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2023-507307-64-00RecruitingPhase 4

Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to avoid secondary resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
258 (estimated)
First submitted
22 Oct 2023
Start date
22 Dec 2025
Lead sponsor
Universita' Degli Studi Di Roma La Sapienza
EU CT number
2023-507307-64-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 258
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant Upper tract (kidney or ureteric) tumours on imaging
  • Contraindication to adjuvant intravesical BCG immunotherapy

Other illness

  • 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).

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Azienda Ospedaliero-Universitaria Policlinico Umberto IRomeItalyRecruiting

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