A multi-institutional randomized controlled trial comparing first-generation transrectal high-resolution micro-ultrasound with conventional frequency transrectal ultrasound for prostate biopsy.

Objectives: To study high-frequency 29 MHz transrectal side-fire micro-ultrasound (micro-US) for the detection of clinically significant prostate cancer (csPCa) on prostate biopsy, and validate an image interpretation protocol for micro-US imaging of the prostate. Materials and methods: A prospective randomized clinical trial was performed where 1676 men with indications for prostate biopsy and without known prostate cancer were randomized 1:1 to micro-US vs conventional end-fire ultrasound (conv-US) transrectal-guided prostate biopsy across five sites in North America. The trial was split into two phases, before and after training on a micro-US image interpretation protocol that was developed during the trial using data from the pre-training micro-US arm. Investigators received a standardized training program mid-trial, and the post-training micro-US data were used to examine the training effect. Results: Detection of csPCa (the primary outcome) was no better with the first-generation micro-US system than with conv-US in the overall population (34.6% vs 36.6%, respectively, P = .21). Data from the first portion of the trial were, however, used to develop an image interpretation protocol termed PRI-MUS in order to address the lack of understanding of the appearance of cancer under micro-US. Micro-US sensitivity in the post-training group improved to 60.8% from 24.6% (P < .01), while specificity decreased (from 84.2% to 63.2%). Detection of csPCa in the micro-US arm increased by 7% after training (32% to 39%, P < .03), but training instituted mid-trial did not affect the overall results of the comparison between arms. Conclusion: Micro-US provided no clear benefit over conv-US for the detection of csPCa at biopsy. However, it became evident during the trial that training and increasing experience with this novel technology improved the performance of this first-generation system.

Validation of the omega-3 fatty acid intake measured by a web-based food frequency questionnaire against omega-3 fatty acids in red blood cells in men with prostate cancer.

BACKGROUND/OBJECTIVES: The objective of this study was to evaluate the ability of a web-based self-administered food frequency questionnaire (web-FFQ) to assess the omega-3 (ω-3) fatty acids (FAs) intake of men affected with prostate cancer (PCa) against a biomarker. SUBJECTS/METHODS: The study presented herein is a sub-study from a phase II clinical trial. Enrolled patients afflicted with PCa were included in the sub-study analysis if the FA profiles from the red blood cell (RBC) membranes and FA intakes at baseline were both determined at the time of the data analysis (n=60). Spearman's correlation coefficients were calculated to estimate the correlations between FA intakes and their proportions in the RBC membranes. RESULTS: Intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) were highly correlated with their respective proportions in the RBC membranes (both rs=0.593, P<0.0001). Correlation between alpha-linolenic acid (ALA) intake and its proportion in RBC was not significant (rs=0.130, P=0.332). Correlations were observed between fatty fish intake and total ω-3 FAs (rs=0.304, P=0.02), total long-chain ω-3 FAs (rs=0.290, P=0.03) and DHA (rs=0.328, P=0.01) in RBC membranes. CONCLUSIONS: This study has shown that the web-FFQ is an accurate tool to assess total long-chain ω-3 FAs, EPA and DHA but not ALA intake in clinical trials and epidemiological studies carried out in men with PCa.

Total cholesterol correlates with cyclosporine C2 levels in kidney transplant recipients under maintenance immunosuppression.

The aim of this study was to assess the relationship between cyclosporine (CyA) trough level (C0) and 2-hour postdose (C2) and total cholesterol (TC) in kidney transplant (KT) recipients on Neoral maintenance immunosuppression. In KT recipients who had more than 5 years of follow-up, stable graft function, and stable Neoral dose, we measured C2 and C0 blood levels, serum creatinine, mean total cholesterol (TC) over the last 5 years, prednisone dose, use of beta-blockers and thiazides. Correlations between C0 and C2 levels and TC were performed with the Pearson coefficient. Receiver operating characteristics (ROCs) were used to define the threshold with greater accuracy for significant variables at the correlation test. Statistical tests were performed with SPSS 9.5 The C2 correlated with TC (0.31; P=.008) whereas C0 did not. The C2 level was an independent predictor for TC after adjusting for recipient age, gender, dose of prednisone, creatinine clearance, and use of beta-blockers and thiazides (B coefficient=1.124(E-3); P=.009). A threshold C2 value of 700 microg/L yielded to a TC level of 5.2 mmol/L. This is the first study to report a correlation between C2 levels and TC. Although C2 explained a small fraction of TC variability, it is an independent predictor of TC in KT recipients on Neoral maintenance immunosuppression. A long-term C2 value under 700 microg correlates with better control of hypercholesterolemia.