The use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography-guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously. (Funded by the National Institute for Health Research and the European Association of Urology Research Foundation; PRECISION ClinicalTrials.gov number, NCT02380027 .).
Purpose To assess the impact that improved detection of non-muscle invasive bladder cancer with hexaminolevulinate (HAL) fluorescence cystoscopy may have on early recurrence rates. Materials and methods This prospective, randomized study enrolled 814 patients suspected of having bladder cancer at increased risk for recurrence. All patients underwent white light cystoscopy and mapping of lesions, followed by transurethral resection of the bladder (TURB) where indicated. Patients in the fluorescence group also received intravesical hexaminolevulinate solution at least one hour before cystoscopy to induce fluorescence of cancerous lesions, and underwent additional inspection with blue light before and after TURB. Adjuvant intravesical therapy was based on risk. Follow up cystoscopies at 3, 6 and 9 months were conducted with white light. Results Detection was carried out as a within-patient comparison in the fluorescence group. In this group, 286 patients were found to have at least one Ta or T1 tumor (ITT). In 47 (16%), at least one of the tumors was seen only with fluorescence (p=0.001). During the 9 month follow-up period (ITT), there were tumor recurrences in 128/271 patients (47%) in the fluorescence group and 157/280 patients (56%) in the white light group (p=0.026). The relative reduction in recurrence rate was 16%. Conclusions HAL fluorescence cystoscopy significantly improves detection of Ta and T1 lesions and significantly reduces the rate of tumor recurrence at 9 months.
Convective water vapor thermal therapy provides rapid and durable improvements in benign prostatic hyperplasia symptoms and preserves erectile and ejaculatory function. Treatment can be delivered in an office or hospital setting using oral pain medication and is applicable to all prostate zones including the median lobe.
Purpose We assessed the impact that hexaminolevulinate fluorescence cystoscopic detection of papillary, non-muscle invasive bladder cancer has on long-term recurrence rates. Materials and Methods Long-term follow-up was assessed in 551 participants enrolled in a prospective, randomized study of fluorescence cystoscopy for Ta or T1 urothelial bladder cancer. In the original study, 280 patients in the white light cystoscopy group and 271 in the fluorescence cystoscopy group were followed with cystoscopy for 3, 6, and 9 months following the initial resection or until recurrence. A study extension protocol obtained long-term follow-up of these patients. Results Follow-up information was obtained for 261 of the 280 (93%) participants in the white light group and 255 of the 271 (94%) participants in the fluorescence group. Median follow-up in the white light and fluorescence groups were 53.0 and 55.1 months, respectively. In the white light and fluorescence groups, 83 (31.8%) and 97 (38%) of the participants remained tumor free, respectively. The median recurrence free survival was 9.6 months in the white light group and 16.4 months in the fluorescence group, p = 0.04. The rates of intravesical therapy were similar in the white light (46%) and fluorescence groups (45%). Cystectomy was performed in 22/280 (7.9%) in the white light group and 13/271 (4.8%) in the fluorescence group, p = 0.16. Conclusions Hexaminolevulinate fluorescence cystoscopy significantly improves long-term bladder cancer recurrence free survival with a trend towards improved bladder preservation.
ObjectiveThe objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations.Patients and methodsMen aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Qmax) ≤15 mL/s, and prostate volume 20–120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months.ResultsLUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen.ConclusionThe Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years.
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