Holmium Laser En-bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle-invasive Bladder Cancer: A Randomized Clinical Trial.

BACKGROUND: En-bloc resection of bladder tumors achieves complete tumor removal, improves the quality of resection, decreases perioperative complication, and potentially improves recurrence rates. OBJECTIVE: To assess the efficacy and safety of holmium laser en-bloc resection (HolERBT) versus conventional transurethral resection of bladder tumor (cTURBT). DESIGN, SETTING, AND PARTICIPANTS: Between September 2015 and September 2018, 100 patients with non-muscle-invasive bladder cancer were randomly allocated to cTURBT or HolERBT. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was detection of residual tumor in reTURBT specimens at 4 wk after the primary resection. Operative parameters, specimen quality, perioperative complications, and recurrence-free survival (RFS) were compared. Independent sample t tests, χ2 tests, and Kaplan-Meier curves were used, as appropriate. RESULTS AND LIMITATIONS: The patient and tumor baseline characteristics were comparable between the groups. Residual tumors were detected in 7% and 27.7% of cases after HolERBT and cTURBT, respectively (p=0.01). Detrusor muscle was sampled in 98% of HolERBT and 62% of cTURBT cases (p<0.001). Lamina propria invasion substaging was feasible in only 68.2% of HolERBT and 18.4% of cTURBT cases (p<0.001). Following HolERBT, catheterization time (p<0.001) and hospital stay (p=0.001) were shorter when compared to cTURBT. Immediate postoperative instillation of chemotherapy in indicated cases was feasible for 100% of the HolERBT group and 91.5% of the cTURBT group (p=0.04). After follow-up of 20 ± 9.9 mo (13-36), RFS was 31.76 mo (95% confidence interval [CI] 28.67-34.86) in the HolERBT group and 28.25 mo (95% CI 24.87-31.64) in the cTURBT group (hazard ratio 0.43, 95% CI 0.17-1.1; p=0.07). However, this study was not powered to detect a difference in RFS. CONCLUSIONS: Compared to cTURBT, HolERBT is a safer procedure for bladder tumor resection. It fulfills the oncological criteria of optimized resection with less residual tumor and better specimen quality. PATIENT SUMMARY: En-bloc resection of bladder cancer tumors using a holmium laser is safer than the conventional technique. It has the advantages of less residual tumor and better specimen quality, with a similar tumor recurrence rate. This study is registered at ClinicalTrials.gov as NCT02555163.

Is transition zone biopsy valuable in benign prostatic hyperplasia patients with serum prostate-specific antigen >10 ng/ml and prior negative peripheral zone biopsy?

OBJECTIVES: To evaluate the importance of transition zone (TZ) biopsy in benign prostatic hyperplasia (BPH) patients with serum prostate-specific antigen (PSA) >10 ng/ml and prior negative peripheral zone (PZ) biopsy and to estimate the sensitivity of TZ biopsy. MATERIAL AND METHODS: A total of 273 BPH patients with PSA >10 ng/ml and prior negative PZ biopsy underwent an extended biopsy protocol. In patients with a TZ volume <25 cm(3), four TZ biopsies were taken (two cores per side from the apex and base). In patients with a TZ volume > or =25 cm(3) (n=183), six TZ biopsies were taken (three cores per side from the apex, middle and base). Overall, 215 patients were subjected to either transurethral resection of the prostate (n=162) or open enucleation of the adenoma (n=53). RESULTS: The extended biopsy revealed prostate cancers in 21.2% of cases (58/273). The zonal distribution of the positive cores was as follow: PZ cancers only in 67.2% of cases (39/58), TZ cancers only in 13.8% (8/58) and PZ+TZ cancers in 19% (11/58). Overall, 73.6% (14/19) and 36.8% (7/19) of TZ cancers were detected at the apex and middle of the TZ, respectively, while no TZ cancers at all were detected at the base (p=0.00015). The incidence of carcinoma on definitive pathology was 5.6% (12/215). Consequently, TZ biopsy detected only 61.3% (19/31) of TZ cancers. The incidence of pure TZ cancers was 7.3%. On the chi(2) test, patient age, serum PSA, transrectal ultrasonography findings and PSA density did not correlate significantly with the detection rate of TZ cancer. Prostate volume (p=0.023), TZ volume (p=0.027) and PSA/TZ density (p=0.007) were predictive of TZ cancers. CONCLUSIONS: Although TZ biopsy was the sole site of cancer in only 2.9% of cases (8/273), it improved the cancer detection rate by 14% in this selected group of patients. The majority (74%) of TZ cancers were detected at the apex site. TZ biopsy has a low sensitivity (61%).

Predictors of prostate cancer on extended biopsy in patients with high-grade prostatic intraepithelial neoplasia: a multivariate analysis model.

OBJECTIVE: To define the importance of extended biopsy in patients with high-grade prostatic intraepithelial neoplasia (HGPIN) and to define predictors of cancer in extended biopsy in patients with HGPIN, using multivariate analysis. PATIENTS AND METHODS: In all, 83 patients with previous sextant biopsy of HGPIN had an extended 11-core biopsy taken. Patients with a negative biopsy for cancer were followed by serum prostate-specific antigen (PSA) and digital rectal examination (DRE) every 6 months. The extended biopsy was repeated in 21 patients. The criteria for second biopsy were an increase in PSA and/or abnormal changes on DRE. Overall, 49 patients had a transurethral resection of the prostate (TURP). The cancer-detection rate on extended biopsy was correlated with risk factors using the chi-square test and multivariate analysis. RESULTS: Extended biopsy detected prostate cancer in 30 of the 83 men (36%), with positive cores in only 20 sextant biopsy sites (67%), in only seven in additional sites (23%), and both in three (10%). Of the 21 patients who had repeat extended biopsy, four (19%) had cancers. There were two carcinomas in the 49 TURP specimens (4%). The PSA level, DRE and transrectal ultrasonography findings were not predictive of cancer in extended biopsies (chi-square test). Patient age, PSA density and the number of cores with HGPIN (all P < 0.001) had a significant effect on the cancer-detection rate, and multivariate analysis showed that all three were independent predictors of cancer. A logistic regression model was designed to predict the probability of cancer in extended biopsy, with an overall accuracy of 78%. CONCLUSION: Extended biopsy improved the cancer detection rate by 23% in patients with HGPIN. Patient age, PSA density and the number of cores with HGPIN were the only independent predictors of cancer.

Is extended 11-core biopsy valuable in benign prostatic hyperplasia patients with intermediate serum prostate-specific antigen (4.1-10 ng/ml) and prior negative sextant biopsy?

OBJECTIVE: To evaluate the importance of extended 11-core biopsy in benign prostatic hyperplasia (BPH) patients with intermediate prostate-specific antigen (PSA; 4.1-10 ng/ml) and prior negative sextant biopsy. MATERIAL AND METHODS: A total of 381 BPH patients with intermediate PSA (4.1-10 ng/ml) and prior negative sextant biopsy underwent extended 11-core biopsy, which included conventional sextant biopsy in addition to five cores from three alternative sites. Two cores were taken from the right and left anterior horns of the peripheral zone (PZ), two from the right and left anterior transition zones (TZs) and one from the midline of the PZ. Overall, 315 patients were subjected to transurethral resection of the prostate (n = 272) or open prostatectomy (n = 43). RESULTS: Repeat 11-core biopsy revealed prostate cancer in 66/381 cases (17.3%). The distribution of positive cores on repeat 11-core biopsy was as follows: sextant biopsy sites only in 50% of cases (33/66); alternative sites only in 31.8% (21/66); and sextant plus alternative biopsy sites in 18.2% (12/66). The anterior horn of the PZ was the most frequently positive alternative site (25/33; 75.8%), followed by the TZ (5/33; 15.2%), while the midline site was involved in 9% of cases (3/33). Eleven-core biopsy had a significantly better cancer detection rate compared to sextant biopsy when digital rectal examination was normal (p = 0.009), prostate volume was in the range 30-50 cm (p = 0.033) and PSA density was > or =0.15 (p = 0.024). Six cancer cases out of 315 (1.9%) were diagnosed as a result of the definitive pathology. The sensitivity of 11-core biopsy was 91.6%, compared to 62.5% for sextant biopsy (p < 0.001). CONCLUSION: An extended 11-core biopsy protocol is valuable in BPH patients with intermediate PSA (4.1-10 ng/ml) and prior negative sextant biopsy as it significantly improved the overall detection rate in our study by 32% (p = 0.019).