ABSTRACT
PURPOSE: To date, few studies have validated the Prostate Imaging Reporting and Data System Version 2 (PI-RADS v. 2) for the diagnosis of prostate cancer. Our aim was to validate PI-RADS v.2 using 3 Tesla (T) MRI. MATERIALS AND METHODS: This is a retrospective study of 54 consecutive patients who underwent 3T MRI with a body-array coil for diagnostic confirmation of prostate cancer or cancer staging between June 2013 and June 2015. Sensitivity, specificity, and agreement were calculated based on a criterion of PI-RADS score = 3. Inter-examiner agreement was determined by the weighted kappa statistic. RESULTS: Histological findings were positive for cancer in 33 patients and negative in 21 patients. Considering a PI-RADS score of 3 as positive for cancer, the accuracy of each reader was 85.20% and 70.40%, respectively, and agreement coefficients were κ = 0.69 and κ = 0.35. Considering PI-RADS 3 as absence of cancer, the accuracy of each reader was 77.80% and 77.80%, respectively, and agreement was κ = 0.55 and κ = 0.54. Inter-reader agreement was moderate/good (weighted κ = 0.53; 95% confidence interval: 0.39-0.66; P = 0.038). CONCLUSION: High accuracy was obtained for the diagnosis of prostate cancer using 3T MRI with a body coil and the PI-RADS v.2 score. J. Magn. Reson. Imaging 2016;44:1354-1359.
Subject(s)
Image Interpretation, Computer-Assisted/standards , Magnetic Resonance Imaging/instrumentation , Magnetic Resonance Imaging/standards , Practice Guidelines as Topic , Prostatic Neoplasms/diagnostic imaging , Radiology Information Systems/standards , Transducers/standards , Aged , Aged, 80 and over , Equipment Design , Humans , Image Interpretation, Computer-Assisted/instrumentation , Internationality , Male , Middle Aged , Prostatic Neoplasms/pathology , Radiation Dosage , Reproducibility of Results , Sensitivity and SpecificityABSTRACT
INTRODUCTION: This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil. AIM: Expanding information on LC efficacy and safety. MAIN OUTCOME MEASURES: International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs). METHODS: A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC. RESULTS: IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] +/- standard deviation [SD]): placebo = 13.9 +/- 5.2 and 14.8 +/- 7.8; LC 40 mg = 13.6 +/- 5.3 and 18.6 +/- 8.0; LC 80 mg = 13.4 +/- 4.9 and 20.6 +/- 7.7 (analysis of variance [ANOVA] P < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M +/- SD): placebo = 55.3 +/- 43.2% and 52.1 +/- 41.4%; LC 40 mg = 46.4 +/- 44.3% and 63.5 +/- 42.0%; LC 80 mg = 50.2 +/- 40.9% and 80.8 +/- 32.3% (ANOVA P < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 +/- 32.3% and 29.7 +/- 38.1%; LC 40 mg = 19.6 +/- 34.3% and 50.8 +/- 44.4%; LC 80 mg = 20.8 +/- 33.2% and 66.0 +/- 39.3% (ANOVA P < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness. CONCLUSIONS: LC showed a satisfactory efficacy-safety profile for oral therapy of ED.
