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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.
The data source in this study is a local hospital registry created from a patient follow up of prostate cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enzalutamide (mCRPC pre-chemo) | Patients treated with enzalutamide prior to chemotherapy |
| |
| enzalutamide and chemotherapy (mCRPC post chemo) | Patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzalutamide | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Treatment duration of enzalutamide in post chemo mCRPC patients |
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Inclusion criteria:
Exclusion Criteria
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Patients with mCRPC initiating treatment with enzalutamide pre- and post- chemo registered in the prostate cancer registry.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Scientific Advisor | Astellas Pharma a/s | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site SE46001 | Malmö | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31815592 | Derived | 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. |
| Label | URL |
|---|---|
| Link to results on ACSR web site | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| docetaxel | Drug | intravenous infusion |
|
Treatment duration is defined as time from initiation to treatment discontinuation of any cause. |
| Up to a maximum of four years |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |