on-interventional study on the Management of Advanced Prostate Cancer with Triptorelin Pamoate Three Month Formulation (Pamorelin® LA 11.25 mg) or Six Month Formulation (Pamorelin® LA 22.5 mg) with a Focus on Quality of Life, using the PORPUS Questionnaire (Patient-orientated prostate utility scale)
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00003135
- Lead Sponsor
- Ipsen Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 660
Inclusion Criteria
Eligible subjects should fulfill the following:
•Provision of written informed consent
•Male subjects aged 18 years and older with capacity to consent
•Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy or already receiving hormonal deprivation therapy (in this case, the preceding therapy and the reason for change of therapy have to be documented)
•Definition of locally advanced: T3 or T4 or N1 with any T, M0
•Definition of metastatic: any T, any N, M1
Exclusion Criteria
As this is a non-interventional study, no exclusion criteria apply. The investigator has to follow the information in the SmPC, e.g. contraindications, restrictions, precautions.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective(s)<br>To collect data on the quality of life of subjects with advanced<br>prostate cancer treated with triptorelin pamoate 3 month formulation or 6 month formulation and to assess the responder rate at month 6, using the PORPUS questionnaire. (Definition Responder: Improvement of = 5 points in the PORPUS total scale). <br><br>
- Secondary Outcome Measures
Name Time Method