Status:
RECRUITING
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)
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Non-muscle-invasive Bladder Cancer
Non-Muscle Invasive Bladder Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT...
Detailed Description
BACKGROUND, STATE OF THE ART and RATIONALE FOR THE INTERVENTIONS The vast majority (75-80%) of bladder cancers (BCa) patients present with disease confined either to the mucosa (stage Ta, carcinoma i...
Eligibility Criteria
Inclusion
- 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.
- Patients with a TUR-confirmed diagnosis of NMIBC and candidate for second look and resection (Re-TURBT) according to EAU Guidelines \[6\].
- 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).
- Patients who did or did not receive previous BCG immunotherapy (i.e., BCG naïve and non-naïve patients).
- Fit to undergo all procedures listed in protocol.
- Able to provide written informed consent.
Exclusion
- Contraindication to TURBT and/or Re-TURBT.
- Initial TURBT diagnosis of MIBC (i.e., T2) or locally advanced BCa (i.e., T3-T4).
- Preoperative evidence of metastatic disease (i.e., cN1 - N3 and/or cM1).
- Visual evidence of low-risk NMIBC (solitary tumor, \< 1 cm) before initial TURBT.
- Visual evidence of MIBC on preliminary cystoscopy (i.e., non-papillary or sessile mass attached directly by its base without a stalk).
- 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) \[6\].
- Concomitant Upper tract (kidney or ureteric) tumours on imaging.
- Contraindication to adjuvant intravesical BCG immunotherapy.
- Unfit to undergo any procedures listed in protocol.
Key Trial Info
Start Date :
December 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT05962541
Start Date
December 22 2025
End Date
December 1 2031
Last Update
December 31 2025
Active Locations (1)
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1
AOU Policlinico Umberto I Hospital, UOC Urologia SMUC05, Rome, Italy
Rome, Lazio, Italy, 00161