Multicentre study on the efficacy and tolerability of an extract of Serenoa repens in patients with chronic benign prostate conditions associated with inflammation.

INTRODUCTION: Chronic benign prostate diseases are very common and certainly feature significantly in urological practice.The treatment of chronic benign prostate diseases is a common problem in clinical practice: few studies have been conducted in routine clinical practice to evaluate the efficacy of the treatments for this clinical condition. The objective of this study was to evaluate the efficacy of an extract of Serenoa repens (Permixon) in the treatment of lower urinary tract symptoms (LUTS) in patients with chronic benign prostate diseases with associated inflammation, also taking into consideration the influence of treatment on sexual function and, therefore, on patients' quality of life. MATERIALS AND METHODS: All the 591 eligible subjects were evaluated on entering the study; after a screening visit, including medical history, physical examination, physical examination and digital rectal examination (DRE) and laboratory tests, the patients underwent uroflowmetry. The subjects under investigation were also asked to complete the IPSS, NIH-CPSI and IIEF-5 questionnaires, for the purpose of evaluating urinary symptoms and erectile function in relation to sexual activity in the previous 6 months. RESULTS: The analysis of the uroflowmetry results showed that treatment with extract of Serenoa repens distinctly improves bladder voiding and lower urinary tract symptoms, as highlighted also by the improvement in the scores for the IPSS and NIH-CPSI questionnaires which serve as a basis for evaluating the urinary symptoms of patients with prostatic hyperplasia and chronic prostatitis respectively. The results also suggest that using an extract of Serenoa repens for 6 months in patients with chronic benign prostate diseases gives rise to an improvement in erectile function, as demonstrated by the increase in the scores for the IIEF-5 questionnaire after 6 months of treatment. CONCLUSIONS: The results of this study demonstrate how treatment for 6 months with an extract of Serenoa repens in routine clinical practice gives rise to a statistically significant improvement in Qmax values and in the IPSS, NHI-CPSI and IIEF-5 questionnaire scores, resulting not only in an improvement in urinary symptoms but also in an overall improvement in patients' quality of life.

SelectMDx and Multiparametric Magnetic Resonance Imaging of the Prostate for Men Undergoing Primary Prostate Biopsy: A Prospective Assessment in a Multi-Institutional Study.

Prostate-specific antigen (PSA) testing as the sole indication for prostate biopsy lacks specificity, resulting in overdiagnosis of indolent prostate cancer (PCa) and missing clinically significant PCa (csPCa). SelectMDx is a biomarker-based risk score to assess urinary HOXC6 and DLX1 mRNA expression combined with traditional clinical risk factors. The aim of this prospective multi-institutional study was to evaluate the diagnostic accuracy of SelectMDx and its association with multiparametric magnetic resonance (mpMRI) when predicting PCa in prostate biopsies. Overall, 310 consecutive subjects were included. All patients underwent mpMRI and SelectMDx prior to prostate biopsy. SelectMDx and mpMRI showed sensitivity and specificity of 86.5% vs. 51.9%, and 73.8% vs. 88.3%, respectively, in predicting PCa at biopsy, and 87.1% vs. 61.3%, and 63.7% vs. 83.9%, respectively, in predicting csPCa at biopsy. SelectMDx was revealed to be a good predictor of PCa, while with regards to csPCa detection, it was demonstrated to be less effective, showing results similar to mpMRI. With analysis of strategies assessed to define the best diagnostic strategy to avoid unnecessary biopsy, SelectMDx appeared to be a reliable pathway after an initial negative mpMRI. Thus, biopsy could be proposed for all cases of mpMRI PI-RADS 4-5 score, and to those with Prostate Imaging-Reporting and Data System (PI-RADS) 1-3 score followed by a positive SelectMDx.

PCA3: a new tool to diagnose prostate cancer (PCa) and a guidance in biopsy decisions. Preliminary report of the UrOP study.

OBJECTIVES: PCA3 is a prostate specific non-coding mRNA that is significantly overexpressed in prostate cancer tissue. Urinary PCA3 levels have been associated with prostate cancer grade suggesting a significant role in the diagnosis of prostate cancer. We measured urinary PCA3 score in 925 subjects from several areas of Italy assessing in 114 the association of urinary PCA3 score with the results of prostate biopsy. MATERIAL AND METHODS: First-catch urine samples were collected after digital rectal examination (DRE). PCA3 and PSA mRNA levels were measured using Trascription-mediated PCR amplification. The PCA3 score was calculated as the ratio of PCA3 and PSA mRNA (PCA3 mRNA/PSA mRNA x 1000) and the cut off was set at 35. RESULTS: A total of 925 PCA3 tests were performed from December 2008 to January 2010. The rate of informative PCA3 test was 99%, with 915 subjects showing a valid PCA3 score value: 443 patients (48.42%) presented a PCA3 score >/= 35 (cut-off) whereas the remaining 472 patients (51.58%) presented a PCA3 score lower the cut-off limit (< 35). Of the 443 patients with PCA3 score >/= 35, 105 (23.70%) underwent biopsy or rebiopsy. We found that 27 patients (25.71%) had no tumour at biopsy, 37 (35.24%) had HGPIN or ASAP and 41 (39.05%) had a cancer. Moreover, including the additonal 9 patients with PCA3 < 35, who underwent biopsy post PCA3 results, our data indicate that patients with negative biopsy (n = 31) show lower PCA3 score (mean = 54.9) compared with patients with positive biopsy (n = 45) (mean = 141.6) (p = 0.000183; two-tailed t-student test). The mean PCA3 score (79.6)for the patients diagnosed with HGPIN/ASAP at biopsy (n = 38) was intermediate between patients with negative and positive biopsy. CONCLUSIONS: Our results indicate that the PCA3 score is a valid tool for prostate cancer detection and its role in making better biopsy decisions. This marker consents to discriminate patients who have to undergo biopsy from patients who only need be actively surveilled: Quantitative PCA3 score is correlated with the probability of a positive result at biopsy.