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Updated: Jul 4, 2025

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A Randomized Trial of PHOTOdynamic Surgery in Non-Muscle-Invasive Bladder Cancer.

Rakesh Heer1, Rebecca Lewis2, Thenmalar Vadiveloo3

  • 1Newcastle University, Newcastle upon Tyne, United Kingdom.

NEJM Evidence
|February 6, 2024
PubMed
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Photodynamic diagnosis (PDD)-guided transurethral resection of bladder tumor (TURBT) did not significantly reduce non-muscle-invasive bladder cancer recurrence rates compared to standard white light (WL) TURBT over three years. The PDD approach was also not found to be more cost-effective.

Area of Science:

  • Urology
  • Oncology
  • Medical Technology Assessment

Background:

  • Non-muscle-invasive bladder cancer (NMIBC) recurrence is common after transurethral resection of bladder tumor (TURBT).
  • Photodynamic diagnosis (PDD) aims to improve diagnostic accuracy and resection completeness, potentially reducing NMIBC recurrence.
  • Limited data exists on the long-term clinical and cost-effectiveness of PDD-guided TURBT.

Purpose of the Study:

  • To evaluate the clinical effectiveness of PDD-guided TURBT versus standard white light (WL)-guided TURBT in reducing NMIBC recurrence.
  • To assess the cost-effectiveness of PDD-guided TURBT compared to WL-guided TURBT over a 3-year follow-up period.

Main Methods:

  • A pragmatic, open-label, parallel-group randomized trial involving 22 UK hospitals.

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  • Participants with suspected first-time NMIBC at intermediate or high risk for recurrence were randomized (1:1) to PDD-guided TURBT or WL-guided TURBT.
  • The primary outcome was time to recurrence at 3 years, with secondary analyses of cost-effectiveness and quality of life.

    • Main Results:

    • After a median follow-up of 44 months, no significant difference in recurrence rates was observed between the PDD and WL groups (HR 0.94; P=0.70).
    • Three-year recurrence-free rates were 57.8% for PDD and 61.6% for WL, with an absolute difference of -3.8% (favoring PDD, but not statistically significant).
    • PDD-guided TURBT incurred an additional cost of £876 over 3 years with no significant difference in quality-adjusted life years.

    Conclusions:

    • PDD-guided TURBT did not demonstrate a significant reduction in NMIBC recurrence rates compared to standard WL-guided TURBT at the 3-year follow-up.
    • The PDD approach was not found to be more cost-effective than WL-guided TURBT within the study period.
    • Further research may be needed to explore potential benefits or specific patient subgroups where PDD might offer advantages.