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Trial Title:
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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
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Trial Acronym:
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Pain-Free TRUS B
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Protocol Number:
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ANZUP 1501
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Trial Design:
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Multi-centre, placebo-controlled, double-blinded, centrally randomised (1:1), stratified, phase 3 trial
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Collaborators:
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ANZ Study Chairs:
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Nicholas Buchan
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ANZ Coordinating Centre:
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NHMRC CTC
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Trial Coordinator:
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Claudia Bishop
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Trial Email:
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trusb@ctc.usyd.edu.au
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Recruitment Aim: |
420 participants
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Patient Population:
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Men scheduled to undergo their first TRUS biopsy of the prostate for a raised PSA or abnormal digital rectal examination (DRE)
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Intervention:
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Methoxyflurane (Penthrox®)
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Primary Outcome:
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Pain-rated by participants 15 minutes after biopsy
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Secondary Outcomes:
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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
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Status:
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Active and Recruiting
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Sites Recruiting:
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NSW
VIC
- The Alfred Hospital
- Casey Hospital
WA
New Zealand
- Canterbury Urology Research Trust
- Cardinal Points Research
- Tauranga Urology Research
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Further Information:
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Click here
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