Clinical trial NCT02886026: Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors
Official title: Is Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors (LMD-BT) as Good as Conventional Inpatient PDD Guided Transurethral Tumor Resection in Patients With Low Grade Non-invasive (Ta) Bladder Tumors?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Keywords: Laser
Bladder cancer
Treatment
Outpatient
TUR-BT
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compare the efficacy of conventional photodynamic (PDD) guided transurethral bladder tumor resection in the operating theatre with outpatient PDD guided laser destruction of bladder tumors through flexible cystoscopes.

Detailed description: A prospective randomized two-part clinical trial comprising patients with recurrent pTa low grade bladder tumors.

Study objectives and purpose:

* 1st Objective: To evaluate whether small pTa bladder tumours can be removed with diode laser in an outpatient department with similar efficacy as by TUR-BT resection in the operating theatre.
* 2nd Objective: To evaluate the patients experience of symptoms during laser treatment in the outpatient department (OPD) using quality of life (QOL) questionnaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
* 3rd Objective: To evaluate whether patients prefer standard transurethral bladder tumor resection (TUR-BT) in the operating theatre (OT) or laser treatment in the OPD.
* 4th Objective: To evaluate the safety after laser treatment in the OPD.

Efficacy:

* 1st Endpoint: Proportion of patients with no tumor tissue in the bladder after 4 months and 12 months.
* 2nd Endpoint: Visual Analog Scale Score (pain evaluation) in patients having tumor removed by laser in the OPD.

General urinary problems and QOL one week after the laser treatment. The Danish validated questionnaire (QLQ- BLS24) from EORTC will be used.

* 3rd Endpoint: Patients preference for either OPD laser treatment procedure or TUR-BT in the OT as inpatient procedure.
* 4th Endpoint: Character and severity of adverse events in relation to the outpatient treatment.

Study

Inclusion criteria:

1. Ta low grade bladder tumor recurrences
2. Up to a tumor size of 1,5 cm
3. Up to 6 tumors
4. Eligible patients for TUR-BT

Exclusion criteria:

1. Patients with porphyria
2. Known hypersensitivity to Hexvix® or porfhyrins
3. Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
4. Dementia
5. Macroscopic hematuria
6. Pregnant or breast feeding women
7. Expected poor compliance estimated by the investigators
8. Patients \< 18 years
9. Patients who do not read or understand Danish

Eligibility criteria: Inclusion Criteria:

1. Ta low grade bladder tumor recurrences
2. Up to a tumor size of 1,5 cm
3. Up to 6 tumors
4. Eligible patients for TUR-BT in GA

Exclusion Criteria:

1. Patients with porphyria
2. Known hypersensitivity to Hexvix® or porfhyrins
3. Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
4. Dementia
5. Macroscopic hematuria
6. Pregnant or breast feeding women
7. Expected poor compliance estimated by the investigators
8. Patients \< 18 years
9. Patients who do not read or understand Danish

Primary outcomes:
measure: Tumor recurrence histological identified in biopsy obtained during cystoscopy
timeFrame: 4 months
Secondary outcomes:
measure: Lower urinary symptoms caused by laser treatment.
timeFrame: 2 weeks
measure: Side effects to laser treatment.
timeFrame: 2 weeks
measure: Pain during laser treatment
timeFrame: Evaluated immediately after laser treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Urological department, Frederiksberg Hospital
Study officials:
affiliation: Department of Urology, Frederiksberg hospital
name: Gregers G Hermann, DM Sc
role: PRINCIPAL_INVESTIGATOR
References: