Prostate HistoScanning for the Non-invasive Detection and Staging of Prostate Cancer and Characterization of Prostate Tissues (PHS-02) (PHS-02)
-The study will be a phase I like study to assess the extent to which prostate HistoScanning (PHS, the index test) can identify and characterize foci of prostate cancer when compared to histological samples harvested during radical prostatectomy (the reference test). The study will comprise 3 steps: first, defining the most suitable method for matching the TRUS (TransRectalUltrasonography) to histology (step 1); second, refining the algorithms (training set); third, verification of the PHS performances (test set).
- To evaluate the extent to which PHS can discriminate between malignant lesions of the prostate versus non-malignant tissue in 3D RF TRUS data using radical prostatectomy histological step sectioning as the reference test.
- To adapt and refine PHS tissue characterisation algorithms using RF data that were previously developed using grey-level data as input.
- To assess the accuracy of PHS in predicting the volume of prostate cancers determined by histology.
- To assess the ability of PHS to rule in or rule out the presence of cancer > or = 0.5 cc and of > or = 0.2 cc as determined by histology.
- To evaluate the ability to discriminate primary Gleason pattern 4 and 5 versus 3 or less in tumours > or = 0.5 cc and > or = 0.2 cc.
- To assess the ability of PHS to correctly risk stratify patients.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prostate HistoScanning for the Non-invasive Detection and Staging of Prostate Cancer and Characterization of Prostate Tissues (PHS-02)|
|Study Start Date:||February 2008|
|Study Completion Date:||June 2012|
Patients with histologically proven prostate cancer (positive biopsy) and who are planned to undergo radical prostatectomy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191931
|Brussels, Belgium, 1000|
|Brussels, Belgium, 1090|
|Olomouc, Czech Republic, 775 20|
|Tübingen, Germany, 72076|
|Budapest, Hungary, H-1082|
|Imperial College Healthcare NHS Trust, Charing Cross Hospital|
|Hammersmith, London, United Kingdom, W6 8RF|
|University College London Hospital (UCLH)|
|London, United Kingdom, NW1 2BU|
|Study Director:||Harry Bleiberg, MD|