NCT02604225

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_3 cancer

Timeline
Completed

Started Dec 2015

Typical duration for phase_3 cancer

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

4 years

First QC Date

November 9, 2015

Last Update Submit

May 7, 2020

Conditions

Cancer

Keywords

Anaethesiology

Outcome Measures

Primary Outcomes (1)

  • 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).

    Pain will be assessed at 15 minutes after the TRUS biopsy

Secondary Outcomes (7)

  • Other aspects of the biopsy experience rated by participants on the Patient's Experience of TRUS biopsy questionnaire.

    Rated at 15 minutes after the biopsy

  • Other aspects of the biopsy experience rated by participants on the Patient's Experience of TRUS biopsy questionnaire.

    Rated at 7-35 days after the biopsy

  • Willingness to undergo a biopsy in the future assessed by a questionnaire designed specifically for this study.

    Rated at 15 minutes and 7-35 days after the biopsy

  • Urologist's ratings of the participant's biopsy experience, assessed by a questionnaire

    On the same day as the TRUS biopsy

  • Biopsy completion rate.

    Recorded on day of TRUS biopsy.

  • +2 more secondary outcomes

Study Arms (2)

Penthrox

EXPERIMENTAL

Methoxyflurane

Drug: Methoxyflurane

Placebo

PLACEBO COMPARATOR

Saline 0.9%

Drug: Placebo

Interventions

MethoxyfluraneDRUG

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

Also known as: Penthrox®
Penthrox
PlaceboDRUG

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.

Also known as: Saline 0.9%
Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males older than 18 years scheduled to undergo a TRUS biopsy of the prostate.
  • Adequate liver function: ALT, AST, or bilirubin ≤ 2 x ULN
  • Adequate renal function: serum eGFR\> 30 ml/min/1.73m2
  • Willing and able to complete questionnaires in English
  • Willing and able to undergo TRUS biopsy within 7 days of randomisation
  • Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
  • Signed, written informed consent

You may not qualify if:

  • Previous TRUS biopsy of the prostate
  • Personal or family history of malignant hyperthermia
  • History of significant liver disease
  • Hypersensitivity to fluorinated anaesthetics or other inhalational anaesthetics
  • Concurrent use of barbiturates or tetracycline antibiotics
  • Concurrent illness that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Concord Hospital

Concord, New South Wales, 2640, Australia

Location

Australian Clinical Trials

Wahroonga, New South Wales, 2640, Australia

Location

Casey Hospital

Berwick, Victoria, Australia

Location

The Alfred Hospital

Prahran, Victoria, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Location

Westmead Hospital

Westmead, Australia

Location

Canterbury Urology Research Trust

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Neoplasms

Interventions

MethoxyfluraneSodium Chloride

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jeremy Grummet

    Principal Investigator

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 13, 2015

Study Start

December 1, 2015

Primary Completion

December 5, 2019

Study Completion

December 30, 2019

Last Updated

May 11, 2020

Record last verified: 2020-05

Locations

AU(6)NZ(1)