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Objective: To assess Duke's experience on the utility of transperineal template mapping biopsy (TTMB) for re-evaluating patients with persistently elevated prostate-specific antigen after prior negative biopsy, with pre-existing prostate cancer (PCa) already on active surveillance (AS), or considering focal therapy (FT)., Methods: We retrospectively reviewed Duke patients undergoing TTMB. Functional outcomes were evaluated using International Index of Erectile Function-5 (IIEF-5) and International Prostate Symptom Score (IPSS). Complications within 30 days were recorded. Nonparametric statistical analyses compared functional measures from baseline to 2 and 6 weeks post-TTMB., Results: From 8/2009 to 1/2021, 218 patients underwent TTMB, with 57-month median follow-up. Complication rate was 17.4%, with the majority Clavien I. Overall PCa detection was 72.9%, with clinically significant PCa in 53.2%; for those without prior PCa diagnosis (n = 117), overall detection was 64.1% with clinically significant PCa in 49.5%. Of those on AS at TTMB (n = 86), 36 (41.8%) had Gleason upgrading. TTMB changed management for 59 (68.6%) patients, with 38 (44.2%) proceeding to whole-gland therapy and 21 (24.4%) electing FT. Regarding functional outcomes, IPSS were insignificantly different from baseline at 6 weeks (P = NS). Overall functional score impacts were minimal across subgroups; in groups with significant declines in IIEF-5, median score drops were ≤1 point and caused minimal/no movement in IIEF-5 scoring category., Conclusion: In this cohort, TTMB offered enhanced cancer detection with overall minimal impact to functional outcomes. We conclude from this comprehensive assessment that TTMB provides value to rule out PCa, prevent overtreatment of those that can remain on AS, evaluate FT candidacy, and identify those needing whole-gland management., Competing Interests: DECLARATION OF COMPETING INTEREST None., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To assess how the validated Prostate Health Index (PHI) risk stratifications perform with African American (AA) men and establish a threshold PHI value to potentially rule out the need for prostate biopsy., Materials and Methods: AA men meeting FDA-specified indications for PHI testing (>50 years old, PSA 4-10 and negative DRE) who underwent subsequent biopsy were included. Rates of clinically significant prostate cancer (csPCa, as defined by Gleason score ≥7) across accepted PHI stratifications were recorded. Receiver operator curve (ROC) analysis was undertaken to assess PHI performance to predict csPCa. A phi cutoff providing 90% sensitivity was identified. Among AA men with PSA 4-10 ng/mL, the proportion of men who proceeded to biopsy upon physician recommendation was determined., Results: Two hundred nine patients met primary criteria; 91 (43.5%) of which had csPCA. The area under the curve for PHI predicting csPCa was 0.68 (95% CI: 0.61-0.75). Using a phi threshold of <23.0 to avoid biopsy provided 98.9% sensitivity, 9.3% specificity, and would have avoided 4.7% of biopsies. The proportion of those who proceeded to biopsy upon physician recommendation was 81.8%., Conclusions: PHI demonstrated limited performance in our cohort, with current stratifications featuring misleadingly low cancer detection rates for these men. Furthermore, PHI had limited use to avoid prostate biopsy, as the proposed threshold of 23.0 only allowed 4.7% of men to avoid biopsy. Further work is needed to assess and optimize PHI usage in AA men; nonetheless, it may still have use in increasing compliance with biopsy recommendation., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: To assess the comparative safety and effectiveness of 2 prostate cancer treatment ablation modalities: irreversible electroporation (IRE) and high-intensity focused ultrasound (HIFU).  METHODS: Two systematic literature reviews (SLRs) and meta-analyses (MAs) on IRE and HIFU were conducted in accordance with PRISMA guidelines. Searches were conducted in PubMed and EMBASE. Independent reviewers assessed literature eligibility and abstracted safety and effectiveness data. Oncological, safety, functional, and quality of life (QOL) outcomes were examined for each technology. MAs were conducted where data quality and availability allowed, using normal methods and a random/mixed effects model, and quality assessments performed., Results: Fifty-five publications (n = 22 IRE; n = 33 HIFU) were included in the SLRs, and MAs were conducted on negative in-field post-procedure biopsy, prostate-specific antigen (PSA) level reduction, potency, urinary continence, and AE rate outcomes. MAs revealed that IRE patients had lower mean percent PSA level reductions, higher mean rates of in-field negative post-treatment biopsy, and higher rates of potency maintenance than HIFU patients. Most adverse events (AEs) reported were comparable and minor (Grades I, II), with urinary tract infection, dysuria, hematuria, and incontinence or urgency most frequently reported. The proportion of patients experiencing a severe AE (≥Grade III) ranged from 0 to 8% after IRE and HIFU. Both modalities were associated with positive functional outcomes as well as maintenance of QOL after treatment., Conclusions: Both IRE and HIFU were found to produce favorable effectiveness outcomes and have low complication rates while minimally impacting patient urinary and erectile function and maintaining overall QOL. These real-world findings can help guide clinical decision making and improve disease management for patients with prostate cancer., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To assess the complications and erectile and urinary functional outcomes of transperineal template mapping biopsy (TTMB) of the prostate., Methods: We retrospectively reviewed the records of 84 patients undergoing TTMB at our institution and recorded complications and functional outcomes. Erectile and urinary functions were measured at baseline, 2 weeks, and 6 ± 2 weeks after TTMB using the International Index of Erectile Function short version (IIEF-5) and International Prostate Symptom Score questionnaires. Erectile and urinary function parameters were compared between baseline and 2 and 6 weeks after TTMB in a paired fashion. A subanalysis of erectile function was performed in preoperatively potent men (IIEF-5 >17)., Results: Sixteen patients (19%) experienced complications. The most common events were transient urinary retention (6%), prostatitis (4%) and local events, including perineal hematoma, bruising, or perineal pain (5%). One patient with hematuria required intervention. IIEF-5 scores at baseline, 2 weeks, and 6 weeks were 20 (interquartile range [IQR], 16-23), 18 (IQR, 12-22), and 18 (IQR, 12-22), respectively (P = .096 and P = .034). Among preoperatively potent men, IIEF-5 scores at baseline, 2 weeks, and 6 weeks were 22 (IQR, 20-24), 21 (IQR, 18-24), and 22 (IQR, 18-24), respectively (P = .011 and P = .018). International Prostate Symptom Scores were 6 (IQR, 3.5-11) at baseline, rose to 10 (IQR, 4.8-15) at 2 weeks (P = .012), and returned to 7 (IQR, 3.5-13) at 6 weeks (P = .628)., Conclusion: TTMB has a favorable morbidity profile, with mostly mild and transient complications. Urinary retention occurred in 6%, and only 1 patient required intervention with bladder irrigation. Despite a statistically significant decline in erectile function from baseline, the median change in IIEF-5 score was 1 point. Urinary symptoms worsened initially but returned to baseline within 6 weeks., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objectives: To evaluate changes in urinary function after cryoablation for clinically localized prostate cancer and to investigate risk factors that predict changes in urinary function after surgery., Methods: Among the patients who underwent primary or salvage cryoablation between January 2002 and May 2008, 74 patients (50 primary and 24 salvage) with both a preoperative and postoperative urinary function domain score and uroflowmetry were included in this study. The mean age was 66.8 ± 7.5 years and the mean follow-up period was 42.5 ± 20.3 months. The changes in postoperative urinary function were evaluated on the basis of several categorized groups, including surgical method, preoperative urinary symptoms, and prostate volume., Results: Of 74 patients, 2 (2.7%) presented with mild stress incontinence after cryoablation. No patient presented with persistent urinary retention or urethral fistula. When comparing postoperative International Prostate Symptom Score (IPSS) and bother index scores with preoperative scores, it was found that on average IPSS and bother index recovered 12 and 18 months after cryoablation, respectively, and continued to improve after recovery. Only salvage cryoablation correlated with deteriorating urinary function in a logistic regression model (P = .032). However, it was noted that the patients with preoperative moderate to severe urinary symptoms and larger prostate volume showed improvement of urinary function after cryoablation. No associations were found between worsened urinary function and prostate volume, comorbidities (hypertension, obesity, and diabetes), or sexual function., Conclusions: Cryoablation is a minimally invasive surgery for localized prostate cancer. This study is the first to demonstrate the ability of cryoablation in terms of maintaining and potentially improving urinary function using validated instruments and uroflowmetry assessments., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Objectives: To evaluate the relationship between initial prostate-specific antigen (PSA) and prostate cancer (PCa) risk in elderly African American (AA) and Caucasian American (CA) men., Methods: A total of 408 AA and 1720 CA men whose initial PSA measurement was performed between 75 and 80 years of age were retrieved from Duke Prostate Center database. Patients were stratified by race and initial PSA value. The relative risk (RR) of PCa detection was estimated. The rates of high risk PCa, and death from PCa stratified by initial PSA groups were compared using the chi-square test., Results: The age-adjusted RR of PCa detection in CA men with PSA 3.0-5.9 ng/mL was 1.9-fold higher when compared with that of men with PSA 0.0-2.9 ng/mL (P < .001), but it did not change significantly in AA men (P = .270). PSA 6.0-9.9 ng/mL was associated with age-adjusted RR of PCa 9.3-fold in AA men and 4.1-fold in CA men (both P values < .001). A low rate of high-risk PCa and death from PCa was indicated with PSA < 6.0 ng/mL and < 3.0 ng/mL and follow-up of a maximum of 19.2 years and 17.6 years, respectively, in AA and CA men., Conclusions: AA men with initial PSA < 6.0 ng/mL and CA men with initial PSA < 3.0 ng/mL between 75 and 80 years of age are unlikely to be diagnosed with high risk PCa or death from PCa. It may be safe to discontinue PSA screening in these men., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Objectives: To evaluate the US Preventative Services Task Force (USPSTF) recommendation to discontinue prostate-specific antigen (PSA) screening at age 75., Methods: Public survey: A cohort of 340 patients was surveyed at our PSA screening clinic and stratified by awareness of the recommendation and education level. Age (< 75, >or= 75), race, health insurance status, knowledge of prostate cancer, and opinion on screening discontinuation at age 75 was evaluated between groups. Disease risk and survival analysis: A cohort of 4196 men who underwent radical prostatectomy between 1988 and 2008 was stratified into age groups: < 65, 65-74, and >or= 75. Associations between clinicopathologic variables, disease risk, and survival were compared between age groups using univariate and multivariate analysis., Results: Approximately 78% of men surveyed disagreed with the USPSTF recommendation. The number of men who disagreed was not significantly different between awareness groups (P = .962). Awareness of new screening guidelines showed a significant difference (P = .006) between education groups. Age >or= 75 years was predictive of high-risk disease based on D'Amico's criteria (odds ratio = 2.72, P = .003). Kaplan-Meier and Cox regression analyses showed an association of men aged >or= 75 years with higher rate of PSA recurrence, distant metastasis, and disease specific death compared with the age groups of < 65 and 65-74 (P <.05)., Conclusions: Men presenting to our PSA screening clinic disagreed with discontinuation of screening at age 75. Men aged >or= 75 years had higher risk disease and poorer survival. The USPSTF recommendation was supported neither by public opinion nor disease risk and survival results., (Copyright 2010. Published by Elsevier Inc.)

Objective: To analyze factors that may contribute to local relapse after laparoscopic cryoablation (LCA) of renal tumors. LCA has gained popularity in the treatment of small renal tumors, but local tumor control remains a concern., Methods: We analyzed 163 patients who underwent LCA between 2001 and 2008 either at Allegheny General Hospital or Duke University Medical Center, with at least 6 months of follow-up. Demographics, perioperative variables, tumor characteristics (size, pattern of growth, and biopsy results), and follow-up were recorded. Growth pattern was categorized as exophytic, mesophytic, or endophytic. Regression analyses were performed to evaluate risk factors for local relapse after LCA., Results: Median patient age was 66 (range, 33-90) years, with men comprising 60.1% of the cohort. Median tumor size was 2.4 cm (range, 0.5-5.0). Pathology was as follows: renal cell carcinoma in 118 (72.4%), other malignancies in 2 (1.2%), and no malignancy in 43 (26.4%) patients. A single lesion was treated in 95.1% patients and multiple tumors in 4.9%. Endophytic growth pattern was present in 22.8% patients. We observed 7 (4.3%) local recurrences over a median follow-up of 20 months (range, 6-79). Median time to recurrence was 15 months (range, 6-48). On proportional hazards regression, tumor size and endophytic growth pattern were significantly associated with local recurrence (P = .003 and .028; odds ratios [OR] = 4.1 and 11.4, respectively)., Conclusions: LCA demonstrated good tumor control over a 5-year follow-up, with an acceptable recurrence rate. Larger tumors and those with endophytic growth pattern may be at increased risk of relapse after LCA., (2010 Elsevier Inc. All rights reserved.)

Objectives: To compare the effects of tumor volume (TV), tumor percentage involvement (TPI), and prostate volume (PV) on prostate-specific antigen (PSA) recurrence (PSAR) after radical prostatectomy (RP)., Methods: A cohort of 3528 patients receiving RP between 1988 and 2008 was retrieved from the Duke Prostate Center. Patients were stratified by TV (< 3, 3-6, > 6 cm(3)), TPI (< 10%, 10%-20%, > 20%), and PV (< 35, 35-45, > 45 cm(3)) and their effects on PSAR evaluated using Kaplan-Meier analysis. Clinicopathologic variables included in univariate analysis were age at surgery, race, year of surgery, PSA, pathologic Gleason score, pathologic tumor stage, margin status, extracapsular extension, and seminal vesicle invasion. The effects of TV, TPI, and PV (as continuous and categorical variables) on PSAR were compared using Cox analysis., Results: TPI, TV, and PV were predictive of PSAR (P <.05) in Kaplan-Meier analysis. In multivariate analysis as continuous variables, TPI and PV were predictive of PSAR (hazard ratio [HR] = 1.16 and HR = 0.65, P <.05). As categorical variables, TPI > 20% and PV 10-35 cm(3) were predictive of PSAR (HR = 1.45 and OR = 1.25, P <.05). TV was not predictive of PSAR in either analysis. Pathologic Gleason score > or = 7, PSA, positive margins, seminal vesicle invasion, and tumor stage T3/T4 were found to be predictors of PSAR (P <.05)., Conclusions: TV, TPI, and PV were predictive of PSAR in univariate analysis, but in multivariate analysis, only TPI and PV were predictive of PSAR. TPI and PV should be considered when evaluating, assessing, and counseling patients regarding PSAR risk., (2010 Elsevier Inc. All rights reserved.)

Objectives: To compare Gleason scores (GS) originally assigned in the mid 1990s with the current pathologic evaluation of the same prostatectomy slides, and to assess the GS migration effect on outcome in patients undergoing surgical treatment of prostate cancer., Methods: We reviewed medical charts of consecutive patients who underwent a radical prostatectomy for T2-T3 prostate cancer at our Medical Center between 1995 and 1997. Prostate specimen slides of 204 patients were reviewed and GS was reassigned in a blinded fashion by a single uropathologist in 2008. GS distributions were compared, and original and re-evaluated GS were assessed for predictive ability in survival regression models., Results: GS distribution differed significantly between the mid 1990s and the current evaluation (P < .001), with the average reevaluated GS higher than the initial one (6.14 vs 6.39, P < .001). The GS was upgraded in 63 cases (30.9%) and downgraded in 25 (12.3%) at reevaluation. The initial GS was predictive (P = .002) of prostate-specific antigen recurrence (PSAR), whereas the newly assigned GS was not (P = .393). However, grouping reassigned GS into risk groups (low < 7, moderate = 7 and high > 7) yielded a better PSAR definition. Survival curves of initial GS could not distinguish between moderate- and high-risk groups, although reassigned GS curves showed statistically significant differences between all risk groups., Conclusions: These results suggest that interpretation of pathologists played a significant role in the GS shift and propose that the contemporary GS remains a useful prognostic factor of PSAR when stratified in risk categories, although the single GS value may not be as important.

Objectives: To identify factors that predict delayed (> 5 years) prostate-specific antigen recurrence (PSAR) after radical prostatectomy (RP) and to analyze the associated clinical outcomes., Methods: A cohort of 4561 men who underwent RP between 1988 and 2008 was retrieved from the Duke University Prostate Center database. Among them, 1207 (26.5%) had PSAR and were included in this study. The cohort was then divided into 2 groups; PSAR before 5 years (early PSAR) and PSAR after 5 years (delayed PSAR), and Kaplan Meier analysis was performed. Univariate and logistic regression analysis was carried out to determine significant predictors of delayed PSAR, using factors such as race, age, body mass index, PSA, surgical margin status, pathologic Gleason sum, pathologic tumor stage, and prostate weight., Results: There was a marginal difference between the early and delayed PSAR groups with regard to metastasis-free survival (P = .062). A significant difference in disease-specific survival was found between the 2 groups (P = .025). Patients with pathologic Gleason sums < 7 were more likely to have delayed PSAR as compared to those with pathologic Gleason sums > 7 (OR = 2.38). Patients with a PSA < 10 ng/mL were more likely to have delayed PSAR in comparison to those with PSA > 20 ng/mL (OR = 2.38)., Conclusions: Approximately 90% of PSAR occurred within 5 years after RP. Lower pathologic Gleason sums and lower PSA at diagnosis were associated with delayed PSAR. Patients with delayed PSAR have a disease-specific survival advantage as compared to men with early PSAR.

Objectives: To assess the discrepancies between diagnostic and pathologic Gleason sums and the predictive role of age and prostate-specific antigen (PSA) level on Gleason sum discrepancies., Methods: A total of 2963 patients receiving radical prostatectomy at Duke University from 1988 to 2006 were divided into two groups according to year of diagnosis: 1988 to 1999 and 2000 to 2006. The Gleason sum discrepancies were evaluated in the above groups. The predictive roles of diagnostic age (less than 50, 50 to 60, 60.1 to 70, and greater than 70 years), PSA level (less than 10, 10 to 20, and greater than 20 ng/mL), race, body mass index, and prostate weight on the discrepancies were analyzed., Results: Overall, 55.8% of diagnostic Gleason sums differed from those on final surgical pathology (58.6% in the 1988 to 1999 and 49.3% in the 2000 to 2006 groups). Diagnostic Gleason sums were undergraded in 41.2% of cases and overgraded in 12.8% of cases. Men older than 60 years were more likely to have their diagnostic Gleason sums undergraded than men younger than 50 (odds ratio in age groups less than 50, 50 to 60, 60.1 to 70, and greater than 70 years: 1.00, 2.30, 4.03, and 3.96, respectively). Biopsy Gleason sums in men with a high PSA level were more likely to be undergraded compared with the PSA group less than 10 ng/mL (odds ratio in PSA groups less than 10, 10 to 20, and greater than 20 ng/mL: 1.00, 2.11, and 3.64, respectively)., Conclusions: Significant discrepancies between diagnostic and pathologic Gleason sums remain in recent years. The rate of diagnostic Gleason sum undergrading was 3.2-fold that of overgrading. Advanced age and high PSA level were predictive of diagnostic Gleason sum undergrading, and caution should be exercised when recommending active surveillance in older men.

Laparoscopic cryoablation is a minimally invasive treatment that is currently used to treat small renal tumors. Despite its growing use and promising outcomes, complications can occur. We report the first clinical case of urothelial sloughing with obstruction after cryoablation of a small renal tumor in a solitary kidney.

Objectives: We evaluated the lower threshold of prostate-specific antigen (PSA) and prostate-specific antigen velocity (PSAV) in a population of men over 70 years of age., Methods: Between January 1988 and December 2005, 4038 men over 70 years of age including 605 African-American (AA) men and 3433 non-AA men from the Duke Prostate Center Outcomes database had determination of serum PSA and PSAV. We used receiver operating characteristic (ROC) curves to display the data graphically., Results: The median age for all men on the study was 75 years. The area under the curve (AUC) for PSA in AA men and non-AA men was 0.84 and 0.76, respectively. For PSAV the AUC was 0.71 versus 0.54, respectively. The largest relative sensitivity and specificity in AA men was achieved at the established PSA cut-point of 4.0 ng/mL: 85% and 71%, respectively. The best cut-point in non-AA men was 3.4 ng/mL, which resulted in a sensitivity and specificity of 72% and 73%, respectively. The AUC of ROC curves within various age subgroups tends to be stable regardless of how the ages are grouped. In a multivariate logistic regression model age, PSA and PSAV were significant predictors of cancer status in the AA subset. Age and PSA were significant predictors in the non-AA subset., Conclusions: The AUC of ROC curves within various age subgroups tends to be stable; therefore, we are led to believe that a PSA or PSAV cutoff for safely commending discontinuation of PCa screening is not apparent from these data.

Objectives: To evaluate biologic behaviors of unilateral cancers compared with bilateral cancers on prostate-specific antigen (PSA) recurrence after radical prostatectomy., Methods: Analysis included demographic, clinical, and pathologic parameters of 1184 men who underwent RP for clinically localized prostate cancer at our institution between 2002 and 2006. Final pathologic assessment was performed with particular attention to laterality and percentage of tumor involvement, along with other routine parameters. On the basis of percentage of tumor involvement, all cancer foci were ranked as 5% or less, 5.01% to 10%, 10.01% to 15%, or greater than 15%. Statistical analysis was performed with univariate and multivariate methods., Results: Overall, 19.2% of 1184 patients had completely unilateral cancers. Prostate-specific antigen recurrence was revealed in 164 of 1184 patients (13.9%) at a mean (+/- standard deviation) follow-up of 2.7 +/- 2.4 years. Among men who had recurrence, 26 of 227 (11.5%) had unilateral tumors and 138 of 957 (14.4%) had bilateral disease (P = 0.25). The most common characteristics associated with PSA recurrence of unilateral tumors in the Cox model were diagnostic PSA level, prostate weight, and pathologic Gleason score (P <0.05)., Conclusions: Unilateral or bilateral prostate cancer did not predict PSA recurrence in men receiving radical prostatectomy. In contrast, baseline PSA level and pathologic Gleason score strongly predicted PSA recurrence.

Objectives: Percutaneous perineal cryoablation of the prostate is a promising technique in the treatment armamentarium for clinically localized prostate carcinoma. We report our initial experience using a transrectal ultrasound-guided, third-generation, argon/helium cryosurgical system., Methods: From January 2002 to July 2005, 50 men underwent primary cryosurgery for clinically localized prostate carcinoma. The median patient age was 68 years (range 50 to 83), and the median follow-up period was 18 months (range 3 to 43). According to the D'Amico risk stratification system, 36 patients (72%) had low-risk, 9 (18%) had intermediate-risk, and 5 (10%) had high-risk prostate cancer. All patients underwent a dual freeze-thaw cycle using third-generation cryotechnology with ultrathin 17-gauge cryoneedles., Results: The prostate-specific antigen (PSA) level for all patients at the last follow-up visit was less than 0.5 ng/mL in 45 patients (90%) and 0.5 ng/mL or more in 5 (10%). Two patients had persistent prostate cancer confirmed by prostate biopsy and were treated with salvage cryotherapy or external beam radiotherapy. Three other patients had an elevated PSA level after cryotherapy despite negative posttreatment biopsies and a metastatic evaluation. Of these 3 patients, 2 had their postcryotherapy PSA level normalize, and 1 patient, with intermediate-risk disease preoperatively, had a consistent increase in PSA up to 1.2 ng/mL. The overall survival rate was 100%., Conclusions: Cryoablation of the prostate is a feasible and safe treatment option in patients with organ-confined prostate cancer. Additional studies with longer follow-up are necessary to determine the sustained efficacy of this procedure.

Percutaneous radiofrequency ablation is a minimally invasive treatment that is currently used to treat renal tumors. Despite its minimally invasive nature, potential serious complications can occur. We report the second case of ureteropelvic junction obstruction after radiofrequency ablation that resulted in nephrectomy. The use of radiofrequency ablation should be considered with caution, particularly when tumors are centrally located or abut the renal pelvis. Additional data are needed to better define the indications and contraindications to minimally invasive ablative technologies when used in the clinical setting.

Objectives: To describe 6 cases of rectourethral fistula in patients treated with brachytherapy plus external beam radiotherapy for localized prostate cancer and subsequent rectal biopsies or rectal surgery., Methods: A retrospective chart review was undertaken of patients with prostate cancer treated with brachytherapy who presented to our institution with the diagnosis of rectourethral fistula from February 1999 to June 2002. Potential contributing factors, including patient age, cancer grade and stage, cancer treatment, rectal procedure, and time to the complication, were evaluated. Potential approaches to rectourethral fistula treatment and their outcomes are reported., Results: The mean patient age was 63.8 years. All 6 men underwent combination prostate brachytherapy and external beam radiotherapy with subsequent rectal biopsy/hemorrhoidectomy. All 6 patients developed a rectourethral fistula, with an average time between the end of radiotherapy and fistula development of 22.6 months. Four patients underwent hyperbaric oxygen therapy, which failed. Three patients underwent fecal diversion with gracilis interposition flaps, and two underwent pelvic exenteration., Conclusions: The results of our study have shown that rectourethral fistula development is a serious complication of combination radiotherapy, with definitive repair requiring major intraabdominal surgery. Biopsy of rectal ulcers in the clinical setting of combined radiotherapy should not be performed. In addition, elective rectal surgery should not be performed on irradiated tissue. In our series, hyperbaric oxygen therapy and conservative treatment did not obviate the need for definitive surgical management of the rectourethral fistula.

Objectives: To evaluate the financial implications of how the costs of new minimally invasive surgery such as laparoscopic robotic prostatectomy (LRP) and cryosurgical ablation of the prostate (CAP) technologies compare with those of conventional surgery., Methods: From January 2002 to July 2005, 452 consecutive patients underwent surgical treatment for clinically localized (Stage T1-T2) prostate cancer. The distribution of patients among the surgical procedures was as follows: group 1, radical retropubic prostatectomy (RRP) (n = 197); group 2, radical perineal prostatectomy (RPP) (n = 60); group 3, LRP (n = 137); and group 4, CAP (n = 58). The total direct hospital costs and grand total hospital costs were analyzed for each type of surgery., Results: The mean length of stay in the CAP group was significantly lower (0.16 +/- 0.14 days) than that for RRP (2.79 +/- 1.46 days), RPP (2.87 +/- 1.43 days), and LRP (2.15 +/- 1.48 days; P <0.0005). The direct surgical costs were less for the RRP (2471 dollars +/- 636 dollars) and RPP (2788 dollars +/- 762 dollars) groups than for the technology-dependent procedures: LRP (3441 dollars +/- 545 dollars) and CAP (5702 dollars +/- 1606 dollars; P <0.0005). The total hospital cost differences, including pathologic assessment costs, were less for LRP (10,047 dollars +/- 107 dollars, median 9343 dollars) and CAP (9195 dollars +/- 1511 dollars, median 8796 dollars) than for RRP (10,704 dollars +/- 3468 dollars, median 9724 dollars) or RPP (10,536 dollars +/- 3088 dollars, median 9251 dollars), with significant differences (P <0.05) between the minimally invasive technique and open surgery groups., Conclusions: In our study, despite the relatively increased surgical expense of CAP compared with conventional surgical prostatectomy (RRP or RPP) and LRP, the overall direct costs were offset by the significantly lower nonoperative hospital costs. The cost advantages associated with CAP included a shorter length of stay in the hospital and the absence of pathologic costs and the need for blood transfusion.

Patients with metachronous bilateral renal cell carcinoma pose a significant challenge given the high mortality of renal cell carcinoma and the poor quality of life should dialysis become necessary. In addition, patients may be subject to morbidity due to potential multiple treatments of the multifocal renal tumors. We present the case of a 71-year-old woman with multifocal, bilateral clear cell carcinoma who maintained a minimal change in serum creatinine after undergoing unilateral radical nephrectomy, subsequent percutaneous radiofrequency ablation, percutaneous cryoablation, laparoscopic cryoablation, and open partial nephrectomy for recurrent renal cell carcinoma in a solitary kidney.

Obstruction of the urinary collecting system in pregnant women can present a unique challenge to the urologist. Although ureteral obstruction due to stone disease is well-documented and ureteral obstruction is a well-known and defined cause of acute renal failure, obstruction from extrinsic compression is a less-understood phenomenon. We report a case of ureteral obstruction from hyperplastic ovaries in a pregnant woman receiving hormonal therapy that was managed initially with ureteral stenting.

Objectives: To evaluate our experience with percutaneous radiofrequency ablation (pRFA) to determine common characteristics of patients with complications, to elucidate possible relative contraindications to therapy., Methods: Medical records of all patients undergoing pRFA were reviewed for demographic data, medical and surgical history, indication, tumor characteristics, and treatment information (complications and management). The group of patients with complications was analyzed for common characteristics., Results: From January 2000 to September 2003, 24 patients (mean age 61 years, 5:1 male/female) with 32 renal tumors were treated with pRFA. Indications for pRFA included prior renal surgery and/or chronic renal insufficiency, significant medical disease, patient choice, von Hippel-Lindau disease, and treatment of a metastasis. Average pretreatment tumor size was 2.4 cm (range 0.5-8.6 cm). Of the 5 patients experiencing complications from pRFA treatment, 2 developed perinephric hematomas, 1 had a persistent urinoma and proximal ureteral stricture, and 2 had colonic injuries. Among patients with complications, 3 of 5 had undergone prior partial nephrectomy on the pRFA-treated kidney. Two of four patients treated for multiple tumors and 57% of patients (4 of 7) with anteriorly located tumors experienced complications., Conclusions: Early experience with pRFA for renal tumor seems promising, but patient selection criteria are evolving. On the basis of our limited experience, we recommend caution when using renal pRFA in patients with prior partial nephrectomy, multiple tumors treated in the same setting, and tumors located anteriorly or centrally. Further clinical experience will help establish guidelines for the use of this powerful technology in the management of renal tumors.

Objectives: To evaluate the efficacy and safety of zoledronic acid in preventing bone loss in patients with hormone-sensitive prostate cancer and bone metastases who were receiving androgen deprivation therapy., Methods: Patients received zoledronic acid 4 mg as a 15-minute infusion every 3 weeks for 1 year. Bone mineral density of the lumbar spine (L2 to L4) and total hip was measured by dual-energy x-ray absorptiometry at baseline and 12 months. Biochemical markers of bone turnover (N-telopeptide and bone alkaline phosphatase) and serum creatinine levels were evaluated at baseline and during the study. Skeletal-related events were assessed at each study visit., Results: Of the 221 enrolled patients, 202 and 221 patients were included in the efficacy and safety analyses, respectively. The mean increase in bone mineral density of the lumbar spine and total hip was 7.7% (P <0.001) and 3.6% (P <0.001), respectively. Decreases in N-telopeptide and bone alkaline phosphatase levels were significant and sustained. The median time to the first skeletal-related event was not reached; 11.9% of patients had a skeletal-related event. Arthralgia (20.4%), nausea (14%), fatigue (14%), and back pain (12.2%) were the most common adverse events. Adverse events due to renal function deterioration were infrequent. The mean maximal change in serum creatinine level from baseline was 0.3 mg/dL., Conclusions: Zoledronic acid administration for 1 year to patients with hormone-sensitive prostate cancer and bone metastases who were receiving androgen deprivation therapy was safe and prevented bone loss, as demonstrated by significant increases in bone mineral density and sustained suppression of biochemical markers of bone turnover.

Objectives: To characterize supplement use within a sample population of men diagnosed with prostate cancer., Methods: A census of men diagnosed with prostate cancer at Duke University Medical Center from 1997 to 2002 (n = 1402) was mailed a survey that ascertained data on health status, education, diet, exercise, smoking status, and information on supplement use. Differences between demographic and treatment subgroups were described and tested, as was change in supplement use after diagnosis., Results: Data from 805 respondents indicated that a majority (73%) used supplements, and 68% claimed that this information was shared with their cancer care provider. The most commonly reported supplements were multivitamins (56%), vitamin E (43%), vitamin C (33%), and calcium (26%). On average, 2.7 +/- 2.8 supplements per day were taken, and use increased significantly after diagnosis for most supplements. Use was significantly higher among men who were white (P = 0.043), were more highly educated (P = 0.002), exercise regularly (P = 0.020), and who consume five or more daily servings of fruits and vegetables (P = 0.040)., Conclusions: A high percentage of men with prostate cancer take supplements, especially those who are white, more educated, and who pursue healthful behaviors. Systematic means of capturing these data are necessary to begin to understand the potential impact of supplements on disease outcome, especially because no data exist to suggest that supplements are of any benefit after diagnosis.

Objectives: To determine the effect of prior benign prostate biopsies on the surgical and clinical outcomes of patients treated with radical perineal prostatectomy for prostate cancer., Methods: A total of 1369 patients with clinically localized prostate cancer underwent radical prostatectomy by a single surgeon between 1991 and 2001. A subset of 203 patients (14.9%), who had undergone at least one prior benign prostate biopsy for a rising prostate-specific antigen and/or abnormal digital rectal examination, constituted our study population. A total of 1115 patients with no prior biopsy represented our control group. After prostatectomy, patients were evaluated at 6-month intervals for biochemical evidence of recurrence, defined as a prostate-specific antigen level of 0.5 ng/mL or greater., Results: Patients with a prior benign biopsy had more favorable pathologic features with more organ-confined (74% versus 64%; P <0.001) and less margin-positive (9.8% versus 18%) disease. Only 24 patients (12%) in the study group (versus 20% in control group; P = 0.01) had eventual evidence of biochemical failure. Kaplan-Meier analyses suggested that patients with prior benign biopsies have improved biochemical disease-free survival, especially for those with more aggressive disease (Gleason sum 7 or greater; P <0.01). Overall, patients in the study group had lower probability (odds ratio 0.57, P <0.001) of biochemical failure compared with those in the control group., Conclusions: A prior benign prostate biopsy may be independently associated with more favorable surgical and biochemical outcomes after prostatectomy. Additional studies are needed to confirm these findings.

Objectives: Dietary factors may influence the prostate and have an impact on prostatic growth and disease. A small number of studies have suggested that flaxseed-supplemented, fat-restricted diets may thwart prostate cancer growth in both animals and humans. Unknown, however, is the potential effect of such a diet on benign prostatic epithelium., Methods: We undertook a pilot study to explore whether a flaxseed-supplemented, fat-restricted diet affects the proliferation rates in benign epithelium. We also explored the effects on circulating levels of prostate-specific antigen (PSA), total testosterone, and cholesterol. Fifteen men who were scheduled to undergo repeat prostate biopsy were instructed to follow a low-fat (less than 20% kcal), flaxseed-supplemented (30 g/day) diet and were provided with a supply of flaxseed to last throughout the 6-month intervention period. The PSA, total testosterone, and cholesterol levels were determined at baseline and at 6 months of follow-up. Reports from the original and repeat biopsies were compared, and proliferation (MIB-1) rates were quantified in the benign prostatic epithelium., Results: Statistically significant decreases in PSA (8.47 +/- 3.82 to 5.72 +/- 3.16 ng/mL; P = 0.0002) and cholesterol (241.1 +/- 30.8 to 213.3 +/- 51.2 mg/dL; P = 0.012) were observed. No statistically significant change was seen in total testosterone (434.5 +/- 143.6 to 428.3 +/- 92.5 ng/dL). Although 6-month repeat biopsies were not performed in 2 cases because of PSA normalization, of the 13 men who underwent repeat biopsy, the proliferation rates in the benign epithelium decreased significantly from 0.022 +/- 0.027 at baseline to 0.007 +/- 0.014 at 6 months of follow-up (P = 0.0168)., Conclusions: These pilot data suggest that a flaxseed-supplemented, fat-restricted diet may affect the biology of the prostate and associated biomarkers. A randomized controlled trial is needed to determine whether flaxseed supplementation, a low-fat diet, or a combination of the two regimens may be of use in controlling overall prostatic growth.

A 38-year-old man presented for evaluation of new-onset left testicular pain with swelling. Testicular ultrasound revealed multiple intraparenchymal hypoechoic areas in the inferior portion of the left testicle. The patient was treated with a radical inguinal orchiectomy. Pathologic evaluation revealed intratesticular vasculitis, with involvement of medium-sized arteries. This appears to be a rare case of isolated testicular vasculitis, in the absence of any systemic symptoms.

Objectives: The increased incidental detection of small (less than 4 cm) renal tumors has stimulated investigations of minimally invasive therapies. Radiofrequency energy is a relatively new and evolving technology that has been used for a variety of experimental and clinical applications. We evaluate the efficacy of hypertonic interstitial saline-augmented radiofrequency therapy to ablate a malignant VX-2 tumor implanted in a rabbit kidney, as measured by the completeness of tumor destruction and progression to metastasis., Methods: The VX-2 tumor was surgically implanted into the left lower pole parenchyma of 18 New Zealand white rabbit kidneys. Ten days after implantation, hypertonic interstitial saline-augmented radiofrequency ablation was performed (n = 12) using a radiofrequency therapy system (RFT, United States Surgical Corp.). A sham operation was performed on a control group (n = 6). Animals were humanely killed at 5, 10, and 15-day intervals, and the clinical response and effect of radiofrequency energy on the malignant renal tissue was assessed., Results: No postoperative complications were encountered. The mean size of the implanted VX-2 tumor was 1.87 cm2. Kidneys in the treated group exhibited marked destruction of tumor tissue. Histologic analysis revealed coagulative necrosis of both malignant and normal renal tissue in the treated group. Three rabbits (1 control, 2 treated) died of metastatic disease., Conclusions: Coagulative necrosis of renal parenchyma and tumor tissue was clearly demonstrated after radiofrequency ablation using the RFT system. The aggressive growth pattern of the VX-2 tumor often resulted in progression to metastatic disease while precluding complete tumor ablation. Hypertonic saline-augmented radiofrequency ablation is a promising new technology for the management of small, locally confined, renal tumors and has the potential for use with a minimally invasive approach.

Objectives: Dietary fat and fiber affect hormonal levels and may influence cancer progression. Flaxseed is a rich source of lignan and omega-3 fatty acids and may thwart prostate cancer. The potential effects of flaxseed may be enhanced with concomitant fat restriction. We undertook a pilot study to explore whether a flaxseed-supplemented, fat-restricted diet could affect the biomarkers of prostatic neoplasia., Methods: Twenty-five patients with prostate cancer who were awaiting prostatectomy were instructed on a low-fat (20% of kilocalories or less), flaxseed-supplemented (30 g/day) diet. The baseline and follow-up levels of prostate-specific antigen, testosterone, free androgen index, and total serum cholesterol were determined. The tumors of diet-treated patients were compared with those of historic cases (matched by age, race, prostate-specific antigen level at diagnosis, and biopsy Gleason sum) with respect to apoptosis (terminal deoxynucleotidyl transferase [TdT]-mediated dUTP-biotin nick end-labeling [TUNEL]) and proliferation (MIB-1)., Results: The average duration on the diet was 34 days (range 21 to 77), during which time significant decreases were observed in total serum cholesterol (201 +/- 39 mg/dL to 174 +/- 42 mg/dL), total testosterone (422 +/- 122 ng/dL to 360 +/- 128 ng/dL), and free androgen index (36.3% +/- 18.9% to 29.3% +/- 16.8%) (all P <0.05). The baseline and follow-up levels of prostate-specific antigen were 8.1 +/- 5.2 ng/mL and 8.5 +/- 7.7 ng/mL, respectively, for the entire sample (P = 0.58); however, among men with Gleason sums of 6 or less (n = 19), the PSA values were 7.1 +/- 3.9 ng/mL and 6.4 +/- 4.1 ng/mL (P = 0.10). The mean proliferation index was 7.4 +/- 7.8 for the historic controls versus 5.0 +/- 4.9 for the diet-treated patients (P = 0.05). The distribution of the apoptotic indexes differed significantly (P = 0.01) between groups, with most historic controls exhibiting TUNEL categorical scores of 0; diet-treated patients largely exhibited scores of 1. Both the proliferation rate and apoptosis were significantly associated with the number of days on the diet (P = 0.049 and P = 0.017, respectively)., Conclusions: These pilot data suggest that a flaxseed-supplemented, fat-restricted diet may affect prostate cancer biology and associated biomarkers. Further study is needed to determine the benefit of this dietary regimen as either a complementary or preventive therapy.

Objectives: Laparoscopy may be complicated by neuromuscular injuries, both to the patient and to the surgeon. We used a survey to estimate the incidence of these injuries during urologic laparoscopic surgery, to assess risk factors for these injuries, and to determine preventive measures., Methods: A survey of neuromuscular injuries associated with laparoscopy submitted to 18 institutions in the United States was completed by 18 attending urologists from 15 institutions., Results: From among a total of 1651 procedures, there were 46 neuromuscular injuries in 45 patients (2.7%), including abdominal wall neuralgia (14), extremity sensory deficit (12), extremity motor deficit (8), clinical rhabdomyolysis (6), shoulder contusion (4), and back spasm (2). Neuromuscular injuries were twice as common with upper retroperitoneal as with pelvic laparoscopy (3. 1% versus 1.5%). Among patients with neuromuscular injuries, those with rhabdomyolysis were heavier (means 91 versus 80 kg) and underwent longer procedures (means 379 versus 300 minutes), and those with motor deficits were older (means 51 versus 42 years of age). Of the surgeons, 28% and 17% reported frequent neck and shoulder pain, respectively., Conclusions: Although not common, neuromuscular injuries during laparoscopy do contribute to morbidity. Abdominal wall neuralgias, injuries to peripheral nerves, and joint or back injuries likely occur no more frequently than during open surgery, but risk of rhabdomyolysis may be increased. Positioning in a partial rather than full flank position may reduce the incidence of some injuries. Measures to reduce neuromuscular strain on the surgeon during laparoscopy should be considered.

Objectives: To evaluate the efficacy of interstitial saline radiofrequency energy for reproducibly ablating nonmalignant (control) and malignant (the VX-2 tumor) renal tissue in a rabbit model, and to determine the ability of conventional gray-scale and power sonography to image the tumor and ablative process in real time before, during, and after treatment., Methods: The VX-2 tumor was implanted beneath the renal capsule in 18 rabbit kidneys. Twelve days after implantation, 50 W of 500-kHz radiofrequency energy was delivered into the surgically externalized renal tumor and contralateral control kidney for 30 or 45-second treatment intervals using an interstitial saline-augmented radiofrequency probe (the virtual electrode). Localization of the tumor and response to treatment were imaged with gray-scale and power Doppler ultrasonography. The effect of radiofrequency and extent of the destructive process on benign and malignant renal tissue were evaluated histologically., Results: Mean tumor size was 1.3 x 0.7 cm. Both 30 and 45-second treatment intervals provided marked tissue/tumor ablation. Gross anatomic and histologic analysis showed time-dependent ablated lesions averaging 1.4+/-0.3 x 1.0+/-0.3 cm (30-second treatment) and 1.8+/-0.4 x 1.5+/-0.3 cm (45-second treatment), with clear demarcation of the surrounding parenchyma. Conventional gray-scale sonography allowed visualization of the ablative process, and power Doppler ultrasound demonstrated changes in the vascular pattern of the tumor both before and after ablation. No immediate treatment-related complications were observed., Conclusions: These preliminary studies in a rabbit model demonstrate the feasibility of using the interstitial saline-augmented electrode to ablate small renal tumors and the ability to simultaneously visualize the ablative process using real-time ultrasonography. This technology may have the potential to treat small renal tumors in a minimally invasive manner in the clinical setting.

Objectives: Previous reports indicate that up to 10% of patients with localized renal cell carcinoma have direct intracaval neoplastic extension. Many patients with locally confined tumors and small intracaval tumor extensions can be surgically cured. Few studies have documented long-term survival after radical surgery for renal cell carcinoma involving higher vena caval tumor extension. We report the follow-up of 34 consecutive patients undergoing radical nephrectomy and intrahepatic or supradiaphragmatic intracaval thrombectomy for renal cell carcinoma., Methods: From October 1982 through January 1993, 34 consecutive patients with a mean age of 60 years were identified as having clinical Stage T3 renal cell carcinoma (mean diameter 9.5+/-4.0 cm) with intrahepatic (41%) or supradiaphragmatic (59%) intracaval neoplastic extension. Patients underwent radical nephrectomy with intrahepatic caval thrombectomy (38%) or supradiaphragmatic caval thrombectomy using cardiac bypass with hypothermia and circulatory arrest (62%). Clinical outcome was assessed during a mean follow-up of 30 months (range 1 to 182)., Results: A total of 24 (71%) of 34 tumors demonstrated capsular penetration, and 22 (65%) of 34 had significant perinephric extension into Gerota's fascia by pathologic analysis. Metastatic disease was identified in 35% of patients either at the time of surgery or by pathologic analysis. Using Kaplan-Meier actuarial analysis, the likelihood of survival for all 34 consecutive patients after surgery was 68% (95% confidence interval [CI] 49% to 81%) at 1 year, 32% (95% CI 18% to 48%) at 2 years, 14% (95% CI 5% to 28%) at 5 years, and 9% (95% CI 2% to 24%) at 10 years. Neither capsular penetration, perinephric extension, the level of intracaval extension of tumor, nor the use of cardiopulmonary bypass significantly affected survival., Conclusions: In patients with renal cell carcinoma and intrahepatic or supradiaphragmatic intracaval extension of tumor, the presence of metastases is a frequent occurrence and, if present, greatly diminishes survival. Improvements in the preoperative detection of occult metastases are needed if surgery alone is to improve survival.

Objectives: To evaluate the relative efficacy of brachytherapy to radical prostatectomy, we compared biochemical progression rates from a published series of men who underwent iodine 125 (125I) interstitial radiotherapy for localized prostate cancer to a similar group of men who underwent anatomic radical prostatectomy using appropriate end points., Methods: Seventy-six men who underwent anatomic radical prostatectomy between 1988 and 1990 were carefully matched for Gleason score and clinical stage to a recently reported contemporary series of patients treated at another institution with 125I brachytherapy without adjuvant treatment. The definition of biochemical progression was a serum PSA level greater than 0.2 ng/mL after anatomic radical prostatectomy and greater than 0.5 ng/mL for brachytherapy-treated patients., Results: The 7-year actuarial PSA progression-free survival following anatomic radical prostatectomy was 97.8% (95% confidence interval [CI], 85.6% to 99.7%) for this group of men selected to match the brachytherapy group, compared to 79% (95% CI not published) for men treated with 125I interstitial radiotherapy., Conclusions: Using comparative end points for biochemical-free progression, failure rates may be higher following 125I interstitial radiotherapy compared to anatomic radical prostatectomy. These data provide a better comparison of biochemical progression than previously published studies and emphasize the need for caution in interpreting the relative efficacy of brachytherapy in controlling localized prostate cancer.

Objectives: Laparoscopic retropubic urethropexy has recently been described as an alternative method to the surgical correction of pure stress urinary incontinence. This study compares the operative technique and results of laparoscopic colposuspension with traditional open Burch urethropexy to treat women with stress urinary incontinence., Methods: We assessed the short-term results of 12 women who underwent a modified laparoscopic Burch urethropexy for the correction of stress urinary incontinence and compared these with a similar contemporary group of 10 women who underwent a traditional open Burch colposuspension procedure., Results: Ten women (83%) who underwent the laparoscopic procedure are continent with a mean follow-up of 20.8 months, and 7 women (70%) who had an open Burch colposuspension are continent at a mean follow-up of 35.6 months. The laparoscopic procedure took an average of 1.5 hours longer than the open repair (P < 0.01). Patients who underwent the laparoscopic urethropexy required less postoperative analgesia (mean, 14.2 mg morphine equivalents versus 131.4 mg; P < 0.01), shorter length of hospitalization (mean, 1.9 days versus 4.9 days; P < 0.01), and a more expedient return to normal activity when compared with those who underwent open Burch colposuspension., Conclusions: Laparoscopic bladder neck suspension offers a less invasive approach to the surgical correction of stress urinary incontinence and can provide successful outcomes in properly selected patients.