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The Preoperative Use of Erythropoietin Stimulating Proteins Prior to Radical Prostatectomy Is Not Associated With Increased Cardiovascular or Thromboembolic Morbidity or Mortality REPLY [Editorial]
Lepor, H
ISI:000278221100055
ISSN: 0090-4295
CID: 110124
Recovery of erectile function after nerve sparing radical prostatectomy and penile rehabilitation with nightly intraurethral alprostadil versus sildenafil citrate
McCullough, Andrew R; Hellstrom, Wayne G; Wang, Run; Lepor, Herbert; Wagner, Kristofer R; Engel, Jason D
PURPOSE: To our knowledge we report the first large, randomized, prospective penile rehabilitation clinical trial to compare the effectiveness of nightly intraurethral alprostadil vs sildenafil citrate after nerve sparing prostatectomy. MATERIALS AND METHODS: We performed a prospective, randomized, open label, multicenter American study in men with normal erectile function who underwent bilateral nerve sparing radical prostatectomy. The International Index of Erectile Function erectile function domain was the primary end point. Subjects initiated nightly treatment within 1 month of surgery with intraurethral alprostadil or oral sildenafil citrate (50 mg) for 9 months. After 1-month washout and before sexual activity subjects self-administered sildenafil citrate (100 mg) for a total of 6 attempts in 1 month. Secondary end points were the global assessment question, sexual encounter profile, Erectile Dysfunction Inventory of Treatment Satisfaction and measured stretched penile length. RESULTS: Of 139 men who started intraurethral alprostadil and 73 who started sildenafil citrate, 97 and 59, respectively, completed the trial. There were no statistically significant differences in International Index of Erectile Function erectile function domain and intercourse success rates to intraurethral alprostadil. The global assessment question was significantly better only at 6 months for intraurethral alprostadil (p <0.028). At completion there were no differences between treatments for any of the end points. CONCLUSIONS: This is the first study to directly compare the ability of alprostadil and a phosphodiesterase-5 inhibitor to enhance penile recovery subsequent to bilateral nerve sparing radical prostatectomy. The use of nightly subtherapeutic intraurethral alprostadil is well tolerated after radical prostatectomy. The benefit to return of erectile function of nightly sildenafil citrate and subtherapeutic intraurethral alprostadil appears to be comparable within the first year of surgery
PMID: 20403617
ISSN: 1527-3792
CID: 109674
Pathologic outcomes of candidates for active surveillance undergoing radical prostatectomy
Mufarrij, Patrick; Sankin, Alex; Godoy, Guilherme; Lepor, Herbert
OBJECTIVES: To examine the pathologic findings and biochemical recurrence rates for a consecutive cohort of candidates for active surveillance who underwent radical prostatectomy. The role of active surveillance for the treatment of low-risk prostate cancer is highly controversial. METHODS: Between October 2000 and February 2008, a single surgeon performed 1565 open radical retropubic prostatectomies for clinically localized prostate cancer. Cases were selected for extraction if they fulfilled 1 of 2 published criteria for active surveillance in our prospective longitudinal outcomes database. A retrospective review of the prospectively collected database was executed to elucidate the outcomes of candidates for active surveillance who underwent radical retropubic prostatectomy. Gleason score, pathologic stage, and surgical margins were prospectively captured in our database. The 5-year, biochemical-free survival rates were estimated using Kaplan-Meier analysis plots. RESULTS: Overall, 45.9%-47.2% of cases were pathologically upgraded to a Gleason score >/= 7. Moreover, 12.3%-13.1% of cases were found to have a primary Gleason pattern of 4 or 5. Extracapsular extension (pT3a disease) was observed in 7.8%-10.9% of cases. A total of 28.8%-32.2% of cases had an estimated percentage of cancer volume in the surgical specimen exceeding 20%. The 5-year biochemical-free survival was estimated to be 83.2%-92.9%. CONCLUSIONS: Our pathologic findings and risk of biochemical recurrence after open radical prostatectomy questions the wisdom of active surveillance in men with low-risk disease who have 'long' life expectancies
PMID: 20494409
ISSN: 1527-9995
CID: 112424
The preoperative use of erythropoietin stimulating proteins prior to radical prostatectomy is not associated with increased cardiovascular or thromboembolic morbidity or mortality
Lepor, Herbert; Lipkin, Michael; Slova, Denisa
OBJECTIVES: To critically examine the cardiovascular and thromboembolic risks associated with erythropoietin stimulating proteins (ESPs) in men with normal hemoglobin levels undergoing open radical retropubic prostatectomy. METHODS: Between October 1, 2000, through December 31, 2006, a total of 1308 men underwent open radial retropubic prostatectomy by a single surgeon. Of these men, 1095 received preoperative ESPs. Hematocrit levels measured at baseline, immediately before anesthesia induction and at hospital discharge, were prospectively entered into a database. Thromboembolic and cardiovascular complications were prospectively captured during the hospitalization and after surgery. RESULTS: The mean Delta preoperative hematocrit level was 5.9 g/dL. The pre-anesthesia induction hematocrit level was 49.2%. Hospital discharge hematocrit level was 33.6 g/dL. The overall risk of cardiovascular and thromboembolic complications in men receiving ESP were 0.55% and 0.45%, respectively. The risk of cardiovascular and thromboembolic complications were independent of the Delta in preoperative hematocrit or the absolute level of the pre-anesthesia induction hematocrit. CONCLUSIONS: ESPs represent a safe and effective preoperative blood management strategy for men undergoing open radical retropubic prostatectomy
PMID: 20513505
ISSN: 1527-9995
CID: 112482
Oncologic, Functional, and Cost Analysis of Open, Laparoscopic, and Robotic Radical Prostatectomy [Meeting Abstract]
Djavan, B; Eckersberger, E; Finkelstein, J; Sadri, H; Farr, A; Apolikhin, O; Lepor, H
Context: Although open radical retropubic prostatectomy (ORRP) remains the gold standard, the past years have seen a rise in both laparoscopic radical prostatectomy (LRP) and robot-assisted radical prostatectomy (RARP), and many patients seem to prefer the so-called minimally invasive procedures despite insufficient data demonstrating superiority over the established standard (ORRP). Objective: This article seeks to review the most recent data on a variety of aspects of the different techniques for performing prostatectomies, such as cost, oncologic outcomes, continence, quality of life, and marketing and propaganda as well as the learning curve for each. Evidence acquisition: A search of the most recent literature was performed using PubMed, and data from lectures and presentations given at international conferences were used. Evidence synthesis: The review showed that, overall, LRP and RARP outcomes have not proved superior to ORRP outcomes or resulted in anticipated benefits to patients. In addition, current data seem to suggest that results of any of the procedures depend more on the surgeon's ability than on the approach, with rates of blood loss, positive surgical margins, incontinence, and erectile dysfunction varying widely from surgeon to surgeon with all three techniques. The aggressive marketing associated with RARP has also led to significantly higher rates of dissatisfaction and regret in patients. Conclusions: Considering the evidence, ORRP remains the gold standard in radical prostatectomies. Moreover, although the differences among major outcomes are minor and associated with shorter lengths of stay, the costs associated with LRP and RARP are significantly higher than with ORRP. In the absence of solid scientific evidence, patient education, and counselling are crucial parts of the decision-making process, during which patients will opt for one treatment over another. (C) 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved
ISI:000276527200001
ISSN: 1569-9056
CID: 109137
Para-anastomotic haematoma volume predicts the presence of anastomotic extravasation after radical retropubic prostatectomy
O'Malley, Rebecca L; Telegrafi, Shpetim; Laze, Juliana; Lepor, Herbert
Study Type - Therapy (case series) Level of Evidence 4 OBJECTIVE To determine the mechanism for delayed healing of the urinary anastomosis after radical retropubic prostatectomy (RRP). PATIENTS AND METHODS The volumes of the para-anastomotic haematoma (PHV) and anastomotic extravasation were measured by ultrasonography in 95 men after RRP. The performance characteristics of PHV for predicting urinary extravasation were ascertained and compared with that of postoperative blood loss, measured as the difference between the haematocrit immediately after RRP and that at discharge. RESULTS The sensitivity and specificity of PHV for predicting urinary extravasation at a threshold of 37 mL was 100% and 96%, respectively. PHV was superior to postoperative blood loss in predicting anastomotic extravasation, as shown by an area under the receiver operating curve of 0.99 vs 0.91, respectively. CONCLUSIONS Our findings provide compelling evidence that delayed healing of the anastomosis after RRP is due to distraction forces secondary to a pelvic haematoma. The accuracy of PHV as a predictor of anastomotic extravasation suggests that this measurement might replace cystography for assessing anastomotic integrity after RRP
PMID: 19583719
ISSN: 1464-4096
CID: 106590
Effects of the selective alpha 1a-adrenoceptor antagonist silodosin on ECGs of healthy men in a randomized, double-blind, placebo- and moxifloxacin-controlled study
Morganroth, J; Lepor, H; Hill, L A; Volinn, W; Hoel, G
In order to determine the effects of therapeutic and supratherapeutic doses of silodosin on QT interval, healthy men (N = 186; aged 18-45 years) were randomized to receive silodosin (8 or 24 mg) or placebo for 5 days or moxifloxacin 400 mg (positive control, known to prolong QT) once on day 5. At baseline and on day 5, five ECGs were recorded 0.25 h before dosing and 1, 1.5, 2, 3, 4, 6, 8, 10, and 23.5 h after dosing. Adjusted mean differences (analysis of covariance) between silodosin and placebo in the change in individual heart rate-corrected QTc (QTcI) from baseline to day 5 were <5 ms at all times (all 90% confidence interval (CI) upper limits <10 ms). The QTcI difference for moxifloxacin compared with placebo often exceeded 5 ms, establishing assay sensitivity. For silodosin, no statistically or clinically significant correlation was seen between plasma concentration and QTcI, and no clinically important effects on heart rate, PR segment, QRS complex, or morphologic ECG data were observed
PMID: 20220748
ISSN: 1532-6535
CID: 134362
Impact of ultrahigh baseline PSA levels on biochemical and clinical outcomes in two Radiation Therapy Oncology Group (RTOG) prostate clinical trials [Meeting Abstract]
Rodrigues, G.; Bae, K.; Roach, M.; Lawton, C.; Donnelly, B.; Grignon, D.; Hanks, G.; Porter, A.; Lepor, H.; Sandler, H.
ISI:000276606603522
ISSN: 0732-183x
CID: 3159722
TRANSPERINEAL UILTRASONOGRAPHY: POTENTIAL FOR A NEW STANDARD IN ASSESSING ANASTOMOTIC LEAK POST-RADICAL PROSTATECTOMY [Meeting Abstract]
Telegrafi, Shpetim; Ito, Timothy; Kozirovsky, Mariana; Laze, Juliana; Lepor, Herbert
ISI:000264448502530
ISSN: 0022-5347
CID: 2166042
A PROSPECTIVE CONCURRENT STUDY OF THE LONGITUDINAL EFFECTS ON STRETCHED PENILE LENGTH AFTER ROBOTIC AND OPEN PROSTATECTOMY FROM AN INTRAURETHRAL ALPROSTADIL VS SILDENAFIL PENILE REHABILITATION STUDY [Meeting Abstract]
Engel, Jason D; Wagner, Kristofer R; Bytyci, Artrit; Goodwin, Brianne; Hyams, Elias S; Lepor, Herbert; Taneja, Samir S; McCullough, Andrew R
ISI:000264448500457
ISSN: 0022-5347
CID: 1872462