Carlos Capitán

GreenLight HPS 120-W Laser Vaporization versus Transurethral Resection of the Prostate for the Treatment of Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia: A Randomized Clinical Trial with 2-year Follow-up

BACKGROUND High-level evidence to support the use of photoselective vaporization of the prostate (PVP) is limited. OBJECTIVE Assess the efficacy and safety of GreenLight HPS 120-W laser PVP compared with transurethral resection of the prostate (TURP). DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial was performed with 50 patients having lower urinary tract symptoms due to benign prostatic hyperplasia in each treatment arm. INTERVENTION Random allocation to PVP or TURP. MEASUREMENTS International Prostate Symptom Score (IPSS), quality of life (QoL), and changes in maximum flow rate (Qmax) were the main end points. Patients were evaluated at a follow-up time of 2 yr. Five patients were lost to follow-up. A last observation carried forward analysis was done. RESULTS AND LIMITATIONS Both laser PVP and TURP resulted in the same IPPS reduction at 2 yr (-15.7 and -14.9, respectively; p=0.48) and in the same gain in Qmax (+14.5 ml/s and +13.1 ml/s, respectively; p=0.65). QoL was equivalent for both treatment modalities. These results were independent of prostate size, American Society of Anesthesiologists risk category, and prior indwelling catheter. No statistically significant differences were detected between arms in terms of complication rates. In the laser PVP group, three patients were readmitted to the hospital and two developed a urethral stricture. In the TURP group, two patients were readmitted, six developed a urethral stricture, and two developed bladder neck sclerosis. In-hospital stay and time to catheter removal were significantly shorter with PVP. Limitations are the potential lack of power to detect differences in the complications between groups and the lack of blindness due to the nature of the intervention. CONCLUSIONS GreenLight HPS 120-W laser PVP is as effective as TURP for symptom reduction and improvement of QoL. No differences were seen in the response of storage and voiding symptoms. Laser PVP and TURP have the same complication rate. Length of stay is shorter for laser PVP group.

180-W XPS GreenLight Laser Vaporisation Versus Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 6-Month Safety and Efficacy Results of a European Multicentre Randomised Trial—The GOLIATH Study

BACKGROUND The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned. OBJECTIVE The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax) at 6 mo and the proportion of patients who were complication free. DESIGN, SETTING, AND PARTICIPANTS Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO. INTERVENTION 180-W GL XPS system or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Measurements used were IPSS, Qmax, prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level. RESULTS AND LIMITATIONS The study demonstrated the noninferiority of XPS to TURP for IPSS, Qmax, and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS (p<0.001). Early reintervention rate within 30 d was three times higher after TURP (p=0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up. CONCLUSIONS XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Qmax, and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo. TRIAL REGISTRATION ClinicalTrials.gov, identifier NCT01218672.

A European Multicenter Randomized Noninferiority Trial Comparing 180 W GreenLight XPS Laser Vaporization and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 12-Month Results of the GOLIATH Study

PURPOSE We present the 1-year results of the GOLIATH prospective randomized controlled trial comparing transurethral resection of the prostate to GreenLight XPS for the treatment of men with nonneurogenic lower urinary tract symptoms due to prostate enlargement. The updated results at 1 year show that transurethral resection of the prostate and GreenLight XPS remain equivalent, and confirm the therapeutic durability of both procedures. We also report 1-year followup data from several functional questionnaires (OABq-SF, ICIQ-SF and IIEF-5) and objective assessments. MATERIALS AND METHODS A total of 291 patients were enrolled at 29 sites in 9 European countries. Patients were randomized 1:1 to undergo GreenLight XPS or transurethral resection of the prostate. The trial was designed to evaluate the hypothesis that GreenLight XPS is noninferior to transurethral resection of the prostate on the International Prostate Symptom Score at 6 months. Several objective parameters were assessed, including maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen, in addition to functional questionnaires and adverse events at each followup. RESULTS Of the 291 enrolled patients 281 were randomized and 269 received treatment. Noninferiority of GreenLight XPS was maintained at 12 months. Maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen were not statistically different between the treatment arms at 12 months. The complication-free rate at 1 year was 84.6% after GreenLight XPS vs 80.5% after transurethral resection of the prostate. At 12 months 4 patients treated with GreenLight XPS and 4 who underwent transurethral resection of the prostate had unresolved urinary incontinence. CONCLUSIONS Followup at 1 year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate. The complication-free rates and overall reintervention rates were comparable between the treatment groups.

A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study

BACKGROUND The GOLIATH study is a 2-yr trial comparing transurethral resection of prostate (TURP) to photoselective vaporization with the GreenLight XPS Laser System (GL-XPS) for the treatment of benign prostatic obstruction (BPO). Noninferiority of GL-XPS to TURP was demonstrated based on a 6-mo follow-up from the study. OBJECTIVE To determine whether treatment effects observed at 6 mo between GL-XPS and TURP was maintained at the 2-yr follow-up. DESIGN, SETTING, AND PARTICIPANTS Prospective randomized controlled trial at 29 centers in nine European countries involving 281 patients with BPO. INTERVENTION Photoselective vaporization using the 180-W GreenLight GL-XPS or conventional (monopolar or bipolar) TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome was the International Prostate Symptom Score for which a margin of three was used to evaluate the noninferiority of GL-XPS. Secondary outcomes included Qmax, prostate volume, prostate specific antigen, Overactive Bladder Questionnaire Short Form, International Consultation on Incontinence Questionnaire Short Form, occurrence of surgical retreatment, and freedom from complications. RESULTS AND LIMITATIONS One hundred and thirty-six patients were treated using GL-XPS and 133 using TURP. Noninferiority of GL-XPS on International Prostate Symptom Score, Qmax, and freedom from complications was demonstrated at 6-mo and was sustained at 2-yr. The proportion of patients complication-free through 24-mo was 83.6% GL-XPS versus 78.9% TURP. Reductions in prostate volume and prostate specific antigen were similar in both arms and sustained over the course of the trial. Compared with the 1(st) yr of the study, very few adverse events or retreatments were reported in either arm. Treatment differences in the Overactive Bladder Questionnaire Short Form observed at 12-mo were not statistically significant at 24-mo. A limitation was that patients and treating physicians were not blinded to the therapy. CONCLUSIONS Twenty-four-mo follow-up data demonstrated that GL-XPS provides a durable surgical option for the treatment of BPO that exhibits efficacy and safety outcomes similar to TURP. PATIENT SUMMARY The long-term effectiveness and safety of GLP-XLS was similar to conventional TURP for the treatment of prostate enlargement.

Cambios en el grado de Gleason en las biopsias de seguimiento de pacientes con cáncer de próstata en programa de vigilancia activa

INTRODUCTION Active surveillance for prostate cancer has grown systematically in the recent years with more robust mid-term outcomes. However, changes in Gleason score during serial biopsies are not detailed in many of these reports. OBJECTIVES To evaluate changes in Gleason score on follow-up biopsies in low-risk prostate cancer in patients undergoing AS program in our center. MATERIAL AND METHODS Series of patients diagnosed of prostate cancer between 2004 and 2013 have been analyzed. The inclusion criteria were: PSA ≤ 10 ng/ml + Gleason ≤ 6 + T1c/T2a + ≤ 2 positive cores, and no more than 50% of affected core. The pathology of each of the biopsies was analyzed. RESULTS We studied a series of 175 patients undergoing AS. Mean follow-up was 3.96 years (SD 2.4). Follow-up biopsies with Gleason scores ≥ 7 were: 5.72% in the first biopsy, 7.39% and 7.41% in subsequent biopsies. By contrast, in 42.03% of cases did not show evident tumor involvement in the first biopsy, 40.74% and 51.85% in the second and third biopsies respectively. Median stay in the AS program was: 90.99 months (95% CI: 53.53-128.46) in patients with first positive biopsy vs. 96.66 months (95% CI: 63.19-130.13) in those without evidence of tumor. CONCLUSIONS In our series the pathological data of the first 3 biopsies remain stable in terms of the positive biopsy rate, Gleason score, or indication of active treatment proportions. Those patients who do not show evidence of malignancy in the first follow-up biopsy are less likely to need active treatment than the other patients in the series.

1037 EXTERNAL VALIDATION AND APPLICABILITY OF THE EORTC RISK TABLES FOR NON MUSCLE-INVASIVE BLADDER CANCER

Purpose To perform an external validation of the EORTC risk tables and to evaluate their applicability in the patients of our institution by comparing the actual risk of recurrence and progression in our series to those obtained through the application of the EORTC tables.

PD5-10 TRANSURETHRAL RESECTION OF THE PROSTATE (GL-XPS OR TURP) DOES NOT RESULT IN SIGNIFICANT IMPAIRMENT OF ERECTILE FUNCTION

James Andrew Thomas*, Bridgend, Wales, United Kingdom; Andrea Tubaro, Rome, Italy; Neil Barber, Frimley, Camberley Surrey, United Kingdom; Frank d’ Ancona, Nijmegen, Netherlands; Gordon Muir, London, United Kingdom; Ulrich Witzsch, Frankfurt, Germany; Marc-Oliver Grimm, Jena, Germany; Joan Benejam, Manacor, Spain; Jens-Uwe Stolzenburg, Leipzig, Germany; Antony Riddick, Edinburgh, Scotland, United Kingdom; Sascha Pahernik, Heidelberg, Germany; Johannes Roelink, Almelo/Hengelo, Netherlands; Filip Ameye, Gent, Belgium; Christian Saussine, Strasbourg, France; Frank Bruyere, Tours, France; Wolfgang Loidl, Linz, Austria; Tim Larner, Brighton, United Kingdom; Nirjan Gogoi, Wakefield, United Kingdom; Richard Hindley, Hampshire, United Kingdom; Rolf Muschter, Rotenburg, Germany; Andrew Thorpe, Newcastle upon Tyne, United Kingdom; Nitin Shrotri, Kent, United Kingdom; Stuart Graham, London, United Kingdom; Moritz Hamann, Kiel, Germany; Kurt Miller, Berlin, Germany; Martin Schostak, Magdeburg, Germany; Carlos Capitan, Madrid, Spain; Helmut Knispel, Berlin, Germany; Alexander Bachmann, Basel, Switzerland

Weight of the resected specimen after transurethral resection as a new predictive variable for recurrence of non-muscle-invasive bladder tumour: TUR SPECIMEN WEIGHT AS PREDICTOR FOR BLADDER CANCER RECURRENCE

Whats known on the subject? and What does the study add?