Clinical trial NCT06548438: The Impact of PDD During TURB for NMIBC
Official title: The Impact of PDD During TURB for NMIBC: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Bladder Cancer
Keywords: TURB
re-TURB
photodynamic diagnosis-PDD
Hexvix
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
Collaborators: name: Photocure
First posted: 2024-08-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial. Randomization will be stratified based on the dedicated surgeon performing the procedure. Allocation will be at a 1:1 ratio between the two arms
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to learn if photodynamic diagnosis (PDD) performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml) is more sensitive than the standard white light tecnique in detection of malignant bladder tumour.

Patients will be randomised to:

* Transurethral resection of the bladder (TURB) with a standard white light tecnique
* TURB with the PDD tecnique using the study drug Hexvix

Detailed description: Non-muscle invasive pT1 high-grade (HG) bladder cancer (NIMBC) represents a challenge for the urologists due to its aggressive behavior, with a marked tendency to recur after transurethral resection of the bladder (TURB) and even progress to muscle-invasive disease. To limit the risk of upstaging and to provide more clinical information indispensable for the decision-making process, international guidelines strongly recommend a re-TURB to be performed within 2-6 weeks from the first resection in all pT1HG tumors. However, not all the published literature agrees on the value of re-TURB wich is also an invasive and morbid procedure, requires a general or locoregional anesthesia and, like all surgical procedure, it is not free of risks and complications. There is, therefore, an unmet need for improving the quality and completeness of TURB which may have an impact on the necessity of Re-TURB. It has been confirmed that fluorescence-guided biopsy and resection (photodynamic diagnosis-PDD) are more sensitive than conventional procedures for the detection of malignant tumours, particularly for CIS. PDD is performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml).To date, no randomized controlled trials (RCTs) have been conducted aiming to compare the completeness of TURB with PDD compared to TURB with standard white light (WL).

Eligibility criteria: Inclusion Criteria:

* Voluntarily signed informed consent per Good Clinical Practice and national regulations
* Age ≥ 18 years
* 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:

* Patients with history of recurrent NMIBC
* Patients with visible incomplete resection during primary TURB
* Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC

Primary outcomes:
measure: Residual disease and/or upstaging
timeFrame: 6 to 8 weeks from the intervention
Secondary outcomes:
measure: Number of Participants diagnosed with malignant lesions
timeFrame: 6 to 8 weeks from the intervention
measure: The European organization for reasearch and treatment of cancer quality of life questionnaire for patients with non-muscle invasive bladder cancern
timeFrame: from date of randomization until 20 weeks from randomization
measure: EQ-5D-5L
timeFrame: from date of randomization until 20 weeks from randomization
measure: EQ VAS
timeFrame: from date of randomization until 20 weeks from randomization
measure: Adverse events
timeFrame: from date of randomization until 20 weeks from randomization
Other outcomes:
Locations:
Study officials:
affiliation: AOU Città della Salute e della Scienza
name: Francesco Soria
role: PRINCIPAL_INVESTIGATOR
References: