Standardization of the evaluation and surveillance of patients with BCG unresponsive high grade non-muscle invasive bladder cancer clinical trials

Yair Lotan, Piyush Agarwal, Peter Black, Rian Dickstein, Ashish M. Kamat, Byron Lee, Vikram M. Narayan, Sima Porten, Sarah P. Psutka, Armine K. Smith, Robert S. Svatek, Stephen B. Williams, Solomon Woldu

Research output: Contribution to journalReview articlepeer-review


There are multiple ongoing and planned clinical trials that are evaluating novel therapies to treat patients with BCG-unresponsive high grade nonmuscle invasive bladder cancer (NMIBC). Importantly, there is considerable variation in surveillance strategies between these clinical trials, specifically with regards to the use of advanced imaging, enhanced cystoscopy, and mandatory biopsies, which could impact landmark efficacy assessments of investigational agents. To present guideline recommendations for the standardization of cystoscopic evaluation, surveillance, and efficacy assessments for patients with BCG-unresponsive NMIBC participating in clinical trials. On September 29, 2023 at the annual meeting of the International Bladder Cancer Network, a breakout session was convened, during which representatives from various disciplines discussed potential guidance statements with opportunity for discussion and comment. A set of statements regarding use of white light and enhanced cystoscopy were developed to help guide a pragmatic approach to surveillance and efficacy assessments of patients in clinical trials. The use of “for cause” and “mandatory” biopsies was also addressed. A standard approach to evaluation of patients within the context of clinical trials is necessary to accurately assess the efficacy of novel agents, especially within single arm trials that lack an appropriate comparator. Additionally, the utilization and timing of mandatory biopsies is critical, as these biopsies may impact both disease evaluations and the determination of duration of response.

Original languageEnglish (US)
Pages (from-to)223-228
Number of pages6
JournalUrologic Oncology: Seminars and Original Investigations
Issue number8
StateAccepted/In press - 2024
Externally publishedYes


  • BCG unresponsive
  • Clinical trials
  • Mandatory biopsy
  • Surveillance

ASJC Scopus subject areas

  • Urology
  • Oncology


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