Pain-Free TRUS B Trial

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


ANZ Study Chairs:

Nicholas Buchan

ANZ Coordinating Centre:


Trial Coordinator:

Kate Ford

Trial Email:

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)


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


Closed to recruitment

Sites Recruiting:

  • Westmead Hospital
  • The Alfred Hospital
  • Casey Hospital
  • Fiona Stanley Hospital
New Zealand
  • Canterbury Urology Research Trust
  • Cardinal Points Research
  • Tauranga Urology Research

Further Information:

lick here

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