Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
300
Countries
1
Sites
1
Not muscular invasive bladder cancer
Primary objective is to compare the completeness of TURB with PDD vs TURB with WL in terms of proportion of patients with residual disease and/or upstaging at re-TURB.
Key facts
- Sponsor
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-05-19
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Photocure
External identifiers
- EU CT number
- 2024-514316-27-00
- ClinicalTrials.gov
- NCT06548438
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Primary objective is to compare the completeness of TURB with PDD vs TURB with WL in terms of proportion of patients with residual disease and/or upstaging at re-TURB.
Secondary objectives 3
- To compare the detection of malignant lesions between PDD and WLC using high-definition (HD) equipment during both primary TURB and re-TURB
- To compare quality of life of patients after treatment
- To assess treatment changes and adverse events associated with each technique
Conditions and MedDRA coding
Not muscular invasive bladder cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10005003 | Bladder cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Voluntarily signed informed consent per Good Clinical Practice and national regulations
- Age ≥ 18 years
- Patient planned for TURB for >1,5 cm suspected (with either abdomen ultrasound or flexible cystoscopy) primary bladder cancer. The cut-off of 1,5cm has been chosen to maximize the probability of enrolling high-risk patients and, consequently, to maximize the probability of performing the re-TURB.
Exclusion criteria 8
- Patients with history of recurrent NMIBC
- Patients with visible incomplete resection during primary TURB.
- Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC.
- Allergy to hexaminolevulinate hydrochloride or any of the ingredients listed in Smpc of the product.
- Previous diagnosis of porphyria.
- Diagnosis of from gross haematuria or blood in the urine.
- Diagnosis of bladder inflammation, a recent urinary tract infection.
- Pregnancy and breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- proportion of patients with residual tumour and/or new diagnosis of CIS at the time of reTUR (persistent CIS diagnosed at primary TUR will not count as residual tumour) in comparison between PDD and WLC
Secondary endpoints 6
- proportion of CIS and upstaging according to the definition by Lamm et al. at re-TUR
- comparative 3-months recurrence rate for patients not undergoing reTUR.
- proportion of malignant lesions at primary TURB and re-TURB between PDD and WLC utilising high-definition equipment.
- Proportion of patients with treatment change as a result of additional tumour findings at re-TUR.
- Quality of life estimated with EQ5DL and the QLQ-NMIBC24 questionnaires performed at the following timepoints: after randomization, 1 month after 1st TURB, 3 months after Re-TURBT for all groups
- Adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hexvix 85 mg polvere e solvente per soluzione endovescicale
PRD8623382 · Product
- Active substance
- Hexaminolevulinate
- Substance synonyms
- APL-1702
- Pharmaceutical form
- INTRAVESICAL SOLUTION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 8 mmol/l millimole(s)/litre
- Max total dose
- 16 mmol/l millimole(s)/litre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CX — OTHER DIAGNOSTIC AGENTS
- Marketing authorisation
- 037598036
- MA holder
- PHOTOCURE ASA
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
2
Total trials
Academic / Non-commercial
- Sponsor organisation
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Address
- Corso Bramante 88
- City
- Turin
- Postcode
- 10126
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Contact name
- Francesco Soria
Public contact point
- Organisation
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Contact name
- Francesco Soria
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 300 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-514316-27-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments | 1 |
| Recruitment arrangements (for publication) | K2_Case report form | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults | 1 |
| Subject information and informed consent form (for publication) | L2_GP letter | 1 |
| Subject information and informed consent form (for publication) | L2_Patients questionnaire EQ-5D-5L | 1.1 |
| Subject information and informed consent form (for publication) | L2_Patients questionnaire NMIBC24 | 1 |
| Subject information and informed consent form (for publication) | L2_privacy SIS and ICF | 1 |
| Subject information and informed consent form (for publication) | L2_SIS adults | 1 |
| Subject information and informed consent form (for publication) | L2_SIS adults_TC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Hexvix | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ 2024-514316-27-00_EN | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ 2024-514316-27-00_IT | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-29 | Italy | Acceptable 2025-05-19
|
2025-05-19 |