Department of Urology, Division of Echography, Department of Pathology, Service of Medical Statistics, Laboratories of Quantitative Medicine, IRCCS Istituto Clinico Humanitas, Rozzano, Milan, Italy.
Study Type - Diagnosis (RCT) Level of Evidence 1b.
What's known on the subject? and What does the study add? Transrectal gray-scale ultrasonography guided prostate biopsy sampling is the method for diagnosing prostate cancer (PC) in patients with an increased prostate specific antigen level and/or abnormal digital rectal examination. Several imaging strategies have been proposed to optimize the diagnostic value of biopsy sampling, although at the first biopsy nearly 10-30% of PC still remains undiagnosed. This study compares the PC detection rate when employing Colour Doppler ultransongraphy with or without the injection of SonoVue(TM) microbubble contrast agent, versus the transrectal ultrasongraphy-guided systematic biopsy sampling. The limited accuracy, sensitivity, specificity and the additional cost of using the contrast agent do not justify its routine application in PC detection.
To compare prostate cancer (PC) detection rate employing colour Doppler ultrasonography with or without SonoVue(TM) contrast agent with transrectal ultrasonography-guided systematic biopsy sampling.
A total of 300 patients with negative digital rectal examination and transrectal grey-scale ultrasonography, with PSA values ranging between 2.5 and 9.9 ng/mL, were randomized into three groups: 100 patients (group A) underwent transrectal ultrasonography-guided systematic bioptic sampling; 100 patients (group B) underwent colour Doppler ultrasonography, and 100 patients (group C) underwent colour Doppler ultrasonography before and during the injection of SonoVue(TM) . Contrast-enhanced targeted biopsies were sampled into hypervascularized areas of peripheral, transitional, apical or anterior prostate zones. All the patients included in Groups B and C underwent a further 13 systematic prostate biopsies. The cancer detection rate was calculated for each group.
In 88 (29.3%) patients a histological diagnosis of PC was made, whereas 22 (7.4%) patients were diagnosed with high-grade prostatic intraepithelial neoplasia or atypical small acinar proliferation. No significant differences were found among the three groups for cancer detection rate (P= 0.329). Additionally, low sensitivity, specificity and accuracy of colour Doppler with or without SonoVue(TM) contrast agent were found.
Prostate cancer detection rate does not significantly improve with the use of colour Doppler ultrasonography with or without SonoVue(TM) . Although no collateral effects have been highlighted, the combined use of colour Doppler ultrasonography and SonoVue(TM) determines adjunctive costs and increases the mean time for taking a single prostate biopsy.
Taverna G, Morandi G, Seveso M, Giusti G, Benetti A, Colombo P, Minuti F, Grizzi F, Graziotti P. Are you the author?
Reference: BJU Int. 2011 Jul 14. Epub ahead of print.
UroToday.com Prostate Cancer Section