MRI (VI-RADS) plus photodynamic-guided TURBT to avoid routine repeat bladder resections

Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of Vesical Imaging- Reporting and Data System (VI-RADS) Followed by Primary Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) Versus Conventional White-light TURBT Plus Repeated-TURBT (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) Candidate for Second Look and Resection

This study tests whether using a preoperative MRI VI-RADS score together with photodynamic-assisted TURBT can let people with non-muscle-invasive bladder cancer safely skip a routine second resection.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 327 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Roma La Sapienza (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Rome, Lazio)
• Trial ID: NCT05962541 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional protocol enrolls adults with TUR-confirmed non‑muscle‑invasive bladder cancer who would otherwise be recommended a second-look resection. Participants receive preoperative multiparametric MRI scored with VI‑RADS and undergo primary photodynamic diagnosis (PDD)-assisted TURBT using hexaminolevulinate. Patients with low VI‑RADS (1–2) and a high-quality PDD-TURBT may avoid a planned Re‑TURBT, and outcomes such as residual tumor, recurrence, and pathological staging will be recorded. The study aims to determine whether the combined imaging-plus-PDD strategy can safely reduce unnecessary repeat resections and improve initial management.

Who should consider this trial

Good fit: Adults (≥18) with TUR-confirmed non‑muscle‑invasive bladder cancer who are candidates for Re‑TURBT per EAU guidelines, have a preoperative VI‑RADS score of 1–2, are fit for the procedures, and can provide informed consent.

Not a fit: Patients with MRI or clinical evidence of muscle‑invasive or metastatic disease (VI‑RADS ≥3), those with inadequate initial resections, or those with contraindications to TURBT/PDD are unlikely to benefit from skipping a Re‑TURBT.

Why it matters

Potential benefit: If successful, this approach could safely reduce unnecessary repeat surgeries, decreasing complication risk and healthcare costs while maintaining cancer control.

How similar studies have performed: Previous work shows VI‑RADS improves preoperative staging and PDD enhances tumor detection, but combining them specifically to omit Re‑TURBT is relatively novel and not yet widely validated.

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.

Where this trial is running

Rome, Lazio

• AOU Policlinico Umberto I Hospital, UOC Urologia SMUC05, Rome, Italy — Rome, Lazio, Italy (Recruiting)

Study contacts

• Study coordinator: Francesco Del Giudice, MD

Conditions Non-muscle-invasive Bladder Cancer; Non-Muscle Invasive Bladder Urothelial Carcinoma; High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma