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Purpose 68 Ga labeled prostate specific membrane antigen positron emission tomography/computerized tomography may represent the most promising imaging modality to identify and risk stratify prostate cancer in patients with contraindications to or negative multiparametric magnetic resonance imaging. Materials and Methods In this prospective observational study we analyzed 68 Ga labeled prostate specific membrane antigen positron emission tomography/computerized tomography in a select group of patients with persistently elevated prostate specific antigen and/or Prostate Health Index suspicious for prostate cancer, negative digital rectal examination and at least 1 negative biopsy. The cohort comprised men with equivocal multiparametric magnetic resonance imaging (Prostate Imaging-Reporting and Data System, version 2 score of 2 or less), or an absolute or relative contraindication to multiparametric magnetic resonance imaging. Sensitivity, specificity and CIs were calculated compared to histopathology findings. ROC analysis was applied to determine the optimal cutoff values of 68 Ga labeled prostate specific membrane antigen uptake to identify clinically significant prostate cancer (Gleason score 7 or greater). Results A total of 45 patients with a median age of 64 years were referred for 68 Ga labeled prostate specific membrane antigen positron emission tomography/computerized tomography between January and August 2017. The 25 patients (55.5%) considered to have positive positron emission tomography results underwent software assisted fusion biopsy. We determined the uptake values of regions of interest, including a median maximum standardized uptake value of 5.34 (range 2.25 to 30.41) and a maximum-to-background standardized uptake value ratio of 1.99 (range 1.06 to 14.42). Mean and median uptake values on 68 Ga labeled prostate specific membrane antigen positron emission tomography/computerized tomography (ie the maximum standardized uptake value or the maximum-to-background standardized uptake value ratio) were significantly higher for Gleason score 7 lesions than for Gleason score 6 or benign lesions (p <0.001). On ROC analysis a maximum standardized uptake value of 5.4 and a maximum-to-background standardized uptake value ratio of 2 discriminated clinically relevant prostate cancer with 100% overall sensitivity in each case, and 76% and 88% specificity, respectively. Conclusions Our findings support the use of 68 Ga labeled prostate specific membrane antigen positron emission tomography/computerized tomography for primary detection of prostate cancer in a specific subset of men. [ABSTRACT FROM AUTHOR]

Purpose We investigated predictive factors of failure and performed a resource consumption analysis in patients who underwent active surveillance for nonmuscle invasive bladder cancer. Materials and Methods This prospective observational study monitored patients with a history of pathologically confirmed stage pTa (grade 1-2) or pT1a (grade 2) nonmuscle invasive bladder cancer, and recurrent small size and number of tumors without hematuria and positive urine cytology. The primary end point was the failure rate of active surveillance. Assessment of failure predictive variables and per year direct hospital resource consumption analysis were secondary outcomes. Descriptive statistical analysis and Cox regression with univariable and multivariable analysis were done. Results Of 625 patients with nonmuscle invasive bladder cancer 122 with a total of 146 active surveillance events were included in the protocol. Of the events 59 (40.4%) were deemed to require treatment after entering active surveillance. Median time on active surveillance was 11 months (IQR 5–26). Currently 76 patients (62.3%) remain under observation. On univariable analysis only time from the first transurethral resection to the start of active surveillance seemed to be inversely associated with recurrence-free survival (HR 0.99, 95% CI 0.98–1.00, p = 0.027). Multivariable analysis also revealed an association with age at active surveillance start (HR 0.97, 95% CI 0.94–1.00, p = 0.031) and the size of the lesion at the first transurethral resection (HR 1.55, 95% CI 1.06–2.27, p = 0.025). The average specific annual resource consumption savings for each avoided transurethral bladder tumor resection was €1,378 for each intervention avoided. Conclusions Active surveillance might be a reasonable clinical and cost-effective strategy in patients who present with small, low grade pTa/pT1a recurrent papillary bladder tumors. [ABSTRACT FROM AUTHOR]

Purpose We investigated deterioration of the success rate of penile and bulbar substitution urethroplasty. Materials and Methods We performed a retrospective descriptive analysis of patients who underwent substitution urethroplasty between July 1994 and September 2007. Inclusion criteria included 1-stage anterior urethroplasty using penile skin or oral mucosa with a minimum of 6 years followup. Patients with posterior urethral stricture, failed hypospadias or incomplete clinical records were excluded from analysis. The primary study outcome was postoperative failure-free survival and the secondary outcome was to identify significant predictors of treatment failure. The clinical outcome was considered a failure when any postoperative instrumentation was needed. Descriptive statistical analysis was done as well as Kaplan-Meier analysis, and univariable and multivariable Cox regression analysis. Results A total of 359 patients were included in study. Median followup was 118 months. Of the procedures 265 (73.8%) were successful and 94 (26.2%) failed, including 91 (96.8%) within the first 5 years. Substitute tissue type (oral mucosa vs skin) was the only significant predictor on univariable analysis (HR 1.86, p = 0.005). This result was confirmed by multivariable analysis adjusting for age at surgery, stricture length and etiology, urethroplasty type and previous treatments (HR 2.26, p = 0.001). Conclusions Deterioration after anterior 1-stage substitution urethroplasty seems to develop within the first 5 years. Oral mucosa showed greater failure-free survival than penile skin and 1-stage penile urethroplasty showed the same success rate as bulbar urethroplasty. [ABSTRACT FROM AUTHOR]

Purpose: We investigated the early and late complications after oral mucosal graft harvesting, and reported the independent predictors of outcome via multivariable analysis. Materials and Methods: We performed a retrospective descriptive study of 553 patients from whom an oral mucosa graft was harvested for urethroplasty from single or bilateral cheeks. Patients who underwent oral mucosa harvesting from the lip, the tongue or from the cheek and lip at the same time were excluded from analysis. The oral graft was harvested in an ovoid shape with closure of the wound. Postoperative early and late complications were investigated using a self-administered, nonvalidated, semiquantitative questionnaire. There were 6 questions on early complications, and 13 questions investigated late complications and patient satisfaction. Results: Descriptive statistics of categorical variables focused on frequencies and proportions. Univariable and multivariable analyses were used to predict early and late dissatisfaction of patients. Bleeding was reported in 3.4% of patients. Overall 53.2% of patients did not report any pain and 36.3% reported no swelling. Late complications analysis showed that 95.5% of patients declared that the surgical closure of the wound did not cause any difficulty in opening the mouth or problems with smiling (98.2%) and/or dry mouth (95.8%). Overall 98.2% of patients were satisfied with the procedure. Univariable and multivariable analyses revealed that bilateral graft harvesting was the only significant predictor of patient dissatisfaction (OR 2.85, p = 0.01 and OR 2.72, p = 0.02; respectively). Conclusions: Harvesting the oral mucosa ovoid graft from a single cheek with closure of the wound is a safe procedure with high rates of patient satisfaction. [ABSTRACT FROM AUTHOR]

Purpose: We performed a head-to-head comparison of the PHI (Prostate Health Index) and PCA3. Materials and Methods: We evaluated PHI and PCA3 performance in 211 patients undergoing initial (116) or repeat (95) prostate biopsy. Multivariable logistic regression analysis was done using the AUC to test the accuracy of PHI and PCA3 for predicting prostate cancer in the overall population and in each setting. Decision curve analysis was used to compare the clinical benefit of different models. Results: Overall, the AUC of the PHI (0.70) was significantly higher than the AUC of PCA3 (0.59), total prostate specific antigen (0.56) and free-to-total prostate specific antigen (0.60) (p = 0.043, 0.002 and 0.037, respectively). PHI was more accurate than PCA3 for predicting prostate cancer in the initial setting (AUC 0.69 vs 0.57) and in the repeat setting (AUC 0.72 vs 0.63), although no statistically significant difference was observed. Including PCA3 in the base multivariable model (prostate specific antigen plus free-to-total prostate specific antigen plus prostate volume) did not increase predictive accuracy in either setting (AUC 0.79 vs 0.80 and 0.75 vs 0.76, respectively). Conversely, including PHI in the base multivariable model improved predictive accuracy by 5% (AUC 0.79 to 0.84) and 6% (AUC 0.75 to 0.81) in the initial and repeat prostate biopsy settings, respectively. On decision curve analysis the highest net benefit was observed when PHI was added to the base multivariable model. Conclusions: PHI and PCA3 provide a significant increase in sensitivity and specificity compared to all other examined markers and they may help guide biopsy decisions. PCA3 does not increase the accuracy of predicting prostate cancer when PHI is assessed. [ABSTRACT FROM AUTHOR]

Purpose: We developed and validated a Prostate Health Index (Beckman Coulter, Brea, California) based nomogram to predict prostate cancer at extended prostate biopsy. Materials and Methods: The study population consisted of 729 patients who were scheduled for prostate biopsy following suspicious digital rectal examination and/or increased prostate specific antigen. Total and free prostate specific antigen, percent free-to-total prostate specific antigen, [–2]proPSA and the prostate health index [([–2]proPSA/free prostate specific antigen) × √total prostate specific antigen)] were determined. Logistic regression models were fitted to test prostate cancer predictors. Predictive accuracy estimates of biopsy outcome predictions were quantified. Regression coefficients were used to create a decision making tool to predict prostate cancer. A calibration plot was used to evaluate the extent of overestimating or underestimating the observed prostate cancer rate. Decision curve analysis provided an estimate of the net benefit obtained using the prostate health index based nomogram. Results: Overall 280 of 729 patients (38.4%) were diagnosed with prostate cancer at extended prostate biopsy. On accuracy analyses prostate health index emerged as the most informative predictor of prostate cancer (AUC 0.70) compared to established predictors, such as total prostate specific antigen (0.51) and percent free-to-total prostate specific antigen (0.62). Including the prostate health index in a multivariable logistic regression model based on patient age, prostate volume, digital rectal examination and biopsy history significantly increased predictive accuracy by 7% from 0.73 to 0.80 (p <0.001). Nomogram calibration was good. Decision curve analysis showed that using the prostate health index based nomogram resulted in the highest net benefit. Conclusions: The prostate health index based nomogram can assist clinicians in the decision to perform biopsy by providing an accurate estimation of an individual risk of prostate cancer. [Copyright &y& Elsevier]

Purpose: We tested the hypothesis that serum isoform [-2]proPSA derivatives %p2PSA and Prostate Health Index are accurate predictors of prostate cancer in men scheduled for repeat biopsy. Materials and Methods: The study was an observational prospective evaluation of a clinical cohort of men with 1 or 2 previous negative prostate biopsies, with persistent suspicion of prostate cancer. They were enrolled in the study to determine the diagnostic accuracy of %p2PSA using the formula, (p2PSA pg/ml)/(free prostate specific antigen ng/ml × 1,000)]× 100, and Beckman-Coulter Prostate Health Index using the formula, (p2PSA/free prostate specific antigen) × √total prostate specific antigen), and to compare it with the accuracy of established prostate cancer serum tests (total prostate specific antigen, free prostate specific antigen and percent free prostate specific antigen). Multivariable logistic regression models were complemented by predictive accuracy analysis and decision curve analysis. Results: Prostate cancer was found in 71 of 222 (31.9%) subjects. %p2PSA and Prostate Health Index were the most accurate predictors of disease. %p2PSA significantly outperformed total prostate specific antigen, free prostate specific antigen, percent free prostate specific antigen and p2PSA in the prediction of prostate cancer (p ≤0.01), but not Prostate Health Index (p = 0.094). Prostate Health Index significantly outperformed total prostate specific antigen and p2PSA (p ≤0.001) but not free prostate specific antigen (p = 0.109) and free/total prostate specific antigen (p = 0.136). In multivariable logistic regression models %p2PSA and Prostate Health Index achieved independent predictor status, and significantly increased the accuracy of multivariable models including prostate specific antigen and prostate volume with or without percent free prostate specific antigen and prostate specific antigen density by 8% to 11% (p ≤0.034). At a %p2PSA cutoff of 1.23, 153 (68.9%) biopsies could have been avoided, missing prostate cancer in 6 patients. At a Prostate Health Index cutoff of 28.8, 116 (52.25%) biopsies could have been avoided, missing prostate cancer in 6 patients. Conclusions: Serum %p2PSA and Prostate Health Index are more accurate than standard reference tests in predicting repeat prostate biopsy outcome, and could avoid unnecessary repeat biopsies. [Copyright &y& Elsevier]

Purpose: The association between baseline functional status and urinary continence recovery after radical prostatectomy remains controversial. We tested the hypothesis that baseline erectile and urinary function predicts urinary continence recovery after bilateral nerve sparing radical prostatectomy. Materials and Methods: The study included 752 patients with prostate cancer treated with bilateral nerve sparing radical prostatectomy between 2003 and 2009. All patients had preoperative functional and oncological data available, including age at surgery, body mass index, prostate specific antigen, and erectile and urinary function. Preoperatively erectile and urinary function was assessed by the erectile function domain of the International Index of Erectile Function and the International Prostatic Symptoms Score. Urinary continence was defined as wearing no pads. Univariate and multivariate Cox regression models were used to test the association between predictors and urinary continence recovery after surgery. Results: At a mean postoperative followup of 30.7 months (median 29, range 1 to 80) 611 patients (81.3%) had recovered urinary continence. Overall the urinary continence recovery rate at 1 and 3 years was 73.9% and 82.2%, respectively. On univariate Cox regression analysis patient age and the preoperative score on the erectile function domain of the International Index of Erectile Function were significantly associated with urinary continence recovery (each p ≤0.04). On multivariate analysis age at surgery and the preoperative erectile function domain of the International Index of Erectile Function were the only independent predictors of urinary continence recovery after bilateral nerve sparing radical prostatectomy (each p ≤0.04). Conclusions: Age and preoperative erectile function should be considered for urinary continence predictions after bilateral nerve sparing radical prostatectomy and for accurate patient counseling before surgery. Preoperative erectile function might be a marker of pelvic vascular disease, which may affect the status of the external urinary sphincter. [ABSTRACT FROM AUTHOR]

Purpose: We assessed the opinions of patients with nongerm cell urological cancer on sperm banking before undergoing surgical or nonsurgical therapy that could potentially endanger subsequent fertility. Materials and Methods: Between April 2007 and July 2008, 753 patients visited a urological office and were invited to complete a brief self-administered questionnaire to assess opinions on sperm banking before undergoing any eventual therapy potentially dangerous for male fertility. Logistic regression models tested the association between predictors (age, educational level, relationship status, previous fatherhood and benign disorder vs nongerm cell urological cancer) and patient wishes for sperm banking. Results: Median patient age was 65 years (mean 61.6, range 18 to 76). Overall 522 patients (69.3%) had nongerm cell urological cancer and only 242 (32.1%) were in favor of pretreatment sperm banking. On univariate analysis age (OR 0.961, p <0.001), a stable relationship (OR 0.486, p <0.001) and previous fatherhood (OR 0.390, p <0.001) were inversely associated with the wish for sperm banking, whereas having cancer and educational status were not significantly correlated. Multivariate analysis indicated that aging (OR 0.966, p = 0.001) and previous fatherhood (OR 0.587, p = 0.029) maintained inverse associations. Having urological cancer was positively (OR 1.494, p = 0.045) associated with the wish for sperm banking. Conclusions: In urological patients there is a low rate of willingness to bank sperm before any potential fertility damaging therapeutic approach. Having nongerm cell urological cancer is an independent predictor that is positively associated with the wish to bank sperm. It is vitally important to provide comprehensive information about pretreatment sperm banking to young adults with nongerm cell urological cancer. [Copyright &y& Elsevier]

Purpose: According to the 2002 American Joint Committee on Cancer TNM classification, perinephric and renal sinus fat invasion are classified as pT3a renal cell carcinoma. However, only a few studies have assessed the impact of sinus fat invasion on patient survival and with controversial results. We analyzed the impact of sinus fat invasion on cancer specific survival in a cohort of patients with pT3a clear cell renal cell carcinoma. Materials and Methods: We retrospectively analyzed data on 115 consecutive patients treated with open radical nephrectomy for unilateral, sporadic pT3a clear cell renal cell carcinoma at our department from 1989 to 2006. All pathological specimens were rereviewed by a single uropathologist. The prognostic role of sinus fat invasion in cancer specific survival was assessed by Cox proportional hazards regression models. Results: Ten patients had direct ipsilateral adrenal invasion and were excluded from analysis. A total of 105 patients with clear cell renal cell carcinoma were evaluated. Median followup was 38 months. In the overall population sinus fat invasion did not reach independent predictive status in terms of cancer specific survival on multivariate Cox regression analysis after adjusting for age, performance status, tumor dimension, tumor grade, synchronous metastases, nodal involvement, sarcomatoid differentiation and coagulative necrosis. In the subset of patients with pNx/pN0 M0 (83) the actuarial 5-year cancer specific survival was 71.9% and 45.5% for those with perinephric fat invasion only and sinus fat invasion, respectively (p = 0.025). Sinus fat invasion achieved an independent predictive role on multivariable Cox regression analysis (p = 0.048, HR 2.06). Conclusions: Sinus fat invasion in clear cell renal cell carcinoma significantly affects cancer specific survival in patients without nodal or distant metastases. However, sinus fat invasion is not associated with worse cancer specific survival in cases of metastatic disease. [Copyright &y& Elsevier]

Purpose: We retrospectively investigated the detection rates of prostate cancer, high grade prostatic intraepithelial neoplasia and atypical glands suggestive of carcinoma by initial 18 and 12-core prostate biopsy. Materials and Methods: A total of 3,460 consecutive patients with prostate specific antigen between 2.5 and 15 ng/ml underwent 12 (1,684) or 18 (1,776) core prostate biopsy under local anesthesia at 2 departments that adopted the same indications for performing biopsy. Biopsies were evenly distributed throughout the prostate in 6 sectors. In the 12-core prostate biopsy group 2 samples were obtained from each sector and in the 18-core prostate biopsy group 1 additional core was taken from each sector. Results: The cancer detection rate in patients who underwent 18-core prostate biopsy was not different from the rate in those who underwent 12-core prostate biopsy (39.9% and 38.4%, p = 0.37), nor did the detection of atypical glands suggestive of carcinoma differ significantly between the 2 groups (2.9% and 3.3%, respectively, p = 0.33). However, 18-core prostate biopsy detected a significantly higher percent of cases of high grade prostatic intraepithelial neoplasia (20.0% vs 12.9%, p = 0.001). The cancer detection rate was higher with 18 than with 12-core prostate biopsy in patients with a prostate volume of 55 cc or greater (31.5% vs 24.8%, p = 0.01) but not in those with a prostate volume of less than 55 cc (54.3% and 53.0%, respectively, p = 0.7). Moreover, we determined that patients with positive digital rectal examination findings do not need 18-core prostate biopsy as opposed to 12-core prostate biopsy. Conclusions: Compared with 12-core prostate biopsy, 18-core prostate biopsy detects significantly more cases of high grade prostatic intraepithelial neoplasia. However, 18-core prostate biopsy detects a significantly higher number of cancer only in patients with a prostate volume of 55 cc or greater. [Copyright &y& Elsevier]

Purpose: We retrospectively reviewed patterns of failure after bulbar substitution urethroplasty. In particular we investigated the prevalence and location of anastomotic fibrous ring strictures occurring at the apical anastomoses between the graft and urethral plate after 3 types of onlay graft techniques. Materials and Methods: We reviewed the records of 107 patients who underwent bulbar urethroplasty between 1994 and 2004. Mean patient age was 44 years. Patients with lichen sclerosus, failed hypospadias repair or urethroplasty and panurethral strictures were excluded. A total of 45 patients underwent dorsal onlay skin graft urethroplasty, 50 underwent buccal mucosa onlay graft urethroplasty and 12 underwent augmented end-to-end urethroplasty. The clinical outcome was considered a success or failure at the time that any postoperative procedure was needed, including dilation. Mean followup was 74 months (range 12 to 130). Results: Of 107 cases 85 (80%) were successful and 22 (20%) failed. Failure in 12 patients (11%) involved the whole grafted area and in 10 (9%) it involved the anastomotic site, which was distal and proximal in 5 each. Urethrography, urethral ultrasound and urethroscopy were fundamental for determining the difference between full-length and focal extension of re-stricture. Failures were treated with multistage urethroplasty in 12 cases, urethrotomy in 7 and 1-stage urethroplasty in 3. Of the patients 16 had a satisfactory final outcome and 6 underwent definitive perineal urinary diversion. Conclusions: The prevalence and location of anastomotic ring strictures after bulbar urethroplasty were uniformly distributed in after 3 surgical techniques using skin or buccal mucosa. Further studies are necessary to clarify the etiology of these fibrous ring strictures. [Copyright &y& Elsevier]