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 SonoVueTM 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.
OBJECTIVE
• To compare prostate cancer (PC) detection rate employing colour Doppler ultrasonography with or without SonoVueTM contrast agent with transrectal ultrasonography‐guided systematic biopsy sampling.
PATIENTS AND METHODS
• 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 SonoVueTM.
• 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.
RESULTS
• 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 SonoVueTM contrast agent were found.
CONCLUSIONS
• Prostate cancer detection rate does not significantly improve with the use of colour Doppler ultrasonography with or without SonoVueTM.
• Although no collateral effects have been highlighted, the combined use of colour Doppler ultrasonography and SonoVueTM determines adjunctive costs and increases the mean time for taking a single prostate biopsy.
In order to evaluate the efficacy of a TSH suppressive dose of levothyroxine to reduce the volume of a single thyroid nodule we studied 55 euthyroid patient: 45 (group A) were suppressed with LT4 (mean 1.7 +/- 0.9 micrograms/Kg/day) for 21.3 +/- 5.3 months, and 10 patients (group B) served as controls. All the nodules were "cold" at scintiscanning, solid at ultrasonography and benign by fine-needle aspiration cytology. As responders were assumed the nodules shrinked at the end of treatment of 50% in volume. Thyroid function values (TSH, T4, FT4, T3, FT3, thyroid peroxidase and thyroglobulin antibodies), clinical and ultrasonographic findings were evaluated initially and at the end of the study. A significant nodular volume decrease occurred in 8 treated patients (17.8%) while 37 (82.2%) amongst the group suppressed and all controls showed no change (A vs B = NS). In two untreated patients new nodules were noted; no new nodules were discovered in the treated group (A vs B p < 005). No side effects occurred in any treated patient, even if at the end of treatment a significant T4 and FT4 (p < 0.01) increase was observed. No one onset parameter can predict the response to the therapy. These results suggest that only a small group of patients affected by a single thyroid nodule seems to respond to a TSH suppressive therapy.
Several phase III clinical trials demonstrated that hepatic arterial chemotherapy for unresectable colorectal liver metastases is able to provide significantly higher response rates than those obtained by systemic route: in more than 500 patients collected from 6 randomized trials, the median values of objective response rates were 55% after fluoxuridine (FUdR) continuous hepatic arterial infusion (HAI) vs. 18.5% after FUdR or 5‐fluorouracil (5‐FU) intravenous (i.v.) chemotherapy. Furthermore, the majority of those studies reported that median survival increased in the patient subgroups treated with intrahepatic chemotherapy, even if not always statistically significant [1‐6]. Certainly, FUdR can be recognized as the first drug, among those regionally given, able to modify the natural history of colorectal liver metastases: it results from both the highest rates of objective responses ever reported in literature and the almost constant notice of unusual sites of extrahepatic metastases [7‐10].
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