Under construction – not a live service
Sign in
Taking people in ItalyPhase 4

Light-guided bladder tumour removal to avoid a repeat operation

Tests light-guided surgery without a repeat operation in bladder cancer.

Key facts

Who runs it
Universita' Degli Studi Di Roma La Sapienza
Where
Rome, ItalySee the site
Registry title
Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to avoid secondary resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)
Status
Recruiting
Phase
Phase 4
People taking part
258 people, planned
Started
22 Dec 2025
Expected to end
31 Jul 2027
Type of study
Interventional
Record updated
20 February 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with non-muscle invasive bladder cancer who would normally need a second bladder resection. It compares a light-guided first operation with the usual first operation plus a repeat.

Age
18 years or older
Sex
Women and men can both join.
Disease stage
Non-muscle invasive bladder cancer confirmed by the first resection and due for a repeat resection under the EAU Guidelines. Only CIS, Ta, T1, N0, M0 disease counts. Scans must show no muscle-invasive, locally advanced or spread cancer (mpMRI/VI-RADS score 1 or 2).
Earlier treatment
People must never have had BCG immunotherapy in the bladder (BCG naive).

Main reasons for not taking part

  • Cancer that has grown into the bladder muscle (T2) or beyond (T3-T4), or has spread (cN1-N3 and/or cM1)
  • Low-risk bladder cancer before the first resection: a single tumour and/or smaller than 1 cm (0.4 in)
  • Cancer type that does not need a repeat resection under the EAU Guidelines (Ta-LG; Ta-HG with detrusor muscle in the specimen; primary CIS)
  • Tumour in the kidney or ureter seen on imaging
  • Cannot have the operations or BCG treatment

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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
  • 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 never received adjuvant Bacillus of Calmette-Guérin (BCG) immunotherapy (i.e., BCG naïve patients) for previous BCa history
  • Fit to undergo all procedures listed in protocol
  • Able to provide written informed consent

Who cannot take part

  • Concomitant Upper tract (kidney or ureteric) tumours on imaging
  • Contraindication to adjuvant intravesical BCG immunotherapy
  • Initial TURBT diagnosis of Muscle-Invasive Bladder Cancer (MIBC, i.e., T2) or locally advanced BCa (i.e., T3-T4)
  • Preoperative evidence of metastatic disease (i.e., cN1 – N3 and/or cM1)
  • Contraindication to TURBT and/or Re-TURBT
  • Visual evidence of low-risk NMIBC (solitary tumor and/or < 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)
  • Unfit to undergo any procedures listed in protocol

Where in Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people

About the trial

What the trial wants to find out

To leverage our expertise in Bladder Cancer (BCa)intraoperative Trans-Uretrhal Resection of Bladder Tumor (TURBT), optical imaging enhancement by photodynamic (PDD)-guided resection, and clinical practice shift to improve the therapeutic algorithm and personalization of Non-muscle Invasive Bladder Cancers (NMIBCs). We aim to provide the highest level of evidence for re-defining European Association of Urology (EAU) Guidelines selecting criteria among NMIBCs who could safely avoid unjustified and unnecessary secondary resection (Re-TURBT) procedures. We intend to demonstrate how our experimental multidisciplinary approach will be not oncological inferior to the current standard of care algorithm thus justifying a paradigmatic shift towards a potentially more sustainable and cost-effective patient-tailored surgical approach in NMIBCs candidate for second look and resection (Re-TURBT). To this purpose, in a homogeneous cohort of pre-operative selected patients, we will determine the proportion of early BCa recurrences (i.e., within 4.5 months follow-up) in those NMIBC treated by standard of care (i.e., TURBT followed by Re-TURBT) compared to our novel algorithm proposal (i.e., primary PDD-TURBT followed by no Re-TURBT).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of primary Photodynamic Trans-urethral Resection of Bladder Tumors (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
Plain-language title
Light-guided bladder tumour removal to avoid a repeat operationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
20 February 2024