: 211
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mCRPC initiating treatment with enzalutamide pre- and post- chemo registered in the prostate cancer registry.

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.

Eligibility 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).

Primary outcomes:
measure: Overall survival in metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide, who have previously undergone treatment with chemotherapy (docetaxel)
timeFrame: Up to a maximum of four years
Secondary outcomes:
measure: Treatment duration of enzalutamide in pre chemo mCRPC patients
timeFrame: Up to a maximum of four years
measure: Treatment duration of enzalutamide in post chemo mCRPC patients
timeFrame: Up to a maximum of four years
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Site SE46001
Study officials:
affiliation: Astellas Pharma a/s
name: Medical Scientific Advisor
role: STUDY_CHAIR
References:
citation: Alghazali M, Lofgren A, Jorgensen L, Svensson M, Fagerlund K, Bjartell A. A registry-based study evaluating overall survival and treatment duration in Swedish patients with metastatic castration-resistant prostate cancer treated with enzalutamide. Scand J Urol. 2019 Oct;53(5):312-318. doi: 10.1080/21681805.2019.1657494. Epub 2019 Sep 6.