Clinical trial · Observational
European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Enzalutamide Treatment in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration Resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzalutamide | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients with mCRPC prescribed enzalutamide
- description
- Oral
- interventionNames
- Drug: enzalutamide
Primary outcomes (1)
- measure
- Time to treatment failure (TTF)
- timeFrame
- up to 18 months
- description
- Time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.
Secondary outcomes (17)
- measure
- Time to prostate specific antigen (PSA) progression
- timeFrame
- up to 18 months
- description
- Time from initiation of enzalutamide to the date of PSA progression. PSA progression is defined as a PSA rise of greater than or equal to 25% and an absolute increase of greater than or equal to 2 ng/mL.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Men with mCRPC who have been prescribed enzalutamide as part of standard clinical practice * Germany only: Enzalutamide will be prescribed according to the current SmPC (Summary of Product Characteristics) Exclusion Criteria: * Patients with the following will be excluded from study participation in France only: * Patients who have previously been treated with abiraterone acetate (Zytiga®) after docetaxel chemotherapy. * Patients who have previously been treated with cabazitaxel (Jevtana®) * Patients who have previously been treated with Xtandi® * Patients taking part in an interventional clinical trial
References
Publications (0)
Data not yet available