Evaluation of One-Step Nucleic Acid Amplification (OSNA) for molecular detection of lymph node metastases in patients with prostate cancer
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00011401
- Lead Sponsor
- niversitätsklinik für Urologie, Klinikum Oldenburg, Fakultät für Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 65
Inclusion Criteria
Patients with intermediate or high risk prostate cancer (PSA >10 ng/ml and/or Gleason score =7) scheduled for open radical retropubic prostatectomy with sentinel lymph node dissection and extended lymph node dissection
Exclusion Criteria
Patients unable to consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of sensitivity and specifity of the OSNA assay in detection of lymph node metastases in prostate cancer compared to conventional histopathology and immunohistochemistry
- Secondary Outcome Measures
Name Time Method Determination of concordance rate between the OSNA assay, conventional histopathology and immunohistochemistry concerning the detection of lymph node metatstases as well as the ability to differentiate beween macro- and micrometastases