on-interventional study to the investigation of the quality of life in patients on Politrate Depot
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00009594
- Lead Sponsor
- ribosepharm division Hikma Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 907
Inclusion Criteria
• male patient
• Signed patient consent form
• Age: = 18 Years
• advanced, hormone-sensitive prostate carcinoma
Exclusion Criteria
• hypersensitivity to the active substances, to any of the excipients or to one of the other ingredients of politrate according to the summary of product characteristics
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Collection on the change of the quality of life using the PORPUS-Questionnaires (Patient ORiented Prostate Utility Scale) during the Lutrate(R)-therapy over the period of therapy in comparison to the baseline.<br>Measurement time: before start of therapy, as part of the first, the second (3 months after enrollment) and the fourth (9 months after enrollment) medication with Lutrate(R) Depot.
- Secondary Outcome Measures
Name Time Method • Collecting safety data<br>• Evaluation of the effectiveness of the treatment according to the course of PSA values and testosterone level (if existing)<br>• Analysis of specifically prostate cancer anamnesis data<br>• evaluation of the efficacy of treatment and of therapy by the physician<br>• determination of adverse drug effects / adverse events;<br><br>The evaluation by the doctor is done one time at the end of the observation as part of the Follow Up. The doctor carries out the overall assessment of therapy in relation to efficacy and compatibility. In this connection he chooses between five possible answers, which are documented in the eCRF (very good, good, medium, rather bad, insufficient).<br>