Does Prostate HistoScanning™ accurately identify prostate cancer, measure tumour volume and assess pathological stage prior to radical prostatectomy?

Abstract

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.

Does prostate HistoScanning™ play a role in detecting prostate cancer in routine clinical practice? Results from three independent studies

“…The present study reported a sensitivity of 90% and specificity of 72% for lesions ≥0.2 mL, in a selected group. In our third study, we were unable to reproduce these results using the same lesion volume threshold values of ≥0.2 and ≥0.5 mL .…”

“…No correlation was found between the total tumour volume estimated by PHS and histological examination of the whole‐mount prostatectomy specimens (Pearson correlation coefficient = −0.096; Fig. ) . We attempted to account for prostate shrinkage during formalin fixation by weighting the total cancer volume measured on PHS by the ratio of the volume of the prostatectomy specimen to the total prostate volume measured on PHS, but there was no correlation between these corrected PHS cancer volumes and the total tumour volumes on pathology (Pearson correlation coefficient = −0.070).…”

“…Study 3 compared the findings of PHS immediately before surgery with the final whole‐mount radical prostatectomy pathology specimens in 24 patients . The results of each of these studies were disappointing.…”

“…Finally, the detection and localization of extraprostatic extension (EPE) by PHS was compared with the histological evidence of the presence and location of EPE within the whole‐mount prostatectomy specimens. Further details of this study have been published recently .…”

HistoScanningTM to Detect and Characterize Prostate Cancer—a Review of Existing Literature

“…Javed et al performed a prospective analysis in a similar fashion aimed to verify the results of Simmons and Braeckman. [23,24] This study evaluated 24 patients undergoing HS prior to RP. Using only manual tumor evaluation, they reported no correlation between HS tumor volume and HTV, even when correcting for tumor shrinkage.…”