Single, early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403): a multicentre, open-label, randomised, phase 3 trial.

Of 348 patients who had a radical nephroureterectomy, 153 were randomly assigned to the pirarubicin group and 151 to the observation group at second registration.

226 (74%) patients were male and 78 (26%) were female.

The most common grade 3-4 adverse event was haematuria, which occurred in four (3%) patients in the pirarubicin group and none in the observation group.

No treatment-related serious adverse events or deaths were observed.