None listed
Conditions
Brief summary
The aim of this study is to assess the tolerability, safety and cost of transperineal prostate biopsy techniques in men with suspected prostate cancer. Who is this for? You may be eligible to participate in this study if you are scheduled to undergo a transperineal prostate biopsy for suspected prostate cancer, or as part of active surveillance for prostate cancer. Study details Participants who consent to participating in this study will undergo a transperineal prostate biopsy with Penthrox and local anaesthetic by a qualified Urologist at a public hospital. We will assess your pain levels during the biopsy with a visual analogue scale survey and also analyse rates of cancer detection, perioperative complications and costs. We will do this by retrospectively comparing to cohorts of patients who have undergone transperineal biopsies at the same health service prior, under general anaesthetic. Our objective is to demonstrate that transperineal prostate biopsies under local anaesthetic are comfortable for the patients, safe, and just as accurate as those performed under general anaesthetic. Further, we aim to demonstrate that it is more efficient and cost effective, therefore resulting in reduced healthcare costs and improved accessibility with less wait times for patients requiring a prostate biopsy.
Interventions
This project will compare transperineal prostate biopsy under local anaesthetic with Penthrox (intervention arm) versus general anaesthetic (control arm). The biopsy will take approximately 20-30 minutes and will be performed by a urologist.
Intervention arm:
- Local anaesthetic will be lignocaine (200 mg) diluted in saline via subcutaneous route 5 minutes prior to procedure
- Local anaesthetic will be administered by the urologist performing the biopsy
- Penthrox (active ingredient methoxyflu
This project will compare transperineal prostate biopsy under local anaesthetic with Penthrox (intervention arm) versus general anaesthetic (control arm). The biopsy will take approximately 20-30 minutes and will be performed by a urologist. Intervention arm: - Local anaesthetic will be lignocaine (200 mg) diluted in saline via subcutaneous route 5 minutes prior to procedure - Local anaesthetic will be administered by the urologist performing the biopsy - Penthrox (active ingredient methoxyflurane, max dose 6ml) will be delivered via inhalation. Participants will inhale and exhale through the mouthpiece of a Penthrox inhaler attached to a carbon filter. They will be in instructed to inhale and exhale into the mouthpiece for 6-8 breaths, beginning inhalation 30 seconds prior to commencement of the procedure, after which they may inhale intermittently as required for the duration of the biopsy
Sponsors
Austin Health
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults older than 18 years old • Suspected prostate cancer based on Prostate Specific Antigen (PSA) levels, Digital Rectal Examination (DRE) findings, family history and Magnetic Resonance Imaging (MRI) findings • Patients undergoing repeat biopsy for purposes of active surveillance, monitoring or re-staging
Exclusion criteria
• Patients under 18 years old • Inability to give informed consent • Contraindication to administration of local anaesthetic such as allergy • Contraindications to inhaled methoxyflurane including hepatic and renal impairment, hypersensitivity or allergy to methoxyflurane and malignant hyperthermia. • Altered rectal anatomy due to previous surgeries, anorectal malformations that preclude insertion of a transrectal ultrasound probe • Patients with no pre-operative MRI or no index lesions on MRI for target biopsies will be excluded from the sub-analysis of efficacy of prostate cancer detection. However they will be included in the primary end point and other secondary end point analyses • Patients with history of chronic pain
Outcome results
None listed