title: Detection and clinical outcome of urinary bladder cancer with 5-aminolevulinic acid-induced fluorescence cystoscopy : A multicenter randomized, double-blind, placebo-controlled trial.
abstract: 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) intravesically 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.
authors.affiliation: Medical Center of Eberhard Karls University, Department of Urology, Tübingen, Germany. Urologie@med.uni-tuebingen.de
authors.forename: Arnulf
authors.initials: A
authors.lastname: Stenzl
authors.forename: Hannes
authors.initials: H
authors.lastname: Penkoff
authors.forename: Elfriede
authors.initials: E
authors.lastname: Dajc-Sommerer
authors.forename: Andreas
authors.initials: A
authors.lastname: Zumbraegel
authors.forename: Lorenz
authors.initials: L
authors.lastname: Hoeltl
authors.forename: Michael
authors.initials: M
authors.lastname: Scholz
authors.forename: Claus
authors.initials: C
authors.lastname: Riedl
authors.forename: Josef
authors.initials: J
authors.lastname: Bugelnig
authors.forename: Alfred
authors.initials: A
authors.lastname: Hobisch
authors.forename: Maximilian
authors.initials: M
authors.lastname: Burger
authors.forename: Gregor
authors.initials: G
authors.lastname: Mikuz
authors.forename: Uwe
authors.initials: U
authors.lastname: Pichlmeier
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D000465:Algorithms; D000622:Aminolevulinic Acid / Q000008:administration & dosage / Q000009:adverse effects; D002277:Carcinoma / Q000175:diagnosis* / Q000601:surgery; D003558:Cystoscopy / Q000009:adverse effects / Q000379:methods*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005453:Fluorescence; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011379:Prognosis; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000601:surgery
chemical_list: D010919:Placebos; D000622:Aminolevulinic Acid