Latest guidelines recommend kidney-sparing management as the primary treatment option for selected patients with upper urinary tract urothelial carcinoma (UTUC). One of the biggest issues of ureteroscopic laser ablation (ULA) is a high rate of surgical site recurrence, which is largely attributed to residual lesions at the initial ULA. Another clinical issue is a significant lack of non-invasive reliable detection tools of urinary recurrent tumors in this treatment setting.
The FLUAM trial is a prospective, single-center, single-arm pilot trial to investigate the efficacy of 5-aminolevulinic acid-mediated photodynamic diagnosis (ALA-PDD)-assisted ULA for localized UTUC and the usefulness of the UroVysion® assay (multiprobe fluorescence in situ hybridization) as a monitoring test after the kidney-sparing treatment. After the screening and registration, a total of 20 patients with localized UTUC will undergo the initial ALA-PDD-assisted ULA followed by the second look ALA-PDD-assisted ureteroscopic examination. The primary endpoint is progression-free survival. Secondary endpoints include patient reported outcomes, diagnostic accuracy of UroVysion assay to detect tumor recurrence, adverse events, and safety of the intervention.
The goal of this trial is to determine the potential benefit of ALA-PDD assistance in patients who undergo the ULA. The evidence of this novel technique is still limited. The results are expected to change the standard of care and lead to better management of localized UTUC.
This clinical trial was prospectively registered with the Japan Registry of Clinical Trials on 23 June 2021. The reference number is jRCTs051210042, nara0023 (Certified Review Board of Nara Medical University).
Contemporary clinical trials communications. 2022 Mar 02*** epublish ***
Makito Miyake, Takashi Yoshida, Nobutaka Nishimura, Yuki Oda, Takuto Shimizu, Tomonori Nakahama, Shunta Hori, Yosuke Morizawa, Daisuke Gotoh, Yasushi Nakai, Satoshi Anai, Kazumasa Torimoto, Tomomi Fujii, Nobumichi Tanaka, Kiyohide Fujimoto
Department of Urology, Nara Medical University, Kashihara, Nara, Japan., Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, Japan., Department of Urology, Hirao Hospital, Kashihara, Nara, Japan., Department of Diagnostic Pathology, Nara Medical University, Kashihara, Nara, Japan.