Temporarily implanted nitinol device versus prostatic urethral lift for minimally invasive surgical treatment of benign prostatic hyperplasia with lower urinary tract symptoms: a matching-adjusted indirect comparison.

INTRODUCTION: To evaluate the safety and efficacy of the temporarily implanted nitinol device (iTind) versus prostatic urethral lift (PUL) for minimally invasive surgical treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia in a matching-adjusted indirect comparison (MAIC). MATERIALS AND METHODS: Seven clinical trials were identified via a systematic literature review. Individual patient data from iTind trials and aggregated data from PUL trials were used in the MAIC. Safety and efficacy outcomes at 12 months post-treatment were compared between the adjusted iTind population and the pooled PUL population. RESULTS: iTind patients were significantly less likely than PUL patients to experience treatment-related adverse events within 3 months (25.0% vs. 79.8%; p < 0.001), including dysuria (17.8% vs. 34.7%; p = 0.001), hematuria (12.0% vs. 25.9%; p = 0.002), and pain (9.5% vs. 18.7%; p = 0.023). Rates of treatment-related adverse events from 3 to 12 months were also significantly lower among iTind than PUL patients (2.6% vs. 24.4%; p < 0.001). iTind and PUL efficacy outcomes were statistically equivalent on changes from baseline to 12 months on the International Prostate Symptom Score, quality of life, Qmax, post-void residual volume, and the Sexual Health Inventory for Men (all p > 0.05). CONCLUSIONS: This MAIC found superior safety and reduced risks of early and later treatment-related adverse events with iTind versus PUL. The 12-month efficacy was equivalent on subjective and objective urinary and sexual health metrics. This study finds that the iTind temporary device provides equivalent efficacy with lower adverse event risks versus the PUL permanent implants for patients with benign prostatic hyperplasia with lower urinary tract symptoms.

Real-World Prostate-Specific Antigen Response and Treatment Adherence of Apalutamide in Patients With Non-Metastatic Castration-Resistant Prostate Cancer.

OBJECTIVE: To describe prostate-specific antigen (PSA) response and treatment adherence, overall and stratified by race, for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with apalutamide. METHODS: Electronic medical records representing 63 urology practices from the United States were used to conduct this study. Patients with ≥2 apalutamide prescription fills and ≥12 months of prior prostate cancer management were identified. Patients were followed from apalutamide initiation until a switch to another antineoplastic treatment, death, or end of data availability (October 4, 2019). PSA response (≥50% decline from baseline PSA) and apalutamide adherence rates are described for the overall nmCRPC population treated and also stratified by race (Black and non-Black cohorts). RESULTS: Overall, 193 patients with nmCRPC were initiated on apalutamide. Thirty-three patients were Black (17.1%), 138 were non-Black (71.5%), and the remaining had an unknown racial background. The mean baseline PSA level for the overall, Black, and non-Black cohorts, was 7.0 ng/mL, 10.5 ng/mL, and 5.6 ng/mL, respectively. At 12 months of follow-up, PSA response was 86.0%, 93.1%, and 85.9% for the overall, Black, and non-Black cohorts, respectively. During a mean follow-up period of 333 days, 352 days, and 326 days, adherence was 93.6%, 90.1%, and 94.5% for the overall, Black and non-Black cohorts, respectively. CONCLUSION: This real-world study of patients with nmCRPC initiated on apalutamide showed that PSA response was robust and consistent with clinical trial data. Moreover, both Black and non-Black patients demonstrated high treatment adherence.

Evaluation of an RNAseq-Based Immunogenomic Liquid Biopsy Approach in Early-Stage Prostate Cancer.

The primary objective of this study is to detect biomarkers and develop models that enable the identification of clinically significant prostate cancer and to understand the biologic implications of the genes involved. Peripheral blood samples (1018 patients) were split chronologically into independent training (n = 713) and validation (n = 305) sets. Whole transcriptome RNA sequencing was performed on isolated phagocytic CD14+ and non-phagocytic CD2+ cells and their gene expression levels were used to develop predictive models that correlate to adverse pathologic features. The immune-transcriptomic model with the highest performance for predicting adverse pathology, based on a subtraction of the log-transformed expression signals of the two cell types, displayed an area under the curve (AUC) of the receiver operating characteristic of 0.70. The addition of biomarkers in combination with traditional clinical risk factors (age, serum prostate-specific antigen (PSA), PSA density, race, digital rectal examination (DRE), and family history) enhanced the AUC to 0.91 and 0.83 for the training and validation sets, respectively. The markers identified by this approach uncovered specific pathway associations relevant to (prostate) cancer biology. Increased phagocytic activity in conjunction with cancer-associated (mis-)regulation is also represented by these markers. Differential gene expression of circulating immune cells gives insight into the cellular immune response to early tumor development and immune surveillance.

National Cancer Database Comparison of Radical Cystectomy vs Chemoradiotherapy for Muscle-Invasive Bladder Cancer: Implications of Using Clinical vs Pathologic Staging.

PURPOSE: To test the hypothesis that bladder preservation therapy consisting of definitive chemoradiotherapy (chemoRT) results in similar overall survival rates to radical cystectomy/chemotherapy when balancing baseline patient characteristics and initial (preoperative) clinical stage. MATERIALS/METHODS: A total of 7,322 patients with stage II-IV, M0 bladder cancer who were treated with cystectomy/chemo (N = 5,664) or definitive chemoRT (N = 1,658) were identified from the National Cancer Database. Baseline patient characteristics were compared using Pearson's chi-square, Fisher's exact test, and Wilcoxon's rank sum tests. Cox regressions were used to investigate for variables significantly correlated with overall survival (OS). OS was compared between cystectomy/chemo vs chemoRT before and after propensity score matched pair analyses using Kaplan-Meier curves and log-rank tests. RESULTS: Patients who underwent cystectomy/chemo were significantly younger than ones treated with definitive chemoRT (mean age 63.7 vs 75.2; P < 0.001). Age, race, Charlson/Deyo Comorbidity Score (CDCS), clinical stage, insurance status, and type of facility significantly correlated with OS (P < 0.05 for all covariates). Patients treated with cystectomy/chemo were younger, healthier with better CDCS, and more likely treated at academic facilities. Before matched pair analyses, OS was significantly better when treated with cystectomy/chemo (3 year 56.4%; 5 year 45.9%) compared to chemoRT (3 year 47.3%; 5 year 33.2%) (P < 0.001); 28.6% of patients undergoing cystectomy were upstaged at the time of surgery. After matched pair analyses matching age, race, sex, CDCS, clinical (presurgical) stage, insurance, and facility type (N = 1,750), OS was no longer significantly different between cystectomy/chemo (3 year 52.1% and 5 year 41.0%) vs chemoRT (3 year 53.3% and 5 year 40.1%) (P = 0.5). CONCLUSIONS: Patients treated with cystectomy/chemo were significantly younger and healthier compared to those treated with chemoRT. Once these factors were accounted for in propensity score matched pair analyses using clinical stage, overall survival was not significantly different between cystectomy/chemo and an organ-sparing approach with definitive chemoRT.

The Single-parameter, Structure-based IsoPSA Assay Demonstrates Improved Diagnostic Accuracy for Detection of Any Prostate Cancer and High-grade Prostate Cancer Compared to a Concentration-based Assay of Total Prostate-specific Antigen: A Preliminary Report.

BACKGROUND: IsoPSA is a serum-based assay that predicts prostate cancer (PCa) risk by partitioning isoforms of prostate-specific antigen (PSA) with an aqueous two-phase reagent. OBJECTIVES: To determine the diagnostic accuracy of IsoPSA in identifying the presence or absence of PCa and the presence of high-grade disease in a contemporary biopsy cohort. DESIGN, SETTING, AND PARTICIPANTS: Multicenter prospective study of 261 men scheduled for prostate biopsy at five academic and community centers in the USA enrolled between August 2015 and December 2016. INTERVENTION: Performance of the IsoPSA assay. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Discrimination power was evaluated using receiver operating characteristic (ROC) analysis. The outcome of the IsoPSA assay was transformed into risk probability using logistic regression. Decision curve analysis (DCA) was used to compare the net benefit of IsoPSA against other clinical protocols. RESULTS AND LIMITATIONS: The overall prevalence was 53% for any PCa and 34% for high-grade PCa. The area under the ROC curve was 0.79 for any cancer versus none and 0.81 for high-grade PCa versus low-grade PCa/benign histology. In this preliminary study, DCA revealed a superior net benefit of IsoPSA against no biopsy, all biopsy, and the modified Prostate Cancer Prevention Trial Risk Calculator 2.0. At a cutoff selected to recommend biopsy, IsoPSA demonstrated a 48% reduction in false-positive biopsies; at a cutoff selected to identity men at low risk of high-grade disease, there was a 45% reduction in the false-positive rate. CONCLUSION: The structure-based IsoPSA assay outperformed concentration-based PSA measurement, and provided a net benefit against other protocols. Once validated, clinical use of IsoPSA could significantly reduce unnecessary biopsies while identifying patients needing treatment. PATIENT SUMMARY: The IsoPSA assay outperformed prostate-specific antigen in predicting the overall risk of prostate cancer and the risk of clinically significant cancer in a preliminary study. The IsoPSA assay could assist in determining the need for prostate biopsy for patients.

How I do it: Same day discharge for transurethral resection of prostate using Olympus PlasmaButton and PlasmaLoop.

Benign prostatic hyperplasia (BPH) is one of the most common conditions affecting older men. Transurethral resection of the prostate (TURP) has widely been considered the gold standard in surgical treatment for BPH. However, this procedure remains largely an inpatient procedure. Inpatient admission ultimately adds to healthcare cost and patient morbidity. In this article, we present an alternative methodology to treat BPH using combination Olympus PlasmaButton and Olympus PlasmaLoop therapy. Preliminary results from our experience suggest improved hemostasis with adequate resection, allowing a majority of our patients to be discharged the same day of the procedure. We describe our novel technique as a safe and effective way to possibly treat BPH in an outpatient setting.

Minimally invasive prostate cancer detection test using FISH probes.

PURPOSE: The ability to test for and detect prostate cancer with minimal invasiveness has the potential to reduce unnecessary prostate biopsies. This study was conducted as part of a clinical investigation for the development of an OligoFISH(®) probe panel for more accurate detection of prostate cancer. MATERIALS AND METHODS: One hundred eligible male patients undergoing transrectal ultrasound biopsies were enrolled in the study. After undergoing digital rectal examination with pressure, voided urine was collected in sufficient volume to prepare at least two slides using ThinPrep. Probe panels were tested on the slides, and 500 cells were scored when possible. From the 100 patients recruited, 85 had more than 300 cells scored and were included in the clinical performance calculations. RESULTS: Chromosomes Y, 7, 10, 20, 6, 8, 16, and 18 were polysomic in most prostate carcinoma cases. Of these eight chromosomes, chromosomes 7, 16, 18, and 20 were identified as having the highest clinical performance as a fluorescence in situ hybridization test and used to manufacture the fluorescence in situ hybridization probe panels. The OligoFISH(®) probes performed with 100% analytical specificity. When the OligoFISH(®) probes were compared with the biopsy results for each individual, the test results highly correlated with positive and negative prostate biopsy pathology findings, supporting their high specificity and accuracy. Probes for chromosomes 7, 16, 18, and 20 showed in the receiver operator characteristics analysis an area under the curve of 0.83, with an accuracy of 81% in predicting the biopsy result. CONCLUSION: This investigation demonstrates the ease of use with high specificity, high predictive value, and accuracy in identifying prostate cancer in voided urine after digital rectal examination with pressure. The test is likely to have positive impact on clinical practice and advance approaches to the detection of prostate cancer. Further evaluation is warranted.

One-year monitoring of an oligonucleotide fluorescence in situ hybridization probe panel laboratory-developed test for bladder cancer detection.

BACKGROUND: Previously, we had developed and manufactured an oligonucleotide fluorescence in situ hybridization (OligoFISH) probe panel based on the most clinically sensitive chromosomes found in a reference set of bladder carcinoma cases. The panel was clinically validated for use as a diagnostic and monitoring assay for bladder cancer, reaching 100% correlation with the results of the UroVysion test. After 1 year of using this probe panel, we present here the comparison of cytology, cystoscopy, and pathology findings to the OligoFISH probe panel results to calculate its clinical performance. MATERIALS AND METHODS: In order to calculate clinical performance, we compared the OligoFISH results to the cytology and cystoscopy/pathology findings for 147 initial diagnoses and 399 recurrence monitorings. Finally, we compared clinical performance to published values for the UroVysion test, including both low- and high-grade tumors. RESULTS: Chromosomes 3, 6, 7, and 20 were highly involved in bladder carcinoma aneuploidy. At the initial diagnosis, we obtained 90.5% (95% confidence interval [CI]: 84.5%-94.7%) accuracy, 96.8% sensitivity (95% CI: 91.0%-99.3%), 79.2% specificity (95% CI: 65.9%-87.8%), 89.2% positive predictive value (PPV; 95% CI: 81.5%-94.5%), and 93.3% negative predictive value (NPV; 95% CI: 81.7%-97.3%). When monitoring for recurrence, we obtained 85.2% accuracy (95% CI: 81.3%-88.5%), 82.0% sensitivity (95% CI: 76.0%-87.1%), 88.4% specificity (95% CI: 83.2%-92.5%), 87.7% PPV (95% CI: 82.1%-92.0%), and 83.0% NPV (95% CI: 77.3%-87.8%). When looking at low- and high-grade tumors, the test showed 100% sensitivity for high-grade tumors (95% CI: 92.5%-100%) and 87.5% sensitivity (95% CI: 68.8%-95.5%) for low-grade tumors. All the clinical parameters for the OligoFISH panel were higher than the UroVysion test's published performance. We found significantly higher clinical sensitivity and NPV at initial diagnosis and significantly higher specificity and PPV for recurrence. CONCLUSION: The OligoFISH probe panel is a fast, easy, and reproducible test for bladder cancer diagnosis and monitoring, with excellent clinical performance and utility.

The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices.

There is significant concern regarding prostate cancer screening because of the potential for overdiagnosis and overtreatment of men who are discovered to have abnormal prostate specific antigen (PSA) levels and/or digital rectal examination (DRE) results. The 4Kscore® Test (OPKO Diagnostics, LLC) is a blood test that utilizes four kallikrein levels plus clinical information in an algorithm to calculate an individual's percentage risk (< 1% to > 95%) for aggressive prostate cancer (Gleason score ≥ 7) on prostate biopsy. The 4Kscore Test, as a follow-up test after abnormal PSA and/or DRE test results, has been shown to improve the specificity for predicting the risk of aggressive prostate cancer and reduce unnecessary prostate biopsies. A clinical utility study was conducted to assess the influence of the 4Kscore Test on the decision to perform prostate biopsies in men referred to urologists for abnormal PSA and/or DRE results. The study population included 611 patients seen by 35 academic and community urologists in the United States. Urologists ordered the 4Kscore Test as part of their assessment of men referred for abnormal PSA and/or DRE test results. Results for the patients were stratified into low risk (< 7.5%), intermediate risk (7.5%-19.9%), and high risk (≥ 20%) for aggressive prostate cancer. The 4Kscore Test results influenced biopsy decisions in 88.7% of the men. Performing the 4Kscore Test resulted in a 64.6% reduction in prostate biopsies in patients; the actual percentage of cases not proceeding to biopsy were 94.0%, 52.9%, and 19.0% for men who had low-, intermediate-, and high-risk 4Kscore Test results, respectively. A higher 4Kscore Test was associated with greater likelihood of having a prostate biopsy (P < 0.001). Among the 171 patients who had a biopsy, the 4Kscore risk category is strongly associated with biopsy pathology. The 4Kscore Test, as a follow-up test for an abnormal PSA and/or DRE results, significantly influenced the physician and patient shared decision in clinical practice, which led to a reduction in prostate biopsies while increasing the probability of detecting aggressive cancer.

Urine kidney injury molecule-1: a potential non-invasive biomarker for patients with renal cell carcinoma.

BACKGROUND: KIM-1 staining is upregulated in proximal tubule-derived renal cell carcinoma (RCC) including clear renal cell carcinoma and papillary renal cell carcinoma, but not in chromophobe RCC (distal tubular tumor). This study was designed to prospectively examine urine KIM-1 level before and 1 month after removal of renal tumors. PATIENTS AND DESIGN: A total of 19 patients were eventually enrolled in the study based on pre-operative imaging studies. Pre-operative and follow-up (1 month) urine KIM-1 levels were measured. The urine KIM-1 levels (uKIM-1) were then normalized to urine creatinine levels (uCr). Renal tumors were also stained for KIM-1 using immunohistochemical techniques. RESULTS: The KIM-1-negative staining group included 7 cases, and the KIM-1-positive group consisted of 12 cases. The percentage of KIM-1-positive staining RCC cells ranged from 10 to 100 %, and the staining intensity ranged from 1+ to 3+. In both groups, serum creatinine levels were both significantly elevated after nephrectomy. In the KIM-1-negative group, uKIM-1/uCr remained at a similar level before (0.37 ± 0.1 ng/mg Cr) and after nephrectomy (0.32 ± 0.01 ng/mg Cr). However, in the KIM-1-positive group, elevated uKIM-1/uCr at 1.20 ± 0.31 ng/mg Cr was significantly reduced to 0.36 ± 0.1 ng/mg Cr, which was similar to the pre-operative uKIM-1/uCr (0.37 ± 0.1 ng/mg Cr) in the KIM-1-negative group. CONCLUSION: Our small but prospective study showed significant reduction in uKIM-1/uCr after nephrectomy in the KIM-1 positive group, suggesting that urine KIM-1 may serve as a surrogate biomarker for kidney cancer and a non-invasive pre-operative measure to evaluate the malignant potential of renal masses.

Impact of a prostate multidisciplinary clinic program on patient treatment decisions and on adherence to NCCN guidelines: the William Beaumont Hospital experience.

OBJECTIVES: In order to demonstrate the impact of multidisciplinary care in the community oncology setting, we evaluated treatment decisions after the initiation of a dedicated prostate and genitourinary (GU) multidisciplinary clinic (MDC). METHODS: In March 2010, a GU MDC was created at William Beaumont Hospital with the goal of providing patients with a comprehensive multidisciplinary evaluation and consensus treatment recommendations in a single visit. Urologists, radiation, and medical oncologists along with ancillary support staff participated in this comprehensive initial evaluation. The impact of this experience on patient treatment decisions was analyzed. RESULTS: During the first year, a total of 182 patients were seen. Compared with previous years, low-risk MDC patients more frequently chose external beam radiation therapy (41.1% vs. 26.6%, P=0.02), and active surveillance (14.3% vs. 6.1%, P=0.02) and less frequently prostatectomy (30.4% vs. 44.0%, P=0.03). Similar increases in external beam were seen in intermediate and high-risk patients. Increased use of hormonal therapy was found in high-risk patients compared with the years before the initiation of the MDC (76.2% vs. 51.1%, P=0.03). Increased adherence to National Comprehensive Cancer Network (NCCN) guidelines was seen with intermediate-risk patients (89.8% vs. 75.9%, P=0.01), whereas nonsignificant increases were seen in low-risk (100% vs. 98.9%, P=0.43) and high-risk patients (100% vs. 94.2%, P=0.26). CONCLUSIONS: The establishment of a GU MDC improved the quality of care for cancer patients as demonstrated by improved adherence to National Comprehensive Cancer Network guidelines, and a broadening of treatment choices made available.

Dose escalation improves cancer-related events at 10 years for intermediate- and high-risk prostate cancer patients treated with hypofractionated high-dose-rate boost and external beam radiotherapy.

PURPOSE: To evaluate the 10-year outcomes of intermediate- and high-risk prostate cancer patients treated with a prospective dose escalation hypofractionated trial of pelvic external beam radiation therapy (P-EBRT) with a high-dose-rate (HDR) brachytherapy boost. METHODS AND MATERIALS: From 1992 to 2007, 472 patients were treated with a HDR boost at William Beaumont Hospital. They had at least one of the following: a prostate-specific antigen (PSA) level of >10 ng/ml, a Gleason score of ≥7, or clinical stage ≥T2b. Patients received 46-Gy P-EBRT and an HDR boost. The HDR dose fractionation was divided into two dose levels. The prostate biologically equivalent dose (BED) low-dose-level group received <268 Gy, and the high-dose group received >268 Gy . Phoenix biochemical failure (BF) definition was used. RESULTS: Median follow-up was 8.2 years (range, 0.4-17 years). The 10-year biochemical failure rate of 43.1% vs. 18.9%, (p < 0.001), the clinical failure rate of 23.4% vs. 7.7%, (p < 0.001), and the distant metastasis of 12.4% vs. 5.7%, (p = 0.028) were all significantly better for the high-dose level group. On Cox multivariate analysis, higher BED levels (p = 0.017; hazard ratio [HR] = 0.586), pretreatment PSA assays (p < 0.001, HR = 1.022), and Gleason scores (p = 0.004) were significant variables for reduced biochemical failure. Higher dose levels (p, 0.002; HR, 0.397) and Gleason scores (p < 0.001) were significant for clinical failure. Grade 3 genitourinary complications were 2% and 3%, respectively, and grade 3 gastrointestinal complication was <0.5%. CONCLUSIONS: This prospective trial using P-EBRT with HDR boost and hypofractionated dose escalation demonstrates a strong dose-response relationship for intermediate- and high-risk prostate cancer patients. The improvement at 10 years for locoregional control with higher radiation doses (BED, > 268 Gy) has significantly decreased biochemical and clinical failures as well as distant metastasis.

Cone beam computed tomography: an assessment of renal image quality and applicability for percutaneous renal cryotherapy in a swine model.

OBJECTIVES: To assess cone bean computed tomography (CBCT) for renal imaging in a phantom model, ex vivo kidney and an in vivo porcine percutaneous renal cyroablation (PRC). CBCT provides 3-dimensional sectional imaging without the space requirements, repositioning, and expenditure of computed tomography (CT). METHODS: CBCT was focused on a radiological phantom with electron density of renal tissue and visualization was recorded. The ability of CBCT to image an ex vivo kidney in a water bath, with and without contrast, was then evaluated. An in vivo porcine animal model was then used to perform PRC and the scanner was evaluated in regard to image of the kidneys, a fiber-agarose pseudotumor, and guidance of the cryoprobe. RESULTS: Qualitative assessment of phantom images revealed sufficient contrast between the renal tissue and water densities. Images of the ex vivo porcine kidneys without contrast revealed limited renal architecture, whereas retrograde contrast revealed 3D images of renal shape and vascular/collecting system architecture visible in axial and sagittal planes. Noncontrast imaging facilitated precise needle guidance but was inadequate to consistently visualize ice-ball formation during cryoablation. At necropsy, all tumors were encompassed by the cryolesion with >1-cm margins, except for 1 pseudotumor that had been placed extracapsularly. CONCLUSIONS: CBCT is an imaging modality capable of excellent spatial resolution and soft-tissue sensitivity in a radiographic phantom and ex vivo and in situ porcine renal models. Based on our preliminary results, further refinements in image quality are required to improve soft tissue visualization to be applied to percutaneous renal cryoablation.

Insight into current surgical techniques and practice patterns associated with robotic-assisted radical prostatectomy: a national survey of urologists within the USA.

Robotic-assisted radical prostatectomy (RARP) has been rapidly adopted throughout the USA. The purpose of this study is to describe the prevailing RARP operative techniques and perceptions within the USA. An anonymous web-based survey was sent electronically to a list of 920 robotic urological surgeons. The survey assessed surgeon demographics, surgical technique, and postoperative care related to RARP. The study was comprised of urologists from community hospitals (76%) and university hospitals/specialty centers (24%). All geographic sections of the American Urological Association were represented. The most common neurovascular preservation techniques were ante/retrograde approach (48%), athermal (22%), and preservation of lateral pelvic fascia (17%). Surgeon choice of neurovascular preservation technique varied with the average number of procedures performed per year (P = 0.0065). High-volume surgeons tended to require a higher number of robotic cases in order to go through the learning curve of the "comfortable" (P = 0.001) and "expert" levels (P < 0.0001). The majority of surgeons reported that RARP (as compared with open surgery) improved urinary continence (77.2%), sexual function (65.6%), and surgical margin rates (53.8%). RARP is an evolving surgical procedure with significant variability in practice patterns among US surgeons. Further studies are necessary to compare the various techniques in order to improve surgical outcomes.

Clinicopathologic analysis of extracapsular extension in prostate cancer: should the clinical target volume be expanded posterolaterally to account for microscopic extension?

PURPOSE: We performed a complete pathologic analysis examining extracapsular extension (ECE) and microscopic spread of malignant cells beyond the prostate capsule to determine whether and when clinical target volume (CTV) expansion should be performed. METHODS AND MATERIALS: A detailed pathologic analysis was performed for 371 prostatectomy specimens. All slides from each case were reviewed by a single pathologist (N.S.G.). The ECE status and ECE distance, defined as the maximal linear radial distance of malignant cells beyond the capsule, were recorded. RESULTS: A total of 121 patients (33%) were found to have ECE (68 unilateral, 53 bilateral). Median ECE distance=2.4 mm [range: 0.05-7.0 mm]. The 90th-percentile distance = 5.0 mm. Of the 121 cases with ECE, 55% had ECE distance>or=2 mm, 19%>or=4 mm, and 6%>or=6 mm. ECE occurred primarily posterolaterally along the neurovascular bundle in all cases. Pretreatment prostrate-specific antigen (PSA), biopsy Gleason, pathologic Gleason, clinical stage, bilateral involvement, positive margins, percentage of gland involved, and maximal tumor dimension were associated with presence of ECE. Both PSA and Gleason score were associated with ECE distance. In all 371 patients, for those with either pretreatment PSA>or=10 or biopsy Gleason score>or=7, 21% had ECE>or=2 mm and 5%>or=4 mm beyond the capsule. For patients with both of these risk factors, 49% had ECE>or=2 mm and 21%>or=4 mm. CONCLUSIONS: For prostate cancer with ECE, the median linear distance of ECE was 2.4 mm and occurred primarily posterolaterally. Although only 5% of patients demonstrate ECE>4 to 5 mm beyond the capsule, this risk may exceed 20% in patients with PSA>or=10 ng/ml and biopsy Gleason score>or=7. As imaging techniques improve for prostate capsule delineation and as radiotherapy delivery techniques increase in accuracy, a posterolateral CTV expansion should be considered for patients at high risk.

Squamous cell carcinoma in a female urethral diverticulum.

A 38-year-old woman was found to have a squamous cell carcinoma in a urethral diverticulum after a simple diverticulectomy. The aggressiveness of this histologic subtype of carcinoma, along with this patient's long life expectancy, supported the choice of aggressive therapy. Only nine other cases have been reported. A brief review of the published reports on the presentation, diagnosis, options for treatment, and outcomes is included.