Detection and Clinical Outcome of Urinary Bladder Cancer With 5-Aminolevulinic Acid-Induced Fluorescence Cystoscopy A Multicenter Randomized, Double-Blind, Placebo-Controlled Trial

BACKGROUND: The medical community lacks results from prospective controlled multicenter studies of the diagnostic efficacy of 5-aminolevulinic acid (5-ALA) cystoscopy on tumor recurrence in patients with superficial bladder tumors. METHODS: A prospective randomized, double-blind, placebo-controlled study was conducted in 370 patients with nonmuscle-invasive urinary bladder carcinoma who received either 5-ALA (n = 187) or a placebo (n = 183) intra-vesically before cystoscopy. Each group underwent cystoscopy under visible white light and under fluorescent light followed by transurethral tumor resection. The primary study objective was to evaluate the 12-month recurrence-free survival. RESULTS: Slightly more patients with tumors were detected by using 5-ALA than by using the placebo (88.5% vs 84.7%). The mean numbers of tumor specimens per patient were 1.8 (5-ALA) and 1.6 (placebo). Intrapatient comparison of fluorescent light versus white light cystoscopy in patients randomized to receive 5-ALA showed a higher tumor detection rate with fluorescent light than with white light cystoscopy. In patients receiving 5-ALA cystoscopy, the percentage of lesions that would not have been detected in these patients by white light cystoscopy ranged between 10.9% (pT1) and 55.9% (atypia). Progression-free survival was 89.4% (5-ALA) and 89.0% (placebo) (P=.9101), and recurrence-free survival 12 months after tumor resection was 64.0% (5-ALA) and 72.8% (placebo) (P=.2216). CONCLUSIONS: In comparison to the placebo, 5-ALA cystoscopy did not increase the rates of recurrence-free or progression-free survival 12 months after tumor resection. Although more tumors per patient were detected in the 5-ALA group, the higher detection rate did not translate into differences in long-term outcome. Cancer 2011;117:938-47. (C) 2010 American Cancer Society