Observational database serenoa repens (DOSSER): overview, analysis and results. A multicentric SIUrO (Italian Society of Oncological Urology) project.

OBJECTIVE: Men affected with Benign Prostate Hyperplasia (BPH) and Lower Urinary Tract Symptoms (LUTS) are demonstrating to require an increasing amount of attention from Urologists and Primary-care Physicians. Over the years, common urological medications were based on either alpha-blockers and/or 5alpha-reductase inhibitors. During the last decade the phytotherapeutic drugs are gaining a more often central role in the BPH and LUTS managements. In particular, clinical usage of the extract of the dried ripe fruit of serenoa repens with a dosage of 320 mg per day, has shown its clinical efficacy and its superiority. Purpose of this multicentric observational retrospective study was to evaluate all the urological aspects (clinical, biochemical, instrumental and pathological) of patients affected by BPH and LUTS, with a PSA < 10 ng/ml, a previous negative prostatic biopsy and in therapy with a daily dose of 320/640 mg of serenoa repens. PATIENTS AND METHODS: The study was conducted in 8 different centers throughout Italy from September 2010 to November 2011. Data and information of 298 men with an average of 63 years (mean PSA of 5.4 ng/ml and mean prostate gland volume of 57 cc), affected by non-acute urinary symptoms caused by BPH, a dosed PSA level inferior to 10 ng/ml, a previous negative prostate biopsy and in therapy with serenoa repens alone or associated to an alpha-blocker, were retrospectively inserted in an extensive on-line SIUrO Database. Comprehensive questionnaires were filled in for each patient at 3 and 6 months of follow-up. Each questionnaire contained various sections, each of them composed by several items: dosed PSA levels, uroflowmetry, International Prostate Symptoms Score (IPSS), International Index of Erectile Function (IIEF-5), trans-rectal ultrasound (TRUS) patterns, digital rectal examinations (DRE) aspects, previous prostate bioptical results (histology) and side effects. RESULTS: PSA levels weren't subjected to an increase, revealing a stabilizing or downward trend. Percentage of patients with PSA below the level of 4 ng/mL was lower at the end of the study. The overall changes in the uroflowmetry were similar and parallel both in the group with only serenoa repens intake and in the group with serenoa repens plus alpha-blocker. The mean medium flow and the mean maximum flow had a slightly increase along the observation time. There was a substantial decreasing in the amount of patients presenting severe prostatic symptoms. Patients reported through the IIEF-5 score a sexual activity substantially unchanged after 6 months of follow-up. The serenoa repens intake resulted in an improvement of the "inflammatory-like reports", in terms of ultrasound patterns, DRE and bioptical features. CONCLUSIONS: serenoa repens demonstrated its efficacy reducing dysuria with minimal side effects. Further prospective studies might confirm its stabilization or lowering role on PSA levels in this cohort of patients and its possible clinical anti-inflammatory action.

A retrospective study to reduce prostate biopsy cores by a real time interactive tool.

OBJECTIVE: Prostate carcinoma (PCa) is one of the most frequent neoplasms, with more than 110.000 new cases/year in Europe. As PCa is not clearly demonstrable at transrectal ultrasound (TRUS), guidelines on TRUS guided biopsy suggest to perform a random tissue sampling (at least 8-12 "cores" depending on gland volume). Although accuracy grows with core number, patient discomfort and adverse event probability grow as well. Thus it would be worth to aim to reduce the number of prostate biopsy cores without loss of diagnostic accuracy. MATERIALS AND METHODS: A retrospective study was performed to evaluate the feasibility of an improved version of a rtCAB tool developed at DEIS (University of Bologna) for the reduction of prostate biopsy cores. rtCAB is an innovative processing technique which enhances TRUS video stream by a live false color overlay image that helps the physician to perform the biopsy by guiding the sampling into target zones. In order to train rtCAB, a monocentric, single operator prostate gland adenocarcinoma database has been built. The database enlists 81 patients, for a total of 743 prostate byoptic (PBx) cores and 14860 ROI. For each patient we collected age, PSA levels, digital rectal examination (DRE) findings, presence or absence of focal lesions, and prostate volume. During TRUS, raw ultrasound data were acquired and associated to each PBx core. For each core we collected both the radio frequency (RF) signal and the histological outcome. RESULTS: The whole system was optimized for reducing the number of false positives while preserving an acceptable number of false negatives. Comparing to a classical PBx approach (8-12 cores), the estimated positive predictive value (PPV) of our method increased from 25% to 40%, with an overall sensitivity of 85%. CONCLUSIONS: Preliminary results show that the proposed tool can provide real-time feedback to the operator during TRUS. Sensitivity and PPV values suggest that a reduction of almost 50% the number of biopsy cores without losing in diagnostic accuracy is feasible. A prospective study is needed to further confirm these preliminary retrospective results.