Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to avoid secondary resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)
Key facts
- Where
- Rome, OlaszországSee the site
- Phase
- 4. fázis
Where in Olaszország
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universita' Degli Studi Di Roma La Sapienza
- Trial code
- EU 2023-507307-64-00
- Record updated
- 2024. február 20.
- Original description
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).Read full original descriptionShow less
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
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).
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; 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.
Exclusion: 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.