F. Mele

Randomised Controlled Trial Comparing Laparoscopic and Robot-assisted Radical Prostatectomy

BACKGROUND The advantages of robot-assisted radical prostatectomy (RARP) over laparoscopic radical prostatectomy (LRP) have rarely been investigated in randomised controlled trials. OBJECTIVE To compare RARP and LRP in terms of the functional, perioperative, and oncologic outcomes. The main end point of the study was changes in continence 3 mo after surgery. DESIGN, SETTING, AND PARTICIPANTS From January 2010 to January 2011, 120 patients with organ-confined prostate cancer were enrolled and randomly assigned (using a randomisation plan) to one of two groups based on surgical approach: the RARP group and the LRP group. INTERVENTION All RARP and LRP interventions were performed with the same technique by the same single surgeon. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The demographic, perioperative, and pathologic results, such as the complications and prostate-specific antigen (PSA) measurements, were recorded and compared. Continence was evaluated at the time of catheter removal and 48 h later, and continence and potency were evaluated after 1, 3, 6, and 12 mo. The student t test, Mann-Whitney test, χ(2) test, Pearson χ(2) test, and multiple regression analysis were used for statistics. RESULTS AND LIMITATIONS The two groups (RARP: n=60; LRP: n=60) were comparable in terms of demographic data. No differences were recorded in terms of perioperative and pathologic results, complication rate, or PSA measurements. The continence rate was higher in the RARP group at every time point: Continence after 3 mo was 80% in the RARP group and 61.6% in the LRP group (p=0.044), and after 1 yr, the continence rate was 95.0% and 83.3%, respectively (p=0.042). Among preoperative potent patients treated with nerve-sparing techniques, the rate of erection recovery was 80.0% and 54.2%, respectively (p=0.020). The limitations included the small number of patients. CONCLUSIONS RARP provided better functional results in terms of the recovery of continence and potency. Further studies are needed to confirm our results.

The Roles of Multiparametric Magnetic Resonance Imaging, PCA3 and Prostate Health Index—Which is the Best Predictor of Prostate Cancer after a Negative Biopsy?

PURPOSE In patients with a negative prostate biopsy and persistent suspicion of prostate cancer, additional analyses such as the PCA3 score, PHI and multiparametric magnetic resonance imaging have been proposed to reduce the number of unnecessary repeat biopsies. In this study we evaluate the diagnostic accuracy of PCA3, PHI, multiparametric magnetic resonance imaging and various combinations of these tests in the repeat biopsy setting. MATERIALS AND METHODS A total of 170 patients with an initial negative prostate biopsy and persistent suspicion of prostate cancer were enrolled in this prospective study. The patients underwent measurements of the total prostate specific antigen and free prostate specific antigen rate, along with PHI, PCA3 tests and multiparametric magnetic resonance imaging before standard repeat biopsy that was performed by urologists blinded to the multiparametric magnetic resonance imaging results. Multivariate logistic regression models with various combinations of PCA3, PHI and multiparametric magnetic resonance imaging were used to identify the predictors of prostate cancer with repeat biopsy, and the performance of these models was compared using ROC curves, AUC analysis and decision curve analysis. RESULTS In the ROC analysis the most significant contribution was provided by multiparametric magnetic resonance imaging (AUC 0.936), which was greater than the contribution of the PHI+PCA3 model (p <0.001). In the multivariate logistic regression analysis only multiparametric magnetic resonance imaging was a significant independent predictor of prostate cancer diagnosis with repeat biopsy (p <0.001). The results of the decision curve analysis confirmed that the most significant improvement in the net benefit was provided by multiparametric magnetic resonance imaging. CONCLUSIONS Multiparametric magnetic resonance imaging provides high diagnostic accuracy in identifying patients with prostate cancer in the repeat biopsy setting compared with PCA3 and PHI.

Diagnostic Pathway with Multiparametric Magnetic Resonance Imaging Versus Standard Pathway: Results from a Randomized Prospective Study in Biopsy-naïve Patients with Suspected Prostate Cancer

BACKGROUND An approach based on multiparametric magnetic resonance imaging (mpMRI) might increase the detection rate (DR) of clinically significant prostate cancer (csPCa). OBJECTIVE To compare an mpMRI-based pathway with the standard approach for the detection of prostate cancer (PCa) and csPCa. DESIGN, SETTING, AND PARTICIPANTS Between November 2014 and April 2016, 212 biopsy-naïve patients with suspected PCa (prostate specific antigen level ≤15 ng/ml and negative digital rectal examination results) were included in this randomized clinical trial. Patients were randomized into a prebiopsy mpMRI group (arm A, n=107) or a standard biopsy (SB) group (arm B, n=105). INTERVENTION In arm A, patients with mpMRI evidence of lesions suspected for PCa underwent mpMRI/transrectal ultrasound fusion software-guided targeted biopsy (TB) (n=81). The remaining patients in arm A (n=26) with negative mpMRI results and patients in arm B underwent 12-core SB. OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS The primary end point was comparison of the DR of PCa and csPCa between the two arms of the study; the secondary end point was comparison of the DR between TB and SB. RESULTS AND LIMITATIONS The overall DRs were higher in arm A versus arm B for PCa (50.5% vs 29.5%, respectively; p=0.002) and csPCa (43.9% vs 18.1%, respectively; p<0.001). Concerning the biopsy approach, that is, TB in arm A, SB in arm A, and SB in arm B, the overall DRs were significantly different for PCa (60.5% vs 19.2% vs 29.5%, respectively; p<0.001) and for csPCa (56.8% vs 3.8% vs 18.1%, respectively; p<0.001). The reproducibility of the study could have been affected by the single-center nature. CONCLUSIONS A diagnostic pathway based on mpMRI had a higher DR than the standard pathway in both PCa and csPCa. PATIENT SUMMARY In this randomized trial, a pathway for the diagnosis of prostate cancer based on multiparametric magnetic resonance imaging (mpMRI) was compared with the standard pathway based on random biopsy. The mpMRI-based pathway had better performance than the standard pathway.

Standard vs mini-laparoscopic pyeloplasty: perioperative outcomes and cosmetic results

Study Type – Therapy (case series)

High prostate cancer gene 3 (PCA3) scores are associated with elevated Prostate Imaging Reporting and Data System (PI-RADS) grade and biopsy Gleason score, at magnetic resonance imaging/ultrasonography fusion software-based targeted prostate biopsy after a previous negative standard biopsy.

To determine the association among prostate cancer gene 3 (PCA3) score, Prostate Imaging Reporting and Data System (PI‐RADS) grade and Gleason score, in a cohort of patients with elevated prostate‐specific antigen (PSA), undergoing magnetic resonance imaging/ultrasonography fusion software‐based targeted prostate biopsy (TBx) after a previous negative randomised ‘standard’ biopsy (SBx).

Pure Mini-laparoscopic Transperitoneal Pyeloplasty in an Adult Population: Feasibility, Safety, and Functional Results After One Year of Follow-up

OBJECTIVE To report the results of mini-laparoscopic pyeloplasty (mLP) in an adult population. The feasibility of pure mLP has been previously reported in children. MATERIAL AND METHODS From April 2009 to February 2010, 10 patients with ureteropelvic junction obstruction (UPJO) were enrolled in this prospective study and underwent pure mLP (using only 3-mm instruments) according to the Anderson-Hynes technique. Inclusion criteria were: age >18 years, body mass index <25, primary UPJO, and no previous surgery on the affected kidney or a history of major abdominal surgery. Demographic and perioperative data, as well as 1-, 3-, 6-, and 12-month follow-up data were collected. RESULTS The mean operative time was 134 minutes, and blood loss was negligible. All procedures but one were completed using only 3.9-mm ports and 3-mm instruments. No perioperative complications occurred, and no patients had computed tomography evidence of hydronephrosis at 6 months after surgery. No functional obstructions were visualized with renal scintigraphy at 12 months after surgery. All patients were satisfied with the intervention and with their cosmetic results, as assessed by the Patient Scar Assessment Questionnaire and Scoring System. CONCLUSIONS The results of our study suggest that pure mLP in an adult population is feasible and seems to be safe and effective in the treatment of UPJO. Furthermore, the patients tolerated the procedure well and appreciated its excellent cosmetic results. Further studies are required to determine the true advantages of mLP over standard laparoscopy.

High PCA3 scores are associated to elevated Prostate Imaging Reporting and Data System (PI-RADS) grade and biopsy Gleason Score, at MRI/US fusion software-based targeted prostate biopsy after a previous negative standard biopsy.

To determine the association among prostate cancer gene 3 (PCA3) score, Prostate Imaging Reporting and Data System (PI‐RADS) grade and Gleason score, in a cohort of patients with elevated prostate‐specific antigen (PSA), undergoing magnetic resonance imaging/ultrasonography fusion software‐based targeted prostate biopsy (TBx) after a previous negative randomised ‘standard’ biopsy (SBx).

Multiparametric magnetic resonance imaging and active surveillance: How to better select insignificant prostate cancer?

To evaluate the role of multiparametric magnetic resonance imaging in improving the predictive accuracy of the Prostate Cancer Research International: Active Surveillance and Epstein criteria for active surveillance in prostate cancer.

Multiparametric Magnetic Resonance/Ultrasound Fusion Prostate Biopsy: Number and Spatial Distribution of Cores for Better Index Tumor Detection and Characterization

Purpose: We evaluated the minimum core number for better index tumor detection to determine the best core site as well as biopsy Gleason score heterogeneity in the same index lesion. The aim was to optimize the highest Gleason score detection. Materials and Methods: A total of 327 patients with negative digital rectal examination underwent magnetic resonance imaging/transrectal ultrasound fusion targeted biopsy for elevated/rising prostate specific antigen and/or 1 or more detectable lesions on multiparametric magnetic resonance imaging after a previous negative standard biopsy. Depending on the diameter of each index lesion (8 or less, or greater than 8 mm) 4 or 6 cores, respectively, were taken according to a well determined sequence. Results: Of the patients 166 (50.7%) had prostate cancer, including 79 (47.6%) with an 8 mm or less index lesion and 87 (52.4%) with a greater than 8 mm index lesion. Of patients with an index tumor 8 mm or less 7 (8.9%) had 1, 31 (39.2%) had 2, 27 (34.2%) had 3 and 14 (17.7%) had 4 positive cores. Similarly, of patients with a lesion greater than 8 mm 8 (9.2%) had 1, 30 (34.5%) had 2, 13 (14.9%) had 3, 14 (16.1%) had 4, 12 (13.8%) had 5 and 10 (11.5%) had 6 positive cores. The major prevalence of positive cores was observed in the center of the target. Gleason score heterogeneity was found in 12.6% of those with an 8 mm or less target vs 26.4% with a target greater than 8 mm. In the center of the target there was a slight prevalence of Gleason pattern 4 or greater, or a lesser pattern. Conclusions: Approaching magnetic resonance imaging/transrectal ultrasound fusion targeted biopsy with a single core might be inadequate. Rather, taking 2 cores in the center of the index lesion may provide more accurate cancer detection and optimize the chances of finding the highest Gleason pattern.

Preoperative prostate biopsy and multiparametric magnetic resonance imaging: Reliability in detecting prostate cancer

Purpose The aim of the study was to analyse and compare the ability of multiparametric magnetic resonance imaging (mp–MRI) and prostate biopsy (PB) to correctly identify tumor foci in patients undergoing radical prostatectomy (RP) for prostate cancer (PCa). Materials and Methods 157 patients with clinically localised PCa with a PSA <10 ng/mL and a negative DRE diagnosed on the first (12 samples, Group A) or second (18 samples, Group B) PB were enrolled at our institution. All patients underwent mp-MRI with T2-weighted images, diffusion-weighted imaging, dynamic contrast enhanced-MRI prior to RP. A map of comparison describing each positive biopsy sample was created for each patient, with each tumor focus shown on the MRI and each lesion present on the definitive histological examination in order to compare tumor detection and location. The sensitivity of mp-MRI and PB for diagnosis was compared using Student’s t-test. The ability of the two exams to detect the prevalence of Gleason pattern 4 in the identified lesions was compared using a chi-square test. Results Overall sensitivity of PB and mp-MRI to identify tumor lesion was 59.4% and 78.9%, respectively (p<0.0001). PB missed 144/355 lesions, 59 of which (16.6%) were significant. mp-MRI missed 75/355 lesions, 12 of which (3.4%) were significant. No lesions with a GS≥8 were missed. Sensitivity of PB and mp-MRI to detect the prevalence of Gleason pattern 4 was 88.2% and 97.4%, respectively. Conclusions mp-MRI seems to identify more tumor lesions than PB and to provide more information concerning tumor characteristics.