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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02604225




Registration number
NCT02604225
Ethics application status
Date submitted
9/11/2015
Date registered
13/11/2015
Date last updated
11/05/2020

Titles & IDs
Public title
Trial of Methoxyflurane With Periprostatic Local Anaesthesia to Reduce the Discomfort of TRUS B
Scientific title
A Phase 3 Double-blind Placebo-controlled Randomized Trial of Methoxyflurane With Periprostatic Local Anaesthesia to Reduce the Discomfort of Transrectal Ultrasound-guided Prostate Biopsy
Secondary ID [1] 0 0
ACTRN12615001105538
Secondary ID [2] 0 0
ANZUP 1501
Universal Trial Number (UTN)
Trial acronym
TRUSB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methoxyflurane
Treatment: Drugs - Placebo

Experimental: Penthrox - Methoxyflurane

Placebo Comparator: Placebo - Saline 0.9%


Treatment: Drugs: Methoxyflurane
Participants randomised to the experimental arm will inhale methoxyflurane administered through the Penthrox® inhaler starting approximately one minute before insertion of the rectal probe.

Treatment: Drugs: Placebo
Participants randomised to the control arm will inhale 0.9% saline administered through the Penthrox® inhaler starting approximately one minute before insertion of the rectal probe.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain rated by participants will be self-rated using a numeric rating scale with verbal anchors from 0 (no trouble at all) to 10 (worst I can imagine).
Timepoint [1] 0 0
Pain will be assessed at 15 minutes after the TRUS biopsy
Secondary outcome [1] 0 0
Other aspects of the biopsy experience rated by participants on the Patient's Experience of TRUS biopsy questionnaire.
Timepoint [1] 0 0
Rated at 15 minutes after the biopsy
Secondary outcome [2] 0 0
Other aspects of the biopsy experience rated by participants on the Patient's Experience of TRUS biopsy questionnaire.
Timepoint [2] 0 0
Rated at 7-35 days after the biopsy
Secondary outcome [3] 0 0
Willingness to undergo a biopsy in the future assessed by a questionnaire designed specifically for this study.
Timepoint [3] 0 0
Rated at 15 minutes and 7-35 days after the biopsy
Secondary outcome [4] 0 0
Urologist's ratings of the participant's biopsy experience, assessed by a questionnaire
Timepoint [4] 0 0
On the same day as the TRUS biopsy
Secondary outcome [5] 0 0
Biopsy completion rate.
Timepoint [5] 0 0
Recorded on day of TRUS biopsy.
Secondary outcome [6] 0 0
Frequency of specified adverse events.
Timepoint [6] 0 0
Adverse events will be recorded after the TRUS biopsy (before the participant leaves the clinic), and 7-35 days after the biopsy.
Secondary outcome [7] 0 0
Frequency of hospitalisation by reviewing hospital records.
Timepoint [7] 0 0
Details will be recorded for each emergency department visit and each non-elective hospital admission that occurs within 30 days of the TRUS biopsy.

Eligibility
Key inclusion criteria
1. Males older than 18 years scheduled to undergo a TRUS biopsy of the prostate.

2. Adequate liver function: ALT, AST, or bilirubin = 2 x ULN

3. Adequate renal function: serum eGFR> 30 ml/min/1.73m2

4. Willing and able to complete questionnaires in English

5. Willing and able to undergo TRUS biopsy within 7 days of randomisation

6. Willing and able to comply with all study requirements, including treatment, timing
and/or nature of required assessments

7. Signed, written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous TRUS biopsy of the prostate

2. Personal or family history of malignant hyperthermia

3. History of significant liver disease

4. Hypersensitivity to fluorinated anaesthetics or other inhalational anaesthetics

5. Concurrent use of barbiturates or tetracycline antibiotics

6. Concurrent illness that may jeopardise the ability of the patient to undergo the
procedures outlined in this protocol with reasonable safety

7. Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule,
including alcohol dependence or drug abuse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2019
Sample size
Target
Accrual to date
Final
420
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Concord Hospital - Concord
Recruitment hospital [2] 0 0
Australian Clinical Trials - Wahroonga
Recruitment hospital [3] 0 0
Casey Hospital - Berwick
Recruitment hospital [4] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2640 - Concord
Recruitment postcode(s) [2] 0 0
2640 - Wahroonga
Recruitment postcode(s) [3] 0 0
- Berwick
Recruitment postcode(s) [4] 0 0
- Prahran
Recruitment postcode(s) [5] 0 0
- Murdoch
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with
periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasound-guided
prostate biopsy (Pain-Free TRUS B).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02604225
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeremy Grummet
Address 0 0
Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02604225