The guidelines recommend kidney-sparing surgery as the primary treatment for selected patients with low-risk upper urinary tract urothelial carcinoma (UTUC). An important issue with ureteroscopic laser ablation (ULA) is the high rate of surgical-site recurrence, largely attributable to residual lesions at the initial ULA. This trial aimed to investigate the efficacy and safety of oral 5-aminolevulinic acid hydrochloride-mediated photodynamic diagnosis (ALA-PDD)-assisted ULA for UTUC.
The study evaluated 20 patients with cTa-1N0M0 UTUC who underwent ALA-PDD-assisted ULA using thulium-holmium:YAG dual lasers. The primary endpoint was the 2-year progression-free survival rate. Treatment-related adverse events (AEs), usefulness of the UroVysion test combined with conventional urinary cytology for detecting recurrent tumors, and longitudinal changes in patient-reported health-related quality of life (HRQoL) after ULA were evaluated.
Of the 20 patients, 3 (15 %) experienced disease progression, and the 2-year progression-free survival rate was 82 % (95 % confidence interval [CI], 54-93 %). The lower limit of the 95 % CI for the 2-year PFS rate was less than the prespecified threshold survival rate of 58 %. The most common AEs were transient urinary-related symptoms. No grade ≥3 AEs were observed throughout the trial. Due to the low positivity rate of pretreatment UroVysion testing, the study could not evaluate its usefulness for monitoring post-ULA recurrence. Most domains and scales of HRQoL showed acceptable changes during treatment and follow-up evaluation. In particular, the intervention positively affected mental and emotional conditions.
This study provided evidence for the potential benefits and efficacy of this treatment option for selected patients with UTUC.
Annals of surgical oncology. 2026 Mar 05 [Epub ahead of print]
Makito Miyake, Nobutaka Nishimura, Yuki Oda, Mitsuru Tomizawa, Takuto Shimizu, Takuya Owari, Daisuke Gotoh, Yoshitaka Itami, Tomonori Nakahama, Motokiyo Yoshikawa, Ken Fujimoto, Atsushi Tomioka, Satoshi Anai, Tomomi Fujii, Kiyohide Fujimoto
Department of Urology, Nara Medical University, Kashihara, Nara, Japan. ., Department of Urology, Nara Medical University, Kashihara, Nara, Japan., Department of Urology, Tane General Hospital, Osaka, Japan., Department of Urology, Hirao Hospital, Kashihara, Nara, Japan., Department of Urology, Nara Prefecture General Medical Center, Nara, Nara, Japan., Department of Urology, Okanami General Hospital, Iga, Japan., Department of Urology, Saiseikai Chuwa Hospital, Sakurai, Nara, Japan., Department of Urology, Nara Prefecture Seiwa Medical Center, Ikoma, Nara, Japan., Division of Fostering Required Medical Human Resources, Center for Infectious Disease Education and Research (CiDER), Osaka University, Osaka, Japan.