Perspectives on Clinical Trial Design in NMIBC - Ashish Kamat

October 12, 2017

(Length of discussion - 7 minutes)

Ashish Kamat presents on perspectives in clinical trials in non-muscle invasive bladder cancer (NMIBC). He highlights some challenges FDA approved drugs face from trial to trial depending on the grading system used. He reflects on the difficulty that arises when comparing across different studies because of various grading systems and risk stratification standards from the European Association of Urology (EUA) vs the American Urological Association (AUA). 

Ashish Kamat reviews bacillus Calmette-Guérin (BCG) Failure and uses the example of Diagnostic/Surveillance Cystoscopy for patients in which regular white light cystoscopy was performed vs blue light cystoscopy and how comparing between trials allowing one or the other would raise these confounding factors.  He concludes with the timing of BCG treatment factors and notes the importance of considering maintenance vs induction treatment and how initial treatment can show BCG failure much sooner than it should.

Blue Light Cystoscopy with Cysview® (hexaminolevulinate HCl) is now approved for surveillance (approval: February 2018)


Ashish Kamat, MD, MBBS is a Professor of Urology and Wayne B. Duddleston Professor of Cancer Research at MD Anderson Cancer Center in Houston, Texas. Dr. Kamat serves as; President of International Bladder Cancer Group, Co-President of International Bladder Cancer Network, and Associate Cancer Center Director. Dr. Kamat served as the Program Director, of the MD Anderson Urologic Oncology Fellowship from 2005-2016.

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Definitions, End Points, and Clinical Trial Designs for Non–Muscle-Invasive Bladder Cancer: Recommendations From the International Bladder Cancer Group
Myths and Mysteries Surrounding Adjuvant Therapy for NMIBC - Ashish Kamat
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