Fluorescence ureteroscopy-assisted transurethral surgery with oral 5-aminolevulinic acid for upper urinary tract tumor

JRCT ID: jRCTs051210042

Registered date:28/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Localized upper urinary tract cancer (renal pelvic cancer and ureteral cancer)
• Date of first enrollment: 28/06/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Oral administration of 5-aminolevulinic acid hydrochloride

Outcome(s)

Primary Outcome

Progression-free survival
Definition of progression: patients experience any of the following events
A. Imaging with CT scan or MRI reveals local progression or distant metastasis (event occurrence date:
date of the imaging)
B. The principal investigator or the subinvestigators judge that ureteroscopic treatment cannot be
completed in the follow-up photodynamic diagnosis-assisited ureteroscopy (event occurrence date:
date of the ureteroscopy)

Secondary Outcome

1) Recurrence-free survival (intravesical recurrence-free survival and upper urinary tract recurrence-free
survival)
2) Time to salvage radical nephroureterectomy
3) Cancer-specific survival
4) Overall survival
5) Postoperative change of health-related quality of life (evaluation with SF-8 , EORTC QLQ-C30,
FACT-BL): before treatment, 1, 3, 6, 9, 12, 18, and 24 months after treatment
6) Postoperative change of lower urinary tract symptoms (evaluation with IPSS and OABSS): before treatment, 1, 3, 6, 9, 12, 18, and 24 months after treatment
7) Rate of adverse events (evaluation with CTCAE ver 5)
8) Diagnostic accuracy of urine cytology and UroVision test of voiding urine specimens during follow-up
9) Diagnostic accuracy of urine cytology and UroVision test of urine specimens obtained by ureteroscopy
during follow-up
10) Safety of 5-aminolevulinic acid hydrochloride

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with clinical Ta-1N0M0 localized upper urinary tract cancer desire kidney-preservation therapy and meet any of the following A to E.
A. Tumor develops in patients with solitary kidney or tumor develops bilaterally.
B. Patients with chronic kidney disease are expected to avoid renal replacement therapy in the future by
kidney-preservation therapy.
C. Due to poor performance status, it is clinically judged that total nephroureterectomy is not indicated.
D. Patients have a single tumor with a major axis of 10 mm or less and have a healthy kidney on the
contralateral side.
E. Patients desire kidney-preservation therapy although they are recommended radical
nephroureterectomy.
2) Age, 20 years or older (Regardless of gender)
3) The pathological diagnosis is confirmed by ureteroscopic biopsy or urine cytology.
4) The name and condition of the disease have been announced to the patient, and he / she must be given an explanation when participating in this study. The written consent at his / her will must be obtained with
sufficient understanding.
5) Bone marrow function and organ function (excluding renal function) are sufficient within 60 days before
registration.

Exclude criteria

1) Patients with a history of allergic reaction to 5-aminolevulinic acid.
2) Pregnant women, lactating women and patients who may be pregnant.
3) Cases with liver dysfunction and inflammatory disease.
4) Patients with porphyria or patients with a history of allergic reaction to porphyrin-related substances.
5) Cases in which you cannot consent or take the medicine on your own initiative.
6) Inappropriate for the enrolment by the judgement of the physician.

Related Information

• Primary Sponsor: Miyake Makito