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Ashish M. Kamat, MD, from MD Anderson Cancer Center, discusses enhancing clinical trial recruitment through a novel definition of BCG therapy failure in patients with nonmuscle invasive bladder cancer.
Ashish M. Kamat, MD, associate professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, discusses enhancing clinical trial recruitment through a novel definition of bacillus Calmette-Guérin (BCG) therapy failure in patients with nonmuscle invasive bladder cancer (NMIBC).
The investigation of new treatments for NMIBC is hampered by low clinical trial enrollment. Furthermore, designing a clinical trial after BCG treatment failure is complicated by a lack of an adequate or ethical control arm.
In a prospective study, the Urovysion FISH assay was performed during the course of BCG treatment to detect molecular progression prior to treatment failure by cystoscopy. In some cases, molecular BCG failure was detected after 6 weeks of treatment.
This early detection system provides an opportunity to conduct clinical trials with maintenance BCG as the control before full treatment failure by cystoscopy, Kamat explains. More importantly, he adds, this approach would negate any ethical concerns associated with an adequate control arm in post-BCG failure studies.