Metastatic Castration Resistant Prostate Cancer
Conditions
Keywords
enzalutamide, metastatic castration-resistant prostate cancer, Xtandi, registry based study, MDV3100, mCRPC
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.
Interventions
DRUGenzalutamide
oral
DRUGdocetaxel
intravenous infusion
Sponsors
Astellas Pharma a/s
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Sweden
Outcome results
None listed