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Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to avoid secondary resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)
EU CTIS ID: 2023-507307-64-00
What this study is testing
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).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Contraindication to TURBT and/or Re-TURBT
- 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).
- 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)
See the full eligibility criteria
- 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
- Contraindication to TURBT and/or Re-TURBT
- 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).
- 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)
- Concomitant Upper tract (kidney or ureteric) tumours on imaging
- Contraindication to adjuvant intravesical BCG immunotherapy
- Unfit to undergo any procedures listed in protocol
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.