ObjectivesTo evaluate the ability of prostate HistoScanning™ (PHS; Advanced Medical Diagnostics, Waterloo, Belgium) to detect, characterize and locally stage prostate cancer, by comparing it with transrectal ultrasonography (TRUS)-guided prostate biopsies, transperineal template prostate biopsies (TTBs) and whole-mount radical prostatectomy specimens. Subjects and MethodsStudy 1. We recruited 24 patients awaiting standard 12-core TRUS-guided biopsies of the prostate to undergo PHS immediately beforehand. We compared PHS with the TRUS-guided biopsy results in terms of their ability to detect cancer within the whole prostate and to localize it to the correct side and to the correct region of the prostate. Lesions that were suspicious on PHS were biopsied separately.Study 2. We recruited 57 patients awaiting TTB to have PHS beforehand. We compared PHS with the TTB pathology results in terms of their ability to detect prostate cancer within the whole gland and to localize it to the correct side and to the correct sextant of the prostate. Study 3. We recruited 24 patients awaiting radical prostatectomy for localized prostate cancer to undergo preoperative PHS. We compared PHS with standardized pathological analysis of the whole-mount prostatectomy specimens in terms of their measurement of total tumour volume within the prostate, tumour volume within prostate sextants and volume of index lesions identified by PHS. ResultsThe PHS-targeted biopsies had an overall cancer detection rate of 38.1%, compared with 62.5% with standard TRUS-guided biopsies. The sensitivity and specificity of PHS for localizing tumour to the correct prostate sextant, compared with standard TRUS-guided biopsies, were 100 and 5.9%, respectively.The PHS-targeted biopsies had an overall cancer detection rate of 13.4% compared with 54.4% for standard TTB. PHS had a sensitivity and specificity for cancer detection in the posterior gland of 100 and 13%, respectively, and for the anterior gland, 6 and 82%, respectively.We found no correlation between total tumour volume estimates from PHS and radical prostatectomy pathology (Pearson correlation coefficient −0.096). Sensitivity and specificity of PHS for detecting tumour foci ≥0.2 mL in volume were 63 and 53%. ConclusionsThese three independent studies in 105 patients suggest that PHS does not reliably identify and characterize prostate cancer in the routine clinical setting.

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Objective: The objective of this paper is to assess the ability of Prostate HistoScanning TM (PHS) to accurately identify tumour volume, index lesion characteristics and pathological stage. PHS is a novel technology employing transrectal ultrasound scanning and software analysis of radiofrequency data to produce signatures for benign and cancerous tissues. Recent reports have suggested PHS is capable of characterising the index cancer lesion and disease multifocality and detecting extraprostatic extension (EPE). Materials and methods:The index test was preoperative PHS on patients undergoing radical prostatectomy (RP). The reference test was the whole-mount pathological analysis of the RP specimen. PHS analysis estimated total tumour volumes, tumour volumes by prostate sextant, the locations and volumes of index lesions, and the presence and location of EPE. Results: There was no correlation between PHS and histology total tumour volume estimates (Pearson coefficient -0.099), despite accounting for specimen fixation shrinkage (Pearson coefficient -0.070), nor among 144 prostate sextants in 24 patients (Pearson coefficient 0.14). Sensitivity and specificity of PHS in detecting foci > 0.2 ml were 63% and 53%, respectively; and 37% and 71%, respectively, for foci > 0.5 ml. Pearson correlation coefficient for index lesion volumes identified at pathology vs PHS was 0.065. PHS failed to locate accurately index lesion and pathological EPE. Conclusions: PHS fails to identify total tumour volumes, tumour volumes prostate sextant, index lesion volumes and locations, and presence and location of EPE compared to RP pathology. PHS appears unsuitable for routine diagnostic clinical use in prostate cancer.

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