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

2025

Effect of Delaying 5-ALA Administration on Bladder Cancer Diagnosis

Sample size: 161 publication 10 minutes Evidence: high

Author Information

Author(s): Taoka Rikiya, Fukuhara Hideo, Miyake Makito, Kobayashi Keita, Ikeda Atsushi, Kanao Kent, Komai Yoshinobu, Fujiwara Ryo, Sato Yusuke, Sugimoto Mikio, Tsuzuki Toyonori, Fujimoto Kiyohide, Inoue Keiji, Oya Mototsugu

Primary Institution: Kagawa University Hospital

Hypothesis

Does extending the period from oral administration of 5-ALA to photodynamic diagnosis improve diagnostic accuracy and safety for non-muscle invasive bladder cancer?

Conclusion

Extending the administration period of 5-ALA to 4–8 hours before diagnosis maintains high sensitivity and acceptable safety for non-muscle invasive bladder cancer.

Supporting Evidence

BL-sensitivity was 95.3%, exceeding the non-inferiority threshold of 70%.
Sensitivity and specificity were significantly higher and lower for BL than WL, respectively.
93.8% of patients experienced adverse events, mostly grade 1 or 2.
The study included 161 patients from eight hospitals.
BL-sensitivity for flat NMIBC was significantly higher than WL-sensitivity.

Takeaway

This study shows that waiting longer after taking a medicine called 5-ALA before checking for bladder cancer can still work well and is safe.

Methodology

This was a single-arm, phase III, multicenter trial evaluating the diagnostic accuracy and safety of photodynamic diagnosis at an extended administration period of 4–8 hours after 5-ALA administration.