CancerPhase 3TRUSBNCT02604225
Trial of Methoxyflurane With Periprostatic Local Anaesthesia to Reduce the Discomfort of TRUS B
A Phase 3 study testing Methoxyflurane in people with Cancer, run by University of Sydney at 7 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer
- What is being tested?
- Methoxyflurane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2015to 30 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Australia6 sites
Casey Hospital
Berwick, Victoria
Concord Hospital
Concord, New South Wales, 2640
Fiona Stanley Hospital
Murdoch, Western Australia
The Alfred Hospital
Prahran, Victoria
Australian Clinical Trials
Wahroonga, New South Wales, 2640
Westmead Hospital
Westmead
About this study
Official 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
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).
Read the detailed description
Background Transrectal ultrasound-guided (TRUS) prostate biopsy is associated with significant discomfort, despite the use of periprostatic infiltration of local anaesthetic (PILA).
General aim To determine the efficacy and safety of inhaled methoxyflurane plus PILA versus PILA alone in men undergoing TRUS biopsy of the prostate.
Objectives (endpoints)
To determine the effects of inhaled methoxyflurane on:
Primary
- Pain-rated by participants 15 minutes after biopsy. Secondary
- Other aspects of the biopsy experience rated by participants 15 minutes and 7-35 days after the biopsy
- Willingness to undergo a biopsy in the future
- Urologist's ratings of the participant's biopsy experience (study specific questionnaire completed after the biopsy)
- Biopsy completion (80% or more of the planned number of biopsies being taken)
- Frequency of specified adverse events (CTC AE v4.03 and Clavien-Dindo Classification).
- Frequency of hospitalisation
Design Multi-centre, placebo-controlled, double-blinded, centrally randomised (1:1), stratified, phase 3 trial.
Target population Men scheduled to undergo their first TRUS biopsy of the prostate for a raised PSA or abnormal digital rectal examination (DRE).
Study treatments
Participants randomised to inhaled:
Methoxyflurane (Penthrox®, experimental group). OR Placebo (0.9% saline, control group
All participants are subsequently treated with PILA (2% lignocaine), injected into and around the prostate about 5 minutes before the biopsy.
Assessments Participants will be assessed at time of scheduling of the TRUS prostate biopsy (up to 84 days prior to randomisation), on the day of biopsy, and at the post biopsy clinic (7-35 days after the biopsy). Assessments comprise of medical history and standard blood tests at baseline, patient questionnaire on the day of biopsy and post(7-35 days) biopsy and safety assessments on the day of biopsy and post (7--35 days) biopsy.
Statistical considerations 420 participants provides over 85% power at the two-sided 5% level of significance to detect a 0.80 point difference in mean pain scores (on scale from 0-10) assuming a standard deviation of 2.5 whilst allowing for missing data. A 0.80 point shift in mean pain scores should correspond to a reduction of more than 1/3 in the proportion of men reporting troublesome levels of pain.
- Conditions
- Cancer
- Being tested
- Methoxyflurane, Placebo
- Keywords
- Anaethesiology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDrug
Also called Penthrox®
Participants randomised to the experimental arm will inhale methoxyflurane administered through the Penthrox® inhaler starting approximately one minute before insertion of the rectal probe.
PlaceboDrug
Also called Saline 0.9%
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.
| Study group | Role | What they receive |
|---|---|---|
| Penthrox | Experimental | Methoxyflurane Receives: Drug: Methoxyflurane |
| Placebo | Placebo comparator | Saline 0.9% Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Rated at 15 minutes and 7-35 days after the biopsy
Urologist's ratings of the participant's biopsy experience, assessed by a questionnaire
Measured: On the same day as the TRUS biopsy
Biopsy completion rate.
Measured: Recorded on day of TRUS biopsy.
Frequency of specified adverse events.
Measured: Adverse events will be recorded after the TRUS biopsy (before the participant leaves the clinic), and 7-35 days after the biopsy.
Frequency of hospitalisation by reviewing hospital records.
Measured: Details will be recorded for each emergency department visit and each non-elective hospital admission that occurs within 30 days of the TRUS biopsy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startDec 2015
- Primary completion5 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Australian and New Zealand Urogenital and Prostate Cancer Trials Group
- Responsible party
- Sponsor
- Investigators
- Jeremy Grummet, Study chair, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604225
- Sponsor's protocol ID
- ANZUP 1501
- Other IDs
- ACTRN12615001105538
- Acronym
- TRUSB
- Status last verified
- May 2020
- First submitted
- 9 Nov 2015
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02604225
- Acronym / sponsor ID
- TRUSB / ANZUP 1501
- Conditions
- Cancer
- Keywords
- Anaethesiology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Australian and New Zealand Urogenital and Prostate Cancer Trials Group
- Study start
- Dec 2015
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Background Transrectal ultrasound-guided (TRUS) prostate biopsy is associated with significant discomfort, despite the use of periprostatic infiltration of local anaesthetic (PILA).
General aim To determine the efficacy and safety of inhaled methoxyflurane plus PILA versus PILA alone in men undergoing TRUS biopsy of the prostate.
Objectives (endpoints)
To determine the effects of inhaled methoxyflurane on:
Primary
- Pain-rated by participants 15 minutes after biopsy. Secondary
- Other aspects of the biopsy experience rated by participants 15 minutes and 7-35 days after the biopsy
- Willingness to undergo a biopsy in the future
- Urologist's ratings of the participant's biopsy experience (study specific questionnaire completed after the biopsy)
- Biopsy completion (80% or more of the planned number of biopsies being taken)
- Frequency of specified adverse events (CTC AE v4.03 and Clavien-Dindo Classification).
- Frequency of hospitalisation
Design Multi-centre, placebo-controlled, double-blinded, centrally randomised (1:1), stratified, phase 3 trial.
Target population Men scheduled to undergo their first TRUS biopsy of the prostate for a raised PSA or abnormal digital rectal examination (DRE).
Study treatments
Participants randomised to inhaled:
Methoxyflurane (Penthrox®, experimental group). OR Placebo (0.9% saline, control group
All participants are subsequently treated with PILA (2% lignocaine), injected into and around the prostate about 5 minutes before the biopsy.
Assessments Participants will be assessed at time of scheduling of the TRUS prostate biopsy (up to 84 days prior to randomisation), on the day of biopsy, and at the post biopsy clinic (7-35 days after the biopsy). Assessments comprise of medical history and standard blood tests at baseline, patient questionnaire on the day of biopsy and post(7-35 days) biopsy and safety assessments on the day of biopsy and post (7--35 days) biopsy.
Statistical considerations 420 participants provides over 85% power at the two-sided 5% level of significance to detect a 0.80 point difference in mean pain scores (on scale from 0-10) assuming a standard deviation of 2.5 whilst allowing for missing data. A 0.80 point shift in mean pain scores should correspond to a reduction of more than 1/3 in the proportion of men reporting troublesome levels of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Penthrox | Experimental | Drug: MethoxyfluraneMethoxyflurane |
| Placebo | Placebo comparator | Drug: PlaceboSaline 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethoxyfluraneAlso: Penthrox®Participants randomised to the experimental arm will inhale methoxyflurane administered through the Penthrox® inhaler starting approximately one minute before insertion of the rectal probe. | Drug | Penthrox |
| PlaceboAlso: Saline 0.9%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. | Drug | Placebo |
Primary outcome
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).
Time frame: Pain will be assessed at 15 minutes after the TRUS biopsy
7 secondary outcomes
Other aspects of the biopsy experience rated by participants on the Patient's Experience of TRUS biopsy questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: Rated at 15 minutes and 7-35 days after the biopsy
Urologist's ratings of the participant's biopsy experience, assessed by a questionnaire
Time frame: On the same day as the TRUS biopsy
Biopsy completion rate.
Time frame: Recorded on day of TRUS biopsy.
Frequency of specified adverse events.
Time frame: Adverse events will be recorded after the TRUS biopsy (before the participant leaves the clinic), and 7-35 days after the biopsy.
Frequency of hospitalisation by reviewing hospital records.
Time frame: Details will be recorded for each emergency department visit and each non-elective hospital admission that occurs within 30 days of the TRUS biopsy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Grummet study chair
Principal Investigator
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methoxyflurane in people with Cancer, run by University of Sydney at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Pain will be assessed at 15 minutes after the TRUS biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.