REMOVED: The Augmenta Implant: A Cadaver Model of a Novel Anatomic Subdermal Implant for Cosmetic Penile Enhancement.

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Reduced Rate of Repeated Prostate Biopsies Observed in ConfirmMDx Clinical Utility Field Study.

BACKGROUND: The diagnosis of prostate cancer is dependent on histologic confirmation in biopsy core tissues. The biopsy procedure is invasive, puts the patient at risk for complications, and is subject to significant sampling errors. An epigenetic test that uses methylation-specific polymerase chain reaction to determine the epigenetic status of the prostate cancer-associated genes GSTP1, APC, and RASSF1 has been clinically validated and is used in clinical practice to increase the negative predictive value in men with no history of prostate cancer compared with standard histopathology. Such information can help to avoid unnecessary repeat biopsies. The repeat biopsy rate may provide preliminary clinical utility evidence in relation to this assay's potential impact on the number of unnecessary repeat prostate biopsies performed in US urology practices. OBJECTIVE: The purpose of this preliminary study was to quantify the number of repeat prostate biopsy procedures to demonstrate a low repeat biopsy rate for men with a history of negative histopathology who received a negative epigenetic assay result on testing of the residual prostate tissue. METHODS: In this recently completed field observation study, practicing urologists used the epigenetic test called ConfirmMDx for Prostate Cancer (MDxHealth, Inc, Irvine, CA) to evaluate cancer-negative men considered at risk for prostate cancer. This test has been previously validated in 2 blinded multicenter studies that showed the superior negative predictive value of the epigenetic test over standard histopathology for cancer detection in prostate biopsies. A total of 5 clinical urology practices that had ordered a minimum of 40 commercial epigenetic test requisitions for patients with previous, cancer-negative biopsies over the course of the previous 18 months were contacted to assess their interest to participate in the study. Select demographic and prostate-screening parameter information, as well as the incidence of repeat biopsy, specifically for patients with a negative test result, was collected and merged into 1 collective database. All men from each of the 5 sites who had negative assay results were included in the analysis. RESULTS: A total of 138 patients were identified in these urology practices and were included in the analysis. The median age of the men was 63 years, and the current median serum prostate-specific antigen level was 4.7 ng/mL. Repeat biopsies had been performed in 6 of the 138 (4.3%) men with a negative epigenetic assay result, in whom no evidence of cancer was found on histopathology. CONCLUSION: In this study, a low rate of repeat prostatic biopsies was observed in the group of men with previous histopathologically negative biopsies who were considered to be at risk for harboring cancer. The data suggest that patients managed using the ConfirmMDx for Prostate Cancer negative results had a low rate of repeat prostate biopsies. These results warrant a large, controlled, prospective study to further evaluate the clinical utility of the epigenetic test to lower the unnecessary repeat biopsy rate.

A multicenter study on the perineal versus penoscrotal approach for implantation of an artificial urinary sphincter: cuff size and control of male stress urinary incontinence.

PURPOSE: In a single center retrospective study we previously reported superior dry rates and fewer artificial urinary sphincter revisions when the sphincter cuff was placed via the traditional perineal approach compared with a penoscrotal approach. A multicenter study was performed to compare the approaches further and explain the disparity in outcomes. MATERIALS AND METHODS: We performed a retrospective review of 158 patients who underwent these procedures from April 1987 to October 2007 at 4 centers. RESULTS: During 184 surgeries in 158 patients 201 artificial urinary sphincter cuffs were placed (90 penoscrotal and 111 perineal). Among patients with known followup the completely dry rate for single cuff artificial urinary sphincters was 17 of 62 (27.4%) in the penoscrotal group and 41 of 93 (44.1%) in the perineal group (p = 0.04). Continued incontinence necessitated subsequent tandem cuff in 7 of the 62 (11.3%) penoscrotal cases compared to only 5 of the 93 (5.4%) perineal cases. Cuff size in the penoscrotal group was 5.0 cm in 1 patient (1.1%), 4.5 cm in 11 (12.2%) and 4.0 cm in 78 (86.7%). Cuff size in the perineal group was 5.5 cm in 1 patient (0.9%), 5.0 cm in 8 (7.2%), 4.5 cm in 30 (27.0%) and 4.0 cm in 72 (64.9%). CONCLUSIONS: There appears to be a higher completely dry rate with fewer subsequent tandem cuff additions with the perineal approach compared to the penoscrotal approach. This disparity may be explained by a more proximal artificial urinary sphincter cuff placement in the perineal group as evidenced by a larger cuff size.

Neuroepithelial interactions in prostate cancer are enhanced in the presence ofprostatic stroma.

OBJECTIVES: To develop an in vitro model that tests the involvement of prostatic stroma in the active reciprocal interactions between malignant epithelial cells and nerves that occur in perineural invasion. METHODS: Each of three metastatic prostate cancer cell lines (LnCaP, PC3, and DU-145 at 10(3)) was co-cultured in sextuplet experiments with a human prostate stromal cell line (HTS-40C at 10(3)) and a mouse dorsal root ganglion in matrigel for 13 days. Carcinoma/ganglia co-cultures (10(6) cells) in the absence of stroma served as controls. Areas of carcinoma cell growth (day 1), neurite growth (days 1 and 3), and perineural invasion (neuroepithelial halo area, day 11) were quantified. RESULTS: Mean neurite outgrowth was enhanced in the presence of stroma with LnCaP and PC3, but not with DU-145. Perineural invasion and carcinoma cell growth were enhanced in the presence of stroma in experiments with all three cell lines. The mean cell area (in square millimeters) increased 54.7% with LnCaP in the presence of stroma (P <0.001). PC3 and DU-145 growth was enhanced 88.5% and 43.4%, respectively, in the presence of stroma. The mean neurite growth (in millimeters) on days 1 and 3 increased 50.8% and 70.8% with LnCaP in the presence of stroma. This enhancement was observed with PC3 by 88.1% and 64.5%. The mean neurite growth decreased in the presence of stroma with DU-145 by 4.9% and 5.4%. Perineural invasion increased 33.8% in the presence of stroma with LnCaP and 24.3% and 26.1% with PC3 and DU-145, respectively. CONCLUSIONS: These novel findings strongly suggest active stromal participation in perineural invasion. The identification of specific stromal factors may suggest ways of preventing the progression of prostate cancer.