on-interventional study for the analysis of efficacy and safety of EstraCept(R) 280 mg (Estramustin phosphate) at patients with castration resistant prostate cancer in three therapy situations
Recruiting
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00003204
- Lead Sponsor
- PharmaCept GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 300
Inclusion Criteria
•Castration resistant prostate cancer
•Advanced status
•Hormone refractory
•Signed patient informed consent
Exclusion Criteria
As described in the product information
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome of this non-interventional study of the therapy of Estramustin phosphate (EMP) is the analysis of an increase of overall survival in the situation of progressive metastatic disease and to which extent a renewed increase of PSA can be delayed.
- Secondary Outcome Measures
Name Time Method •Overall survival of the patients under the different therapy strategies<br>•Impact on the quality of life measured by the PORPUS questionnaire<br>•Detection of adverse drug reactions and adverse events<br><br>