Evaluation of the UroVysion™ Test to Predict Recurrence and/or Progression of Disease After BCG for Primary High Grade Non-Muscle Invasive Bladder Cancer: Results from a Prospective Multicenter Trial

ABSTRACTPurpose:Single center studies found that UroVysion FISH (UroVysion) positive results were associated with recurrence in non-muscle invasive bladder cancer (NMIBC) treated with intravesical BCG. Our goal was to validate these findings.Materials and Methods:We conducted a prospective, multicenter, diagnostic trial to determine whether UroVysion can predict recurrence or progression in patients with primary high grade NMIBC slated to receive BCG. UroVysion testing was performed prior to first instillation of BCG, prior to 6th instillation, and at 3 months cystoscopy. The performance of UroVysion was evaluated.Results:150 patients were enrolled, including 68 with Ta tumors, 41 with T1 disease, 26 with CIS alone, and 15 with papillary plus CIS. At 9 months of follow-up, there were 46 events, (37 recurrences and 9 progressions). The hazard ratio for events with positive UroVysion was 2.59 [95%CI: 1.42-4.73] for baseline test, 1.94 [95%CI: 1.04-3.59] for 6-week test, and 3.22 [95%CI: 1.65-6.27] at 3-mont...