|
Trial 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
|
|
Trial Acronym:
|
Pain-Free TRUS B
|
|
Protocol Number:
|
ANZUP 1501
|
|
Trial Design:
|
Multi-centre, placebo-controlled, double-blinded, centrally randomised (1:1), stratified, phase 3 trial
|
|
Collaborators:
|
|
|
ANZ Study Chairs:
|
Nicholas Buchan
|
|
ANZ Coordinating Centre:
|
NHMRC CTC
|
|
Trial Coordinator:
|
Kate Ford
|
|
Trial Email:
|
trusb@ctc.usyd.edu.au
|
Recruitment Aim: |
420 participants
|
|
Patient Population:
|
Men scheduled to undergo their first TRUS biopsy of the prostate for a raised PSA or abnormal digital rectal examination (DRE)
|
|
Intervention:
|
Methoxyflurane (Penthrox®)
|
|
Primary Outcome:
|
Pain-rated by participants 15 minutes after biopsy
|
|
Secondary Outcomes:
|
To determine effects on:
1. Other aspects of the biopsy experience rated by participants 15 minutes and 7-35 days after the biopsy
2. Willingness to undergo a biopsy in the future
3. Urologist’s ratings of the participant’s biopsy experience (study specific questionnaire completed after the biopsy)
4. Biopsy completion (80% or more of the planned number of biopsies being taken)
5. Frequency of specified adverse events (CTC AE v4.03 and Clavien-Dindo Classification).
7.Frequency of hospitalisation
|
|
Status:
|
Closed to recruitment |
|
Sites Recruiting:
|
NSW
VIC
- The Alfred Hospital
- Casey Hospital
WA
New Zealand
- Canterbury Urology Research Trust
- Cardinal Points Research
- Tauranga Urology Research
|
|
Further Information:
|
Click here
|