The final results of the open phase of the Prostate HistoScanning(TM) European multi-centre clinical study are published. The authors conclude that: "...Prostate HistoScanning(TM) has the potential to benefit the prostate cancer detection and staging pathway with increased cancer detection and tumour localisation...".
WATERLOO (B), 13/12/2011 - Advanced Medical Diagnostics SA/NV (AMD), a privately held company that has developed HistoScanning(TM), today announced the publication of the final results from the open phase of the prospective, multi-centre and pan-European clinical study (PHS-02[i]), evaluating the Prostate HistoScanning(TM) application. HistoScanning(TM) is the award winning Tissue Characterisation modality that utilises raw ultrasound data. HistoScanning(TM) provides additional and meaningful information for better management of cancer patients by providing visual reassurance for decision making.
The publication of the study in the British Journal of Urology International (BJUI)[ii] marks the closure of the "un-blinded" or "open" phase of the study, assessing the relationship between the size and location of lesions detected with Prostate HistoScanning(TM) and those found at histopathology of the prostate gland following its removal by pre-scheduled surgery.
The results establish a strong correlation between the total cancer volume detected in each of the 27 glands by Prostate HistoScanning(TM) and by histopathology.
At the level of individual cancer lesions, Prostate HistoScanning(TM) detected 25 of the 27 foci (91% sensitivity) that were greater than 0.20cc in volume. More detailed analysis by prostate sextant examined the ability of Prostate HistoScanning(TM) not only to detect and size, but also to accurately locate, significant lesions and indicates that Prostate HistoScanning(TM) shows a sensitivity of 90% and a specificity of 72% for the localisation of prostate cancer foci within the 162 sextants (Table 1).
| Table 1: Sextant analysis results for Prostate HistoScanning(TM) at differing volume thresholds | |||
| Volume threshold †' Performance indicator †" | ‰¥0.20cc | ‰¥0.50cc | |
| Sensitivity | 90% | 90% | |
| Specificity | 72% | 70% | |
| Positive predictive value (PPV) | 83% | 84% | |
| Negative predictive value (NPV) | 82% | 80% | |
"We are delighted that the performance of Prostate HistoScanning(TM) has been confirmed in this carefully executed study. In parallel, we have been progressing with the final and "blind" phase of this study. We are pleased to announce that it is in its last stages of recruitment and we look forward to seeing the initial results early in 2012." said Dr. Dror Nir, Managing Director, AMD.
This final, prospective "blind" phase will determine the value of Prostate HistoScanning(TM) in a robust fashion, overcoming many of the biases inherent in evaluating prostate imaging. "This rigorous study design has benefited from the detailed guidance provided by the Principal Investigator, Professor Mark Emberton[iii], and to the appointment of an independent data monitoring committee based in Oxford (UK)," Dr. Nir continued.
This peer reviewed publication follows closely after the reporting of results from seven centres in Germany, the Netherlands and United Kingdom at the annual meeting of the Société Internationale d'Urologie (SIU) in Berlin (D) in October 2011. These independent study reports covered the use of Prostate HistoScanning(TM) in diagnosis, to improve biopsy yield and in surgery planning to reduce the rate of surgical positive margins.
About Advanced Medical Diagnostics SA/NV (AMD)
Advanced Medical Diagnostics SA/NV is a privately held company based in Waterloo, Belgium. The company is dedicated, through its products, to improving cancer patient management in a clinically meaningful and cost effective manner. A dynamic and multinational team of experienced scientists, engineers and business professionals is committed to bringing HistoScanning(TM) to medical specialists and their patients around the world. It is their mission to provide clinically meaningful localisation, quantification and visualisation of differentiated tissues. It is their vision that HistoScanning(TM) will become a standard of care and accessible for all patients around the world.
Press contact
Advanced Medical Diagnostics SA/NV (AMD)
Paula Wittels, Marketing Director
Waterloo Office Park, Dreve Richelle 161, bat i, bte 3
B-1410 Waterloo
T: +32 23 528 030
F: +32 23 528 049
media@histoscanning.com (mailto:media@histoscanning.com)
Bibliography and references
[i] The PHS-02 study is sponsored by AMD.
[ii] SIMMONS (L.A.M.), AUTIER (P.), ZÃT'URA (F.), BRAECKMAN (J.), PELTIER (A.), ROMÃCS (I.), STENZL (A.), TREURNICHT (K.), WALKER (T.), NIR (D.), MOORE (C.M.), EMBERTON (M.). 2011. Detection, localisation and characterisation of prostate cancer by Prostate HistoScanning (http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2011.10734.x/abstract). Published online ahead of printing in British Journal of Urology International (BJUI). 17/11/2011.
[iii] University College London (UCL), Dept. of Surgery and Interventional Sciences, London (UK).
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(ii) they are solely responsible for the content, accuracy and originality of the
information contained therein.
Source: Advanced Medical Diagnostics NV/SA (AMD) via Thomson Reuters ONE
