Diagnostic performance of Prostate HistoScanningTM (PHS) in men at risk of prostate cancer scheduled for an initial prostate biopsy.
Not Applicable
Recruiting
- Conditions
- Subjects suspected to have PCa who are schedules for a first prostate biopsy.C61Malignant neoplasm of prostate
- Registration Number
- DRKS00005263
- Lead Sponsor
- Advanced Medical Diagnostics SAWaterloo Office Park Bât i bte 3
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 391
Inclusion Criteria
•Men at risk of PCa scheduled for first biopsy with serum total PSA
= 20 ng/ml (= 10 ng/mL if taking 5-alpha reductase inhibitors) from maximally 3 months ago
•Signed informed consent
Exclusion Criteria
•Previous prostate biopsy
•Confirmed PCa
•PSA > 20 ng/ml (or > 10 ng/mL if taking 5-alpha reductase inhibitors)
•Active urinary tract infection
•Presence/history of any confirmed cancer
•Recent prostatic surgery (past 6 months)
•History of pelvic radiotherapy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Diagnostic performance of prostate HS to identify clinically significant PCa using prostate biopsy histology from systematic biopsy as reference: receiver operating characteristic (ROC) curve, area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).
- Secondary Outcome Measures
Name Time Method Diagnostic performance of prostate HS to identify PCa using prostate biopsy histology from systematic biopsy as reference: receiver operating characteristic (ROC) curve, area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).<br><br>Diagnostic performance of prostate HS to identify clinically significant PCa using a combination of outcomes of both systematic biopsy and HS guided biopsy histology as reference: receiver operating characteristic (ROC) curve, area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).<br><br>Difference in detection rates of clinically significant PCa between systematic and prostate HS guided biopsy.<br>