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EAU 2025

EAU 2025: Diagnostic Accuracy and Efficacy of Photodynamic Diagnosis 4-8 Hours After 5-Aminolevulinic Acid Hydrochloride Administration for Non-Muscle Invasive Bladder Cancer: An Exploratory Analysis of the Phase III SPP2C102 Trial

(UroToday.com) The 2025 European Association of Urology (EAU) Annual Congress held in Madrid, Spain was host to an abstract session on the latest advances in the diagnosis and follow-up of non-muscle invasive bladder cancer (NMIBC). Dr. Rikiya Taoka presented the results of an exploratory analysis of the phase III SPP2C102 trial evaluating the diagnostic accuracy and efficacy of photodynamic diagnosis (PDD) 4–8 hours after 5-aminolevulinic acid hydrochloride (5-ALA) administration for NMIBC.


The use of PDD with 5-ALA, administered 2 to 4 hours prior to transurethral resection of bladder tumors (TURBT), has been demonstrated to have a higher sensitivity compared to white light (WL) imaging for detecting NMIBC, particularly CIS. The prospective phase III SPP2C102 study (jRCT2061210055) demonstrated that the sensitivity of PDD for detecting pathologically positive tumors was maintained when the interval between oral 5-ALA administration and TURBTs was maintained between 4 and 8 hours.1

However, PDD has potential limitations, such as tangential false-positive fluorescence results, which may lead to a variable diagnostic accuracy, depending on the tumor location. In addition, the evidence for PDD's diagnostic ability relies on studies focusing on individual tumors, and the benefits to individual patients remain unclear. The objective of this study was to determine the diagnostic accuracy of PDD with 5-ALA for specific anatomical sites and tumor types and the potential patient benefits through tumor- and subject-based analyses.

This study utilized data from the SPP2C102 trial and analyzed 1,242 specimens, including 337 histological NMIBC specimens collected from 127 patients with NMIBC and 17 non-cancer patients who received 5- ALA orally 4–8 hours prior to biopsy. The diagnostic accuracy and efficacy of blue light (BL) during TURBT were compared to WL through tumor- and subject-based analyses.

The overall sensitivity of BL imaging was 95.3%, which was significantly higher than that of WL imaging (61.1%), and similar to that previously reported.1 Significantly, the sensitivity of BL imaging exceeded 90% in all the bladder anatomical locations, except the bladder neck, and was significantly higher than that of WL imaging in all locations.

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The sensitivity of BL imaging was non-inferior to that of WL imaging for detecting papillary tumors. Furthermore, the sensitivity of BL imaging for flat tumors was superior to that of WL imaging in all locations. The positive predictive values for WL-negative/BL-positive bladder wall lesions in different locations were highly variable and ranged from 9.9% for the prostatic urethra to 43.2% for the posterior wall. As a result, subject-based analysis revealed that WL alone failed to diagnose NMIBC in 4.7% of patients, while BL missed 1.6%.

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Adding BL to WL led to an upgrade of NMIBC risk classification in 12 of 127 patients (9.4%), including 5 who were upgraded to the high-risk and 4 to the highest-risk categories.

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Dr. Taoka concluded as follows:

  • The overall sensitivity of BL imaging was 95.3%, which is significantly higher than that of WL imaging (61.1%).
  • The sensitivity of BL imaging exceeded 90% in all anatomical locations of the bladder, except the bladder neck, and was significantly higher than that of WL imaging in all locations.
  • The sensitivity of BL imaging was non-inferior to that of WL imaging for detecting papillary tumors, except in the bladder neck; furthermore, the sensitivity of BL imaging for flat tumors was superior to that of WL imaging in all locations.
  • Subject-based analysis revealed that WL alone failed to diagnose NMIBC in 4.7% of patients, while BL missed 1.6%.
  • Adding BL to WL led to an upgrade of NMIBC risk classification scores in 12 of 127 patients (9.4%).

Presented by: Rikiya Taoka, MD, PhD, Department of Urology, Kagawa University, Kagawa, Japan

Written by: Rashid K. Sayyid, MD, MSc – Robotic Urologic Oncology Fellow at The University of Southern California, @rksayyid on Twitter during the 2025 European Association of Urology (EAU) Annual Meeting held in Madrid, Spain between March 21st and 24th 2025 

References:

  1. Taoka R, Fukuhara H, Miyake M, et al. Effect of extending the period from oral administration of 5-aminolevulinic acid hydrochloride to photodynamic diagnosis during transurethral resection for non-muscle invasive bladder cancer on diagnostic accuracy and safety: a single-arm multicenter phase III trial. Int J Clin Oncol. 2025; 30(1):110-20.