Holmium Laser Enucleation of the Prostate Is Associated with Complications and Sequelae Even in the Hands of an Experienced Surgeon Following Completion of the Learning Curve.

BACKGROUND: Holmium laser enucleation of the prostate (HoLEP) is considered a challenging procedure even for surgeons who have completed the learning curve. OBJECTIVES: To assess outcomes and complications following HoLEP performed by a highly experienced surgeon. DESIGN, SETTING, AND PARTICIPANTS: This was a single-institution prospective study (NCT03583034) performed at a tertiary referral centre that included 243 consecutive patients with lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) treated with HoLEP by a single experienced surgeon (>1600 cases). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patients were assessed using validated questionnaires and uroflowmetry at baseline and several follow-up dates. Intraoperative and postoperative complications were recorded. Kaplan-Meier analysis was used to estimate recovery rates for urinary continence and erectile function. Logistic regression models were constructed to assess predictors of postoperative complications. RESULTS AND LIMITATIONS: Of the 243 patients, 78 (32.1%) had an indwelling urethral catheter. The median prostate volume (PV) was 87 cm3 (interquartile range 60-115) and 146 patients (59.8%) had PV >80 cm3. At 3-mo follow-up, 219 patients (90.1%) had a peak flow rate >20 ml/s and 182 (74.9%) had no postvoid residual urine. The improvement in subjective symptoms was significant at 1-mo follow-up and was maintained until 12 mo after surgery. Urinary continence recovery was slow, with an estimated rate of 68% (95% confidence interval [CI] 62-74%) at 1 mo and 94% (95% CI 91-97%) at 12 mo after HoLEP. The recovery rate for erectile function was 53% (95% CI 46-61%) at 1 mo and 85% (95% CI 77-90%) at 12 mo. Postoperative complications occurred in 36 patients (14.8%) during their hospital stay, in 34 (14%) within 1 mo following discharge from hospital, and in ten (4.1%) at later follow-up dates. Clinically significant complications (Clavien-Dindo ≥2) were observed in 44 cases (18%) and were more common for patients with an indwelling catheter at baseline (odds ratio 5.05; p = 0.006). CONCLUSIONS: HoLEP is an effective procedure for treating LUTS due to BPE, although it is not devoid of complications and sequelae, even in the hands of a highly experienced surgeon. PATIENT SUMMARY: Holmium laser treatment of the prostate to reduce its size has positive results for urinary function when performed by an experienced surgeon, even in complex cases, although there can be complications.

Impact of Early Dorsal Venous Complex Ligation on Urinary Continence Recovery after Robot-assisted Radical Prostatectomy: Results from a Phase 3 Randomized Controlled Trial.

BACKGROUND: Whether early ligation of the dorsal venous complex (DVC) might improve recovery of urinary continence (UC) after robot-assisted radical prostatectomy (RARP) has never been investigated in a prospective randomized study. OBJECTIVE: To assess whether early DVC ligation might affect UC recovery after RARP. INTERVENTION: DVC ligation (early vs standard). DESIGN, SETTING, AND PARTICIPANTS: A total of 312 patients with prostate cancer underwent primary RARP at a tertiary care institution. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was UC recovery at 1 and 4 mo after RARP. UC was defined as 0 pads/1 safety pad per day. All patients completed the International Prostate Symptom Score (IPSS) and International Consultation of Incontinence Questionnaire (ICIQ)-Short Form questionnaires. Secondary outcomes were early (≤4 mo) erectile function recovery, the positive surgical margin (PSM) rate, 30-d Clavien-Dindo complications, and biochemical recurrence rates. Quality of life was assessed using the EQ-5D-5L questionnaire. The association between treatment arm and UC recovery was also tested using multivariable regression models. RESULTS AND LIMITATIONS: After surgery, 23 patients withdrew their consent and 29 were lost to follow-up, leaving 261 patients available for per-protocol analyses. Of these, 32 patients (24%) in the experimental group and 37 (29%) in the control group used no pad/one safety pad at 1 mo after RARP, whereas 96 (72%) in the control group versus 83 (65%) in the control group were continent at 4-mo follow-up (both p = 0.3). Median ICIQ and IPSS scores did not differ between the groups at both time points. The results were confirmed on multivariable regression analyses. PSMs were observed for 32 patients (25%) in the experimental group versus 30 (22%) in the control group (p = 0.6). The incidence of postoperative complications (17% experimental vs 13% control) and the 1-yr biochemical recurrence-free survival did not differ between the groups. CONCLUSIONS: In this randomized clinical trial, we did not find evidence that early ligation of the DVC during RARP was associated with better UC recovery after surgery in comparison to the standard technique. Given its safety in terms of surgical margins and complications, this technique may be considered as an option for surgical dissection according to the physician's preference. PATIENT SUMMARY: Our trial showed that for patients undergoing robot-assisted surgical removal of the prostate, the timing of a specific step to control bleeding from a network of veins draining the prostate did not affect recovery of urinary continence after surgery. The results indicate that earlier control of these veins may be considered as an option according to the surgeon's preference.

Rates and predictors of postoperative complications after Holmium laser enucleation of the prostate (HoLEP) at a high-volume center.

BACKGROUND: Holmium laser enucleation of the prostate (HoLEP) is considered a challenging procedure with a non-negligible risk of complications limiting its widespread adoption. We investigated rates and preoperative predictors of complications in a high-volume center with long-time experience. METHODS: Data from 284 patients treated with HoLEP between 2015 and 2017 were analyzed. Postoperative complications occurring up to 12 months after surgery were collected following the EAU guidelines recommendations. Procedure-specific complications were defined and graded by using the Clavien-Dindo (CD) system. Logistic regression analysis evaluated preoperative risk factors for postoperative complications. RESULTS: Baseline prostate volume was (median, IQR) 87 (60, 120) ml. As a whole, in-hospital and after discharge complications were 19% and 11.6%, respectively, with a 28.6% overall rate at 12 months from surgery. Complications were graded as CD 1 (8% [22]), 2 (18.2% [52]) and 3 (1.8% [5]), respectively. Fever was the most frequently reported (11% of cases), followed by acute urinary retention (8%). At logistic regression analysis, older age (OR: 1.07; 95%CI: 1.01-1.12; P=0.01) and having an indwelling catheter before surgery (OR: 4.03; 95%CI 1.64-9.9; P=0.002) emerged as significant risk factors for post-HoLEP complications, after accounting for surgeon experience and baseline parameters. CONCLUSIONS: HoLEP is a safe procedure in a high-volume center with less than 2% high-grade complications. Older patients with indwelling catheter deserve to be carefully managed due to a higher risk of postoperative complications.

Ten-year Follow-up Results After Holmium Laser Enucleation of the Prostate.

BACKGROUND: Scarce data are available about long-term follow-up (FU) in men undergoing holmium laser enucleation of the prostate (HoLEP). OBJECTIVE: To investigate the risk of being symptomatic at 10-yr FU after HoLEP. DESIGN, SETTING, AND PARTICIPANTS: Perioperative data from 125 patients submitted to HoLEP in 2007-2010 by a single, highly experienced surgeon were analyzed. Patients were assessed by International Prostate Symptoms Score (IPSS), prostate-specific antigen (PSA), and uroflowmetry at 6-mo and 10-yr FU. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Logistic regression models tested the association between clinically significant predictors and the risk of being symptomatic at long-term FU (defined as IPSS≥8 and/or peak flow rate [PFR]<15ml/s and/or postvoid residual volume [PVR]>20ml, need for symptomatic medical treatment, or redo surgery). RESULTS AND LIMITATIONS: At surgery, median (interquartile range) age was 66 years (61, 69), prostate volume was 78ml (56, 105), and PFR was 9ml/s (7, 12). All patients showed favorable outcomes (ie, IPSS and uroflowmetry parameters) 6 months after surgery. At median 126-month FU, PFR was 16ml/s (13, 23), PVR was 10ml (5, 15), total IPSS was 5 (1-7), and PSA was 0.7 ng/ml (0.4, 1.3). Of all, 32 patients (26%) were symptomatic at long-term FU, seven (5.7%) reported urinary incontinence, and six (4.7%) underwent redo surgery throughout the FU period due to either bladder neck contracture or urethral stricture. Older patients at surgery (odds ratio [OR]: 1.12; 95% confidence interval [CI]: 1.03-1.22; p=0.006) and patients who never recovered full continence postoperatively (OR: 0.49; 95% CI: 0.01-0.27; p=0.001) were at a higher risk of being symptomatic at very long-term FU, after adjusting for baseline clinical characteristics. CONCLUSIONS: HoLEP ensures a durable relief of urinary symptoms in almost 75% of patients up to 10 years after surgery. Older patients and those who do not recover from incontinence after surgery should be counseled carefully regarding a higher risk of symptom recurrence at long-term assessment. PATIENT SUMMARY: Consistent symptom relief is preserved even 10 years after holmium laser enucleation of the prostate in almost 75% of patients. Older age and incomplete continence recovery after surgery were the two most relevant risk factors for being symptomatic at long-term follow-up. Postoperative functional outcomes are kept in three out of four patients at 10-yr follow-up after holmium laser enucleation of the prostate. Conversely, the older the patient at surgery and the presence of incomplete continence recovery throughout the postoperative period, the greater the probability of being symptomatic at long-term follow-up.

Clinical Comparison of Holmium Laser Enucleation of the Prostate and Bipolar Transurethral Enucleation of the Prostate in Patients Under Either Anticoagulation or Antiplatelet Therapy.

BACKGROUND: A significant number of patients who require surgery for benign prostatic hyperplasia are under either anticoagulation (AC) or antiplatelet (AP) therapy. OBJECTIVE: To assess the efficacy and morbidity of holmium laser enucleation of the prostate (HoLEP) and bipolar transurethral enucleation of the prostate (B-TUEP) in patients who required AC/AP therapy. DESIGN, SETTING, AND PARTICIPANTS: This study included 296 (67.6%) and 142 (32.4%) patients who underwent HoLEP and B-TUEP, respectively. The AC/AP group included patients whose AP therapy was not interrupted pre-, peri-, and/or postoperatively, and patients who underwent perioperative AC therapy bridging with low-molecular-weight heparin. INTERVENTION: HoLEP and B-TUEP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We tested the hypothesis that AC/AP therapy had a limited impact on the efficacy of HoLEP and B-TUEP. To adjust for potential baseline confounders, propensity-score matching was performed. Clinical characteristics were compared among groups using the Kruskal-Wallis or chi-square test. Logistic regression analyses tested the association between clinical variables and the odds of Clavien-Dindo ≥2 complications after surgery. RESULTS AND LIMITATIONS: Overall, 28 (9.5%) and 46 (15.5%) patients in the HoLEP group and 15 (10.5%) and 24 (16.9%) men in the B-TUEP group had AC and AP therapy, respectively (p=0.9). HoLEP patients under either AC or AP therapy deserved longer catheter maintenance and a longer hospital stay (HS) than those without AC/AP therapy (all p≤0.01). Operative time, rates of postoperative complications, and 2-mo International Prostate Symptoms Score (IPSS) were similar between patients with and without AC/CP. Among B-TUEP patients, HS was longer (p=0.03) and the rate of complications was higher (p<0.001) in patients under AC or AP therapy. Postoperative haemoglobin drop and 2-mo IPSS were similar among groups and surgical techniques. Limitations are the retrospective nature of the study, and the lack of long-term complications and functional outcomes. CONCLUSIONS: HoLEP and B-TUEP can safely be performed in patients deserving continuous AP/AC therapy with only a slight increase in HS and catheterisation time. PATIENT SUMMARY: We assessed the safety and efficacy of holmium laser enucleation of the prostate (HoLEP) and bipolar transurethral enucleation of the prostate (B-TUEP) in men under chronic anticoagulation/antiplatelet therapy. Both HoLEP and B-TUEP could safely be performed as minimally invasive treatment options in this subset of patients at a high risk of bleeding from benign prostatic hyperplasia surgery.

Not All Multiparametric Magnetic Resonance Imaging-targeted Biopsies Are Equal: The Impact of the Type of Approach and Operator Expertise on the Detection of Clinically Significant Prostate Cancer.

BACKGROUND: The extensive use of multiparametric magnetic resonance imaging (mpMRI) has led to an even more widespread use of different targeted biopsy techniques and approaches. The best way of performing targeted biopsies and the effect of operator expertise have still to be defined. OBJECTIVE: To compare the rate of detection of clinically significant prostate cancer (csPCa) of different mpMRI targeted approaches and to assess the role of operator expertise in the detection of csPCa. DESIGN, SETTING, AND PARTICIPANTS: We included 244 consecutive patients who underwent both 12-core transrectal ultrasound (TRUS) biopsy and mpMRI targeted biopsy with either a cognitive biopsy (CB) or fusion biopsy (FB) approach during the same session between 2013 and 2016 at a single tertiary referral centre. INTERVENTION: All men underwent 1.5-T mpMRI with an endorectal coil. All biopsies were performed by three operators as their first cases of targeted biopsy. Lesions with a Prostate Imaging Recording and Data System (PI-RADS) v.2 score of ≥3 detected at mpMRI were targeted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: csPCa was defined as disease with a Gleason score at biopsy of ≥7. Operator expertise was coded as the progressive number of targeted biopsies performed by each physician. Multivariable logistic regression analyses (MVA) were used to assess the association between the targeted biopsy technique (FB vs CB) and operator expertise for detection of csPCa. Covariates consisted of prostate-specific antigen, prostate volume, PI-RADS v.2 (3 vs >3), number of targeted cores per MRI lesion, and digital rectal examination (negative vs positive). The same analyses were performed for patients undergoing FB only after accounting for the FB approach (transrectal vs transperineal). A lowess smoothing weighted function was used to graphically assess the effect of operator expertise on the probability of detecting csPCa, after accounting for all confounders. RESULTS AND LIMITATIONS: Overall, 157 patients (64%) underwent FB and 87 (36%) underwent CB. The overall csPCa detection rate was 58% for FB and 45% for CB (p=0.07). A significantly higher rate of csPCa detection in targeted samples was observed for FB compared to CB (57% vs 36%; p=0.002). On MVA, FB and operator expertise were significantly associated with a higher probability of csPCa detection in targeted samples (odds ratio [OR] 2.4 and 1.7, respectively; both p≤0.03). When the same analyses were repeated for patients undergoing FB, operator expertise remained an independent predictor of csPCa detection (OR 1.9; p=0.004). An increase in the probability of detecting csPCa with the number of procedures performed was observed after accounting for all confounders. CONCLUSIONS: We demonstrated that FB had higher detection rate than CB for csPCa. Moreover, operator expertise was significantly associated with higher detection rates for csPCa. PATIENT SUMMARY: When different targeted biopsy techniques were compared, fusion biopsy provided a higher detection rate compared to cognitive biopsy for clinically significant prostate cancer (csPCa). Moreover, we found that operator expertise was an important predictor of the detection of csPCa, regardless of the procedure used.

Italian Prostate Biopsies Group: 2016 Updated Guidelines Insights.

AIM: To present a summary of the updated guidelines of the Italian Prostate Biopsies Group following the best recent evidence of the literature. MATERIALS AND METHODS: A systematic review of the new data emerging from 2012-2015 was performed by a panel of 14 selected Italian experts in urology, pathology and radiology. The experts collected articles published in the English-language literature by performing a search using Medline, EMBASE and the Cochrane Library database. The articles were evaluated using a systematic weighting and grading of the level of the evidence according to the Grading of Recommendations Assessment, Development and Evaluation framework system. RESULTS: An initial prostate biopsy is strongly recommended when i) prostate specific antigen (PSA) >10 ng/ml, ii) digital rectal examination is abnormal, iii) multiparametric magnetic resonance imaging (mpMRI) has a Prostate Imaging Reporting and Data System (PIRADS) ≥4, even if it is not recommended. The use of mpMRI is strongly recommended only in patients with previous negative biopsy. At least 12 cores should be taken in each patient plus targeted (fusion or cognitive) biopsies of suspicious area (at mpMRI or transrectal ultrasound). Saturation biopsies are optional in all settings. The optimal strategy for reducing infection complications is still a controversial topic and the instruments to reduce them are actually weak. The adoption of Gleason grade groups in adjunction to the Gleason score when reporting prostate biopsy results is advisable. CONCLUSION: These updated guidelines and recommendations are intended to assist physicians and patients in the decision-making regarding when and how to perform a prostatic biopsy.

Apparent diffusion coefficient in the evaluation of side-specific extracapsular extension in prostate cancer: Development and external validation of a nomogram of clinical use.

OBJECTIVES: The aim of this study is to develop a nomogram of clinical utility based on apparent diffusion coefficient (ADC) from diffusion-weighted imaging to predict extracapsular extension (ECE), and to validate externally its clinical utility. MATERIALS AND METHODS: A total of 101 men (70 for the creation and 31 for external validation of the nomogram) underwent 1.5T multiparametric magnetic resonance imaging followed by radical prostatectomy at 2 different institutions. ADC values were assessed for normal and pathological tissue. Clinical and pathological variables were investigated by univariate and multivariate logistic regression analyses on 70 patients and logistic regression coefficients were used to develop our nomogram. Receiver operating characteristic curve analysis was performed to determine the optimal ADC cut off for ECE. The nomogram was then externally validated on 31 patients at another institution. RESULTS: At univariate analysis, the following variables were associated with ECE: pathological ADC and Gleason at biopsy (P<0.001) along with tumor volume and ECE at imaging (P = 0.003). At multivariate analysis, pathological ADC (P = 0.027), tumor volume (P = 0.011), and biopsy Gleason (P = 0.040) maintained their independent predictor status and were included in our nomogram together with normal ADC and ECE at imaging. Our nomogram showed a significant higher sensitivity (88%) than T2-weighted imaging (54%; P = 0.010). External validation resulted in an overall accuracy of 81%. CONCLUSIONS: ADC represents a potential imaging biomarker to predict side-specific ECE in patients with prostate cancer. Our nomogram could improve the current diagnostic pathway and possibly the therapeutic approach for this disease.

Evaluating serum insulin-like growth factor 1 and insulin-like growth factor binding protein 3 as markers in prostate cancer diagnosis.

BACKGROUND: Prostate-specific antigen (PSA) lacks specificity and sensitivity in discriminating prostate cancer (PCa) from benign prostatic hyperplasia (BPH) when the total PSA (tPSA) level is between 4 and 10 ng/mL. It remains to be investigated if additional tumor-associated molecules may improve the PCa diagnostic accuracy. The aim of the present study was to investigate whether serum levels of insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein 3 (IGFBP3) and their combinations with PSA may enhance the diagnosis of PCa. METHODS: Serum tPSA and free PSA (fPSA) levels were measured using an automated chemiluminescence-based method. IGF1 and IGFBP3 levels were evaluated by radioimmunoassays in a prospectively and consecutively enrolled subset of 149 patients with tPSA ≤10 ng/mL made up of patients with benign prostatic hyperplasia (BPH; n = 113) and PCa (n = 36). RESULTS: IGF1 and IGFBP3 serum levels did not significantly differ between the PCa and BPH groups. No important correlation was found between the IGF molecules and PSA isoforms in both groups. Statistical analysis of the combination of markers indicated that only the free/total PSA ratio (f/tPSA%) was informative and independent in predicting the presence of PCa, considering that for high values of this percentage (17%) the probability of finding PCa decreased. Receiver operating characteristics areas under the curve (AUC) for IGF1 and IGFBP3 were not informative (AUC ~0.5 in both cases) contrary to the AUC for f/tPSA% (AUC = 0.689, p = 0.0002). CONCLUSIONS: The present study showed that neither IGF1 and IGFBP3 alone nor in combination with PSA enhance the diagnostic performance of PSA in PCa.

Long-term outcomes of salvage lymph node dissection for clinically recurrent prostate cancer: results of a single-institution series with a minimum follow-up of 5 years.

BACKGROUND: Prostate cancer (PCa) patients with lymph node recurrence after radical prostatectomy (RP) are usually managed with androgen-deprivation therapy. Despite the absence of prospective randomized studies, salvage lymph node dissection (LND) has been proposed as an alternative treatment option. OBJECTIVE: To examine long-term outcomes of salvage LND in patients with nodal recurrent PCa documented by 11C-choline positron emission tomography/computed tomography (PET/CT) scan. DESIGN, SETTING, AND PARTICIPANTS: Overall, 59 patients affected by biochemical recurrence (BCR) with 11C-choline PET/CT scan with pathologic activity treated between 2002 and 2008 were included. INTERVENTION: Pelvic and/or retroperitoneal salvage LND. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: Biochemical response (BR) was defined as prostate-specific antigen (PSA) <0.2 ng/ml at 40 d after surgery. BCR for those who achieved BR was defined as a PSA >0.2 ng/ml. Clinical recurrence (CR) was defined as a positive PET/CT scan after salvage LND in the presence of a rising PSA. Kaplan-Meier curves assessed time to BCR, CR, and cancer-specific mortality (CSM). Cox regression analyses were fitted to assess predictors of CR. RESULTS AND LIMITATIONS: Median follow-up after salvage LND was 81.1 mo. Overall, 35 patients (59.3%) achieved BR. The 8-yr BCR-free survival rate in patients with complete BR was 23%. Overall, the 8-yr CR- and CSM-free survival rates were 38% and 81%, respectively. In multivariable analyses evaluating preoperative variables, PSA at salvage LND represented the only predictor of CR (p=0.03). When postoperative variables were considered, BR and the presence of retroperitoneal lymph node metastases were significantly associated with the risk of CR (all p ≤ 0.04). Our study is limited by the lack of a control group. CONCLUSIONS: Salvage LND may represent a therapeutic option for patients with BCR after RP and nodal pathologic uptake at 11C-choline PET/CT scan. Although most patients progressed to BCR after salvage LND, roughly 40% of them experienced CR-free survival. PATIENT SUMMARY: Salvage lymph node dissection may represent a therapeutic option for selected patients with nodal recurrence after radical prostatectomy. Roughly 40% of men did not show any further clinical recurrence at long-term follow-up after surgery.

Approaches for Initial Prostate Biopsy and Antibiotic Prophylaxis.

CONTEXT: Debate on the optimal technique to use as an initial prostate biopsy (PB) strategy is continually evolving. OBJECTIVE: To review recent advances and current recommendations regarding initial PB and antibiotic prophylaxis. EVIDENCE ACQUISITION: A nonsystematic review of the literature was performed up to October 2014 using the PubMed and Embase databases. Articles were selected with preference for the highest level of evidence in publications within the past 5 yr. EVIDENCE SYNTHESIS: The decision to perform PB is still based on an abnormal digital rectal examination or increased prostate0specific antigen (PSA) level without clear consensus about the absolute cutoff. Several biomarkers have been suggested to improve PSA-based PB decision-making and minimize overdiagnosis and overtreatment. The random 12-core transrectal (TR) ultrasound-guided approach remains the standard-of-care technique for PB. A >12-core scheme may be considered as an alternative in a single patient given his clinical features (large volume, low PSA levels). Transperineal biopsies may only be considered as an alternative to the TR route in special situations. Nevertheless, given the increase in antimicrobial resistance, the impact on the post-biopsy sepsis rate should be assessed in well-designed clinical trials. Imaging-guided targeted PB strategies, combined or not with random PBs, may represent the future of prostate cancer diagnosis by reducing the number of PBs and improving decision-making. CONCLUSIONS: The 12-core TR scheme remains the standard of care for initial PB. The actual trend for PB strategy, with the aim of avoiding overdiagnosis of very low-risk cancers, could rapidly change our current indications and techniques through new biomarkers and imaging-guided targeted strategies. Nevertheless, the cost-benefit balance of these techniques should be closely assessed in the setting of initial PB strategy. PATIENT SUMMARY: This review highlights current recommendations for prostate biopsy and possible advances in the near future.

The number of cores at first biopsy may suggest the need for a confirmatory biopsy in patients eligible for active surveillance-implication for clinical decision making in the real-life setting.

OBJECTIVE: To assess whether the number of cores at first prostate biopsy affect pathologic findings at radical prostatectomy (RP) in potential candidates for active surveillance (AS). MATERIAL AND METHODS: Two hundred seventy-five patients fulfilling Prostate Cancer Research International: Active Surveillance criteria (prostate-specific antigen level ≤ 10 ng/mL, prostate-specific antigen density <0.2 ng/mL/cm(3), number of positive cores ≤ 2, T1c-T2 clinical stage, Gleason score [GS] ≤ 6) underwent RP between 2005 and 2013 at a single institution. Patients were stratified into 3 groups according to different biopsy schemes (≤ 12 vs 13-18 vs ≥ 19 cores). Rates of pathologically confirmed insignificant prostate cancer (pIPCa; defined as RP GS ≤ 6, tumor volume ≤ 0.5 mL, and organ-confined disease) and unfavorable disease (UD, defined as non-organ-confined disease and/or pathologic GS ≥ 7) at RP were stratified according to the biopsy schemes. Logistic regression analyses tested the effect of preoperative variables in predicting pIPCa and UD at RP. RESULTS: Of all, 23.3% and 33.4% patients harbored pIPCa and UD, respectively. pIPCa and UD were found in 15.7%, 32.1%, 25.3% (P = .04) and in 48.1%, 23.8%, 24.1% (P <.001) patients with ≤ 12, 13-18, ≥ 19 cores, respectively. At multivariate analyses, number of biopsy cores emerged as an independent predictor of both pIPCa (≤ 12 vs 13-18 cores: odds ratio [OR] = 2.34; P = .02) and UD (≤ 12 vs 13-18 cores: OR = 0.39; P <.01; ≤ 12 vs ≥ 19 cores: OR = 0.38; P <.01). CONCLUSION: Among candidates for AS, number of biopsy cores emerged as an independent predictor of pIPCa and UD at RP. These findings would suggest that the extent of initial biopsy sampling should be considered when addressing patients to AS and before planning any surveillance strategies.

Random biopsy: when, how many and where to take the cores?

PURPOSE: The optimal random prostate biopsy scheme (PBx) in the initial and repeated setting is still an issue of controversy. We performed an analysis of the recent literature about the prostate biopsy techniques. METHODS: We performed a clinical and critical literature review by searching MEDLINE database from January 2005 up to January 2014. Electronic searches were limited to the English language, and the keywords prostate cancer, prostate biopsy, transrectal ultrasound, transperineal prostate biopsy were used. RESULTS: Prostate biopsy strategy in initial setting. According to the literature and the major international guidelines, the recommended approach in initial setting is still the extended scheme (EPBx) (12 cores). However, there is now a growing evidence in the literature that (a) saturation PBx (>20 cores) (SPBx) might be indicated in patients with PSA <10 ng/ml or low PSA density or large prostate and (b) an individualized approach with more than 12 cores according to the clinical characteristics of the patients may optimize cancer detection in the single patient. Moreover, in the era of multi-parametric MRI (mpMRI), EPBx or SPBX may be substituted by mpMRI-targeted biopsies that have demonstrated superiority over systematic random biopsies for the detection of clinically significant disease and representation of disease burden, while deploying fewer cores. Prostate biopsy strategy in repeat setting. How and how many cores should be taken in the different scenarios in the repeated setting is still unclear. SPBx clearly improves cancer detection if clinical suspicion persists after previous biopsy with negative findings and is able to provide an accurate prediction of prostate tumour volume and grade. Nevertheless, international guidelines do not strongly recommended SPBx in all situations of repeated setting. In the active surveillance and in focal therapy protocols, the optimal schemes have to be defined. CONCLUSIONS: The course of PBx has changed significantly from sextant biopsies to systematic and from extended to SPBx schemes. The issue about the number and location of the cores is still a matter of debate both in initial and in repeat setting. At present, EPBx is sufficient in most of the cases to provide adequate diagnosis and prostate cancer characterization in the initial setting, while SPBx seems to be necessary in repeat setting. The PBx schemes are evolving also because the scenario in which a PBx is necessary is changing. Random prostate PBx do not represent the future, while imaging target biopsy are becoming more popular.

Practical recommendations for performing ultrasound scanning in the urological and andrological fields.

AIM: US scanning has been defined as the urologist's stethoscope. These recommendations have been drawn up with the aim of ensuring minimum standards of excellence for ultrasound imaging in urological and andrological practice. A series of essential recommendations are made, to be followed during ultrasound investigations in kidney, prostate, bladder, scrotal and penile diseases. METHODS: Members of the Imaging Working Group of the Italian Society of Urology (SIU) in collaboration with the Italian Society of Ultrasound in Urology, Andrology and Nephrology (SIEUN) identified expert Urologists, Andrologists, Nephrologists and Radiologists. The recommendations are based on review of the literature, previously published recommendations, books and the opinions of the experts. The final document was reviewed by national experts, including members of the Italian Society of Radiology. RESULTS: Recommendations are listed in 5 chapters, focused on: kidney, bladder, prostate and seminal vesicles, scrotum and testis, penis, including penile echo-doppler. In each chapter clear definitions are made of: indications, technological standards of the devices, the method of performance of the investigation. The findings to be reported are described and discussed, and examples of final reports for each organ are included. In the tables, the ultrasound features of the principal male uro-genital diseases are summarized. Diagnostic accuracy and second level investigations are considered. CONCLUSIONS: Ultrasound is an integral part of the diagnosis and follow-up of diseases of the urinary system and male genitals in patients of all ages, in both the hospital and outpatient setting. These recommendations are dedicated to enhancing communication and evidence-based medicine in an inter- and multi-disciplinary approach. The ability to perform and interpret ultrasound imaging correctly has become an integral part of clinical practice in uro-andrology, but intra and inter-observer variability is a well known limitation. These recommendations will help to improve reliability and reproducibility in uro-andrological ultrasound scanning.

Repeated biopsy in the detection of prostate cancer: when and how many cores.

PURPOSE: We performed an analysis of the literature about the optimal prostate biopsy (PBX) scheme in the repeated setting METHODS: We performed a clinical and critical literature review by searching Medline Database from January 2005 up to January 2014. Electronic searches were limited to the English language. The keywords were: prostate cancer, prostate biopsy, transrectal ultrasound, transperineal prostate biopsy. RESULTS: The recommended approach in repeated setting is still the extended scheme (EPBx) (12 cores). An approach with more than 12 cores according to the clinical characteristics of the patients may optimize cancer detection. Saturation PBx (> 20 cores) clearly improves cancer detection if clinical suspicion persists after previous negative biopsy. Nevertheless international guidelines do not strongly recommended SPBx in all situations of repeated setting. EPBx or SPBX may be, in the future, substituted by multiparametric MRI-targeted biopsies. CONCLUSIONS: Since the scenario in which a PBx is changing, the issue about the number and location of the cores in PBx is still a matter of debate in repeated setting. At present, EPBx are still the gold standard even if SPBx seems to be necessary in many cases. However, random PBx does not represent the approach of the future, but rather imaging targeted biopsy.

Prostate cancer detection rates in different biopsy schemes. Which cores for which patients?

PURPOSE: To determine whether the addition of four paramedian peripheral and four lateral peripheral cores improves the cancer detection rate (CDR) of the extended 10-core biopsy scheme and which patients benefit most from such additional samples. METHODS: One thousand and ninety-one consecutive patients scheduled for first ultrasound-guided transrectal prostate biopsy prospectively underwent a 18-core biopsy scheme, including the traditional sextant (6-core), 4 lateral peripheral (10-core), 4 paramedian peripheral (14-core) and additional 4 lateral peripheral cores (18-core). RESULTS: The CDR of the 6-, 10-, 14- and 18-core schemes was 33.1, 39.2, 41.6 and 41.8 %, respectively; the difference between the 10- and 6-core scheme reached significance (p < 0.005), whereas that between the 18- or 14- and the 10-core scheme did not. The percentage of tumors diagnosed on the sole basis of the 14-core scheme was significantly greater in patients with low PSA (≤ 7.2 vs. >7.2 ng/ml: 12.1 vs. 1.8 %; p < 0.0001), large prostate volume (≥ 50 vs. <50 cc: 3.4 vs. 9.1 %; p = 0.011) and particularly low PSA density (<0.15 vs. ≥ 0.15: 15.9 vs. 1 %; p < 0.0001). The 18-core scheme did not provide diagnostic advantages in any patients' population. CONCLUSIONS: The addition of 4 lateral peripheral samples did not increase the CDR of the 10-core biopsy scheme. The addition of four paramedian peripheral samples was beneficial only in patients with PSA density <0.15, in whom the 10-core scheme would have miss almost 16 % of tumors. Since more than half of our patients had low (<0.15) PSA density, these findings seem to be of great clinical relevance.

Spatial distribution of positive cores improves the selection of patients with low-risk prostate cancer as candidates for active surveillance.

OBJECTIVE: To test the hypothesis that spatial distribution of positive cores at biopsy is a predictor of unfavourable prostate cancer characteristics at radical prostatectomy (RP) in active surveillance (AS) candidates. PATIENTS AND METHODS: We examined the data of 524 patients treated with RP, between 2000 and 2012. All fulfilled at least one of four commonly used AS criteria. Regression models tested the relationship between positive cores spatial distribution, defined as the number of positive zones at biopsy (PBxZ) and tumour laterality at biopsy and two endpoints: (i) unfavourable prostate cancer at RP (Gleason score ≥ 4 + 3, and/or pT3 disease), and (ii) clinically significant prostate cancer (tumour volume ≥ 2.5 mL). RESULTS: Unfavourable prostate cancer and clinically significant prostate cancer rates were 8 and 25%, respectively. Patients with more than one PBxZ had a 3.2-fold higher risk of harbouring unfavourable prostate cancer, and a 2.3-fold higher risk of harbouring clinically significant prostate cancer compared with their counterparts with one PBxZ (both P = 0.01). Patients with bilateral tumour at biopsy had a 3.3-fold higher risk of harbouring unfavourable prostate cancer and a 1.7-fold higher risk of harbouring clinically significant prostate cancer compared with their counterparts with unilateral tumour at biopsy (both P ≤ 0.04). Some of these results did not reach a statistically significant level, when the analyses were restricted to patients that fulfilled the most stringent AS criteria. CONCLUSIONS: Positive cores spatial distribution at biopsy should be considered, when advising patients about AS. The addition of this predictor to AS inclusion criteria can help identifying patients at a higher risk of progression, and reduce the rate of inappropriate surveillance of aggressive tumours. However, the most stringent AS criteria (namely John-Hopkins criteria and Prostate Cancer Research International: Active Surveillance criteria) might not benefit from the addition of this predictor. This point warrants further investigation in future studies.

Systematic review of complications of prostate biopsy.

CONTEXT: Prostate biopsy is commonly performed for cancer detection and management. The benefits and risks of prostate biopsy are germane to ongoing debates about prostate cancer screening and treatment. OBJECTIVE: To perform a systematic review of complications from prostate biopsy. EVIDENCE ACQUISITION: A literature search was performed using PubMed and Embase, supplemented with additional references. Articles were reviewed for data on the following complications: hematuria, rectal bleeding, hematospermia, infection, pain, lower urinary tract symptoms (LUTS), urinary retention, erectile dysfunction, and mortality. EVIDENCE SYNTHESIS: After biopsy, hematuria and hematospermia are common but typically mild and self-limiting. Severe rectal bleeding is uncommon. Despite antimicrobial prophylaxis, infectious complications are increasing over time and are the most common reason for hospitalization after biopsy. Pain may occur at several stages of prostate biopsy and can be mitigated by anesthetic agents and anxiety-reduction techniques. Up to 25% of men have transient LUTS after biopsy, and <2% have frank urinary retention, with slightly higher rates reported after transperineal template biopsy. Biopsy-related mortality is rare. CONCLUSIONS: Preparation for biopsy should include antimicrobial prophylaxis and pain management. Prostate biopsy is frequently associated with minor bleeding and urinary symptoms that usually do not require intervention. Infectious complications can be serious, requiring prompt management and continued work into preventative strategies.