Cysview (hexaminolevulinate)

P4, N=327, Not yet recruiting, University of Roma La Sapienza | Trial primary completion date: Jul 2027 --> Dec 2027

P3; N=200; Not yet recruiting; Sponsor:Johns Hopkins University

P3, N=158, Completed, Photocure | Active, not recruiting --> Completed | N=380 --> 158

Recurrence rate was 33.3% in the primary arm and 37.5% in the secondary arm after 24 months of follow-up. Our data confirm that blue light TURBT with HAL provides superior detection and diagnosis of CIS in patients with previous white light cystoscopy.

We assessed overall costs for two approaches for removal of bladder tumours in noninvasive cancer and measured quality-adjusted life years gained for each. We found that use of a photosensitiser in the bladder was not more cost effective than use of white light only during tumour removal.

P3, N=380, Active, not recruiting, Photocure | Recruiting --> Active, not recruiting

In this study from an equal access setting in the VA, we observed significantly decreased recurrence risk and prolonged time interval to recurrence following BLC vs. WLC alone. There was no difference in bladder cancer outcomes by race.

In conclusion, our study demonstrated treatment effects with indications of systemic immune activation at diagnostic doses of HAL and blue light. The observed treatment effect seemed to be enhanced when used in combination with intravesically administrated immune checkpoint inhibitor.