November 30 2011

HistoScanning™: innovative technology establishes itself.
Latest study results on PCa diagnostics presented at the SIU congress 2011 in Berlin.

The latest study data on recently launched HistoScanning™ show positive results not just for detection, staging and therapy planning in the primary diagnosis but also in regard to a rebiopsy in cases of a persistent suspicion of prostate carcinoma (PCa). The data are important steps in further establishing the procedure clinically.

The interest in the study results is huge as the ultrasound based HistoScanning™ seems to be meeting expectations. In addition to positive predictive rates and pre-operative staging of a PCa, the results regarding therapy planning and negative predictive value as well as regarding the procedure’s precision and reliability were also evaluated in the studies presented at the 2011 annual meeting of the Société international d’urologie (SIU).

High detection rate specificity and sensitivity re-confirmed.
Three studies evaluated the detection rates using HistoScanning™ as well as the tumour localisation and tumour volume following radical prostatectomy using histopathological findings.

• The prospective study by Labanaris et al. (n=85) showed a positive predictive PCa rate of 80% vs. the histopathologically based RALP biopsies, with tumour localisation correlating exactly for 77.6% of patients (see Figures 1 and 2). An exact match in determining tumour volume was found in 71.2% of all cases.
• Epplen et al. found a sensitivity of 74% regarding tumour localisation for HistoScanning™ as well as correlation of tumour volume of 55% (n=85). Sensitivity was greater for pT3 (92%) than for pT2 (61.36%). HistoScanning™’s detection rate was 55% for Gleason Score (GS) 6; 74% for GS 7 and 83% for GS ≥ 8. Regarding tumour size, detection rates were 50% for smaller (<1ml), 57.5% for mid-sized (1-5 ml) and 86% for large (>5ml) tumours.
• Preliminary study results from Durner et al. (n=38) see a negative predictive value of 65% for HistoScanning™ (see Table 1). Hence the procedure could be effective for excluding PCa in patients suspected of having prostate carcinoma (PSA increasing and >1 negative biopsy).

All three studies confirm HistoScanning™’s big potential regarding the detection and evaluation of PCa. The authors feel that further studies with a greater number of test subjects are needed to further confirm these initial strong results.

More certainty in pre-operative PCa staging thanks to HistoScanning™.
Leminski et al. show positive results regarding the question of whether refined and optimised staging thanks to Prostate HistoScanning™ can lead to improved operation outcomes. The study group analysed the usability of HistoScanning™ for pre-operative work-up and the planning of erection-protective prostatectomy vs. the usual clinical staging and 3T DW-MRT (n=25 patients, 50 prostate lobes). The nerve-sparing technique was adjusted to 46% as part of the staging using HistoScanning™ compared to established staging and 3T DW-MRT (see table 2). Using HistoScanning™, positive findings of the tumour’s border could be less common, making neuro-protective strategies for prostatectomies safer from an oncological perspective.

Good correlation of histopathology and HistoScanning™ analyses.
Simmons et al. evaluated the accuracy of tumour detection using Prostate HistoScanning™ vs. the commonly used step sectioned procedure. Their findings show that HistoScanning™ provides sufficiently precise results (see Figure 3).

Hence it could be used for therapy planning as well as part of active surveillance.
Hamann et al. compared PCa detection rates for prostate biopsies conducted using HistoScanning™ and systemic transrectal biopsy. The found that it is easy to learn using HistoScanning™ for a biopsy and that the detection rates for both approaches are similar.

To evaluate inter-observer variability in interpreting the images generated by HistoScanning™, van den Heuvel et al. compared the analyses of 198 sextant biopsies as conducted by 2 analysts. Hamann et al. also evaluated the finding of HistoScanning™ guided biopsies regarding inter-observer variability using two histopathologists. Both studies showed little inter-observer variability.

Summary
The presented results regarding the use of HistoScanning™ for detection, staging and therapy planning are highly encouraging. To further validate the procedure for everyday use, additional data from clinical use are needed. There are two larger ongoing studies that were initially presented at 2011 meeting of the Deutsche Gesellschaft für Urologie (DGU) in Hamburg in September 2011: a retrospective study by Heidenreich et al. on "The role of HistoScanning™ in identifying significant prostate carcinoma" and a multicentre health services research study by Durner et al. that has been set up to establish a web-based data registry.


Press release imagery

Figure 1 and 2: Example of the analysis of histopathological state of prostate carcinoma compared to HistoScanning™.				Figure 3: Matching between whole mount histopathology and HistoScanning™ image.

Table 1: Cross-tabular analysis.		Table 2: Planned nerve-sparing approach based on pre-operative MRI standard staging and staging with HistoScanning™ (n=50 lobes).