Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)

Launched by UNIVERSITY OF ROMA LA SAPIENZA · Jul 24, 2023

Keywords

ClinConnect Summary

This clinical trial, called the CUT-less trial, is studying a new approach to treating non-muscle-invasive bladder cancer (NMIBC). Typically, patients with this condition undergo a procedure to remove the tumor (called TURBT) and may need a second procedure (Re-TURBT) to ensure all cancer is gone. However, this second surgery isn't always necessary. The trial aims to see if a new imaging technique, called VI-RADS, combined with a special method of tumor removal using photodynamic diagnosis (PDD), can safely reduce the need for Re-TURBT. This method uses special light to help doctors see tumors that might be missed with standard lighting.

To be eligible for this trial, participants must be at least 18 years old with a confirmed diagnosis of NMIBC and no signs of muscle invasion or metastasis (spread to other areas). They should be fit for the procedures and able to give consent. If you join the trial, you'll be randomly assigned to either receive the new PDD-TURBT without needing a second surgery or the standard treatment with the possibility of a second surgery. The trial will look at how well these approaches work in terms of cancer recurrence and also consider how they impact patients' quality of life and healthcare costs. This research could lead to more personalized and less invasive treatments for bladder cancer, benefiting both patients and the healthcare system.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Female and Male patients at least 18 years old referred for clinical suspicion of primary or recurrent BCa who have been advised to undergo TURBT.
• • 2. Patients with a TUR-confirmed diagnosis of NMIBC and candidate for second look and resection (Re-TURBT) according to EAU Guidelines \[6\].
• • 3. No imaging evidence (i.e., mpMRI/VI-RADS score 1 or 2) of muscle-invasive, locally advanced, or metastatic BCa (i.e., only confirmed CIS, Ta, T1, N0, M0 will be considered eligible).
• • 4. Patients who did or did not receive previous BCG immunotherapy (i.e., BCG naïve and non-naïve patients).
• • 5. Fit to undergo all procedures listed in protocol.
• • 6. Able to provide written informed consent.
• Exclusion Criteria:
• • 1. Contraindication to TURBT and/or Re-TURBT.
• • 2. Initial TURBT diagnosis of MIBC (i.e., T2) or locally advanced BCa (i.e., T3-T4).
• • 3. Preoperative evidence of metastatic disease (i.e., cN1 - N3 and/or cM1).
• • 4. Visual evidence of low-risk NMIBC (solitary tumor, \< 1 cm) before initial TURBT.
• • 5. Visual evidence of MIBC on preliminary cystoscopy (i.e., non-papillary or sessile mass attached directly by its base without a stalk).
• • 6. TURBT diagnosis of NMIBCs not eligible for Re-TURBT according to EAU Guidelines (i.e., Ta-LG; Ta-HG with detrusor muscle in the specimen; primary CIS) \[6\].
• • 7. Concomitant Upper tract (kidney or ureteric) tumours on imaging.
• • 8. Contraindication to adjuvant intravesical BCG immunotherapy.
• • 9. Unfit to undergo any procedures listed in protocol.