Hexaminolevulinate for Non-muscle invasive bladder cancer

Inclusion criteria

• {"criterion_text":"- Voluntarily signed informed consent per Good Clinical Practice and national regulations\n- Age ≥ 18 years\n- Patient planned for TURB for >1,5 cm suspected (with either abdomen ultrasound or flexible cystoscopy) primary bladder cancer. The cut-off of 1,5cm has been chosen to maximize the probability of enrolling high-risk patients and, consequently, to maximize the probability of performing the re-TURB."}

Exclusion criteria

• {"criterion_text":"- Patients with history of recurrent NMIBC\n- Patients with visible incomplete resection during primary TURB.\n- Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC.\n- Allergy to hexaminolevulinate hydrochloride or any of the ingredients listed in Smpc of the product.\n- Previous diagnosis of porphyria.\n- Diagnosis of from gross haematuria or blood in the urine.\n- Diagnosis of bladder inflammation, a recent urinary tract infection.\n- Pregnancy and breastfeeding"}

Primary endpoints

• {"endpoint_text":"- proportion of patients with residual tumour and/or new diagnosis of CIS at the time of reTUR (persistent CIS diagnosed at primary TUR will not count as residual tumour) in comparison between PDD and WLC","definition_or_measurement_approach":"Measured as the proportion of patients with residual tumour and/or new diagnosis of carcinoma in situ (CIS) at the time of re-TUR; persistent CIS diagnosed at primary TUR is not counted as residual tumour. Comparison performed between PDD and WLC arms."}

Secondary endpoints

• {"endpoint_text":"- proportion of CIS and upstaging according to the definition by Lamm et al. at re-TUR","definition_or_measurement_approach":"Measured as proportion of CIS and upstaging at re-TUR using the definition by Lamm et al."}
• {"endpoint_text":"- comparative 3-months recurrence rate for patients not undergoing reTUR.","definition_or_measurement_approach":"Measured as recurrence rate at 3 months for patients who do not undergo re-TUR."}
• {"endpoint_text":"- proportion of malignant lesions at primary TURB and re-TURB between PDD and WLC utilising high-definition equipment.","definition_or_measurement_approach":"Measured as proportion of malignant lesions detected at primary TURB and at re-TURB, comparing PDD and WLC, using high-definition equipment."}
• {"endpoint_text":"- Proportion of patients with treatment change as a result of additional tumour findings at re-TUR.","definition_or_measurement_approach":"Measured as proportion of patients whose treatment plan changed due to additional tumour findings at re-TUR."}
• {"endpoint_text":"- Quality of life estimated with EQ5DL and the QLQ-NMIBC24 questionnaires performed at the following timepoints: after randomization, 1 month after 1st TURB, 3 months after Re-TURBT for all groups","definition_or_measurement_approach":"Quality of life measured using EQ-5D-5L and QLQ-NMIBC24 questionnaires at specified timepoints: after randomization, 1 month after first TURB, and 3 months after re-TURBT."}
• {"endpoint_text":"- Adverse events","definition_or_measurement_approach":"Captured and reported adverse events (standard safety reporting); no further detailed measurement approach provided in the record."}

Italy

Earliest CTIS Part Ii Submission Date

19-04-2025

Latest Decision Or Authorization Date

19-05-2025

Processing Time Days

30

Number Of Sites

1

Number Of Participants

300

Primary sponsor

Full Name

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Photocure","duties_or_roles":"Source of monetary support","organisation_type":""}