The past, present, and future of pT0 in bladder cancer clinical trials

Jared P. Schober, Elizabeth Plimack, Daniel Geynisman, Matthew Zibelman

Research output: Contribution to journalReview articlepeer-review


Purpose of reviewSince the establishment of neoadjuvant chemotherapy as the standard of care for patients with muscle invasive bladder cancer, the pathologic absence of disease, denoted pT0, was found to be predictive of improved overall survival. Accordingly, it has been used in clinical trials as an optimal surrogate outcome measure, even in contemporary nonchemotherapeutic interventions. We review the role of pT0 as a catalyst for change in trial design and its suitability to facilitate more efficient and timely results. In addition, we explore the present and future of cT0, the clinical absence of disease, in defining treatment response and enabling bladder-sparing management options.Recent findingsThe use of pT0 as a surrogate has provided initial results for the efficacy of immunotherapy in the neoadjuvant space. In combination with molecular markers, pT0 has improved our ability to identify treatment responders and its clinical counterpart, cT0, has been integrated into multiple trials to redefine postneoadjuvant chemotherapy management algorithms.SummaryThe use of pT0 as a surrogate endpoint in bladder cancer trials has improved clinical trial design, defined efficacy of emerging therapeutics, and has the potential to redefine the postneoadjuvant treatment management for patients seeking bladder-sparing options.

Original languageEnglish (US)
Pages (from-to)495-499
Number of pages5
JournalCurrent Opinion in Urology
Issue number5
StatePublished - Sep 1 2022
Externally publishedYes


  • bladder cancer
  • clinical trials
  • neoadjuvant chemotherapy
  • neoadjuvant immunotherapy
  • pT0

ASJC Scopus subject areas

  • Urology


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