OBJECTIVE To assess the extent to which prostate HistoScanningTM (PHS), a new ultrasound‐based technology that uses computer‐aided analysis to quantify tissue disorganization induced by malignant processes, can identify and characterize foci of prostate cancer compared with step‐sectioned radical prostatectomy (RP) specimens. PATIENTS AND METHODS Between September 2004 and February 2006, 29 men had PHS before their scheduled RP. A three‐dimensional ultrasound raw‐data file was acquired, and PHS analysed regions of interest (ROI) corresponding to tissue volumes of ≈ 0.04 mL. In 13 men the histology was examined on sections of the whole‐mount prostate onto which a grid of 5 × 5 mm squares was applied. On a test set of 14 of the 29 patients, PHS analysis was used before knowing the histology results (blinded data), to predict the maximum tumour diameter, focality, laterality and extraprostatic extension (EPE). RESULTS Identification and characterization by PHS of the index tumour in the 14 patients in the test set correlated closely (r = 0.95, P < 0.001) with the reference test. The concordance in the attribution of multifocality (present/absent), unilateral/bilateral disease between PHS and histology was 100%. EPE as determined by PHS was attributed to all three pT3a pathological specimens in the blinded paired data. In the same set of data, EPE was attributed to one prostate cancer that on pathological inspection was deemed to be organ‐confined (pT2b). CONCLUSIONS PHS has the potential to identify and characterize prostate cancer foci noninvasively. The precision appears to be sufficient to suggest that PHS might be useful as a triage test for men deemed to be at risk of prostate cancer and who wish to avoid prostate biopsy.

OBJECTIVE To determine the extent to which computer‐aided ultrasonography of the prostate (HistoScanningTM, Advanced Medical Diagnostics, Waterloo, Belgium) can identify tumour foci that correspond to a volume of ≥0.50 mL. PATIENTS AND METHODS Between September 2004 and February 2006, 29 men were HistoScanned before scheduled radical prostatectomy. The three‐dimensional raw (grey‐scaled) data required for HistoScanning analysis were acquired by transrectal ultrasonography, and analysed using organ‐specific tissue‐characterization algorithms which form the core of the HistoScanning technology. The HistoScanning analysis results were compared with the histology of the whole‐mounted prostate, step‐sectioned sagittally at 5‐mm intervals, and each slide analysed by 5 × 5 mm grid analysis. RESULTS Of 29 patients, 13 had histology unknown to those evaluating the HistoScanning data. With 0.50 mL as the lower threshold for delineating and visualizing cancer volume, HistoScanning correctly predicted the presence of all 12 lesions that were subsequently confirmed to occupy ≥0.50 mL. In addition three lesions were predicted as being present and of ≥0.50 mL. These three lesions were subsequently confirmed to be present but were ≤0.50 mL on histopathological review. Thus, using the clinically accepted volume threshold of 0.50 mL, the sensitivity, specificity, positive and negative predictive value of HistoScanning were 12/12, 13/16 (82%), 12/15 (80%) and 12/12, respectively, for the cancer foci analysed. CONCLUSIONS In this preliminary study, HistoScanning accurately detected cancer foci of ≥0.50 mL; these encouraging results will need to be verified in a larger group of patients.

What ' s known on the subject? and What does the study add?Prostate cancer is one of the few solid-organ cancers in which imaging is not used in the diagnostic process. Novel functional magnetic resonance imaging techniques offer promise but may not be cost-effective.Prostate HistoScanning TM (PHS) is an ultrasound-based tissue characterisation technique that has previously shown encouraging results in the detection of clinically signifi cant prostate cancer. The present study reports on the open ' unblinded ' phase of a European multicentre study. The prospective ' blind ' phase is currently in progress and will determine the value of PHS in a robust fashion overcoming many of the biases inherent in evaluating prostate imaging. OBJECTIVE• To evaluate the ability of prostate HistoScanning TM (PHS) an ultrasound (US)-based tissue characterization application, to detect cancer foci by correlating results with detailed radical prostatectomy (RP) histology. PATIENT AND METHODS• In all, 31 patients with organ-confi ned prostate cancer, diagnosed on transrectal biopsies taken using US guidance, and scheduled for RP were recruited from six European centres.• Before RP three-dimensional (3D) US raw data for PHS analysis was obtained. Histology by Bostwick Laboratories (London) examined sections obtained from whole mounted glands cut every 3 -4 mm.• Location and volume estimation of cancer foci by PHS were undertaken using two methods; a manual method and an embedded software tool.• In this report we evaluate data obtained from a planned open study phase. The second phase of the study is ' blinded ' , and currently in progress. RESULTS• 31 patients were eligible for this phase. Three patients were excluded from analysis due to inadequate scan acquisition and pathology violations of the standard operating procedure. One patient withdrew from the study after 3D TRUS examination.• PHS detected cancer ≥ 0.20 mL in 25/27 prostates (sensitivity 93%).• In all, 23 patients had an index focus ≥ 0.5 mL at pathology, of which 21 were identifi ed as ≥ 0.5 mL by PHS using the manual method (sensitivity 91%) and 19 were correctly identifi ed as ≥ 0.5 mL by the embedded tool (sensitivity 83%).• In 27 patients, histological analysis found 32 cancerous foci ≥ 0.2 mL, located in 97 of 162 sextants. After sextant analysis, PHS showed a 90% sensitivity and 72% specifi city for the localisation of lesions ≥ 0.2 mL within a sextant. CONCLUSIONS• PHS has the ability to identify and locate prostate cancer and consequently may aid in pre-treatment and pre-surgical planning.• In men with a lesion identifi ed, it has potential to enable improved targeting, allowing better risk stratifi cation by obtaining more representative cores.• However further verifi cation from the results of the blinded phase of this study are awaited.

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