Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors (LaserIII)

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?

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: Bladder tumor resection using diathermia; Device: Diode laser (980 nm) tumor destruction

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

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregers G Hermann, DM Sc; Phone Number: +45 38163536; Email: gregersgautierhermann@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2000
    • Recruiting
    • Urological department, Frederiksberg Hospital
    • Contact: Gregers G Hermann, MD; Phone Number: + 45 38163536; Email: gregers.gautier.hermann@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inpatient TUR-BT; Transurethral bladder tumor resection in operating theatre as inpatient.	Device: Bladder tumor resection using diathermia; Conventional bladder tumor resection using diathermia
Experimental: laser bladder tumor destruction; Outpatient laser mediated destruction of bladder tumors (LMD-BT)	Device: Diode laser (980 nm) tumor destruction; Laser mediated destruction of bladder tumors (LMD-BT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor recurrence histological identified in biopsy obtained during cystoscopy	Numbers (%) of patients vith histological proven recurrence of bladder tumor after 4 months	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower urinary symptoms caused by laser treatment.	Using the EORTC questionnaire QLQ-BLS24 the extent of symptoms are given on a unique score from 0-100, with 0 being no symptoms and 100 are worst symptoms. Mean and range score in the two arms will be compared statistically.	2 weeks
Side effects to laser treatment.	Symptoms measured by one unique score according to the Clavien-Dindo grading system. Mean and range score in the two arms will be compared statistically.	2 weeks
Pain during laser treatment	The patients record pain on a visual analogue scale of 0-10. Zero corresponds to no pain. Ten correspond to the worst possible pain.	Evaluated immediately after laser treatment

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Investigators: Principal Investigator: Gregers G Hermann, DM Sc, Department of Urology, Frederiksberg hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Treatment; Bladder cancer; Outpatient; Laser; TUR-BT
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: URU06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No