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Trial registered on ANZCTR


Registration number
ACTRN12624001119583
Ethics application status
Approved
Date submitted
3/09/2024
Date registered
17/09/2024
Date last updated
17/09/2024
Date data sharing statement initially provided
17/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Transperineal prostate biopsy under local anaesthetic: an analysis of cost, efficacy and patient tolerability in Australia
Scientific title
Transperineal prostate biopsy under local anaesthetic in adults with suspected or confirmed prostate cancer: an analysis of cost, efficacy and patient tolerability in Australia
Secondary ID [1] 312880 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer
 335030 0
Condition category
Condition code
Surgery 331537 331537 0 0
Surgical techniques
Cancer 331538 331538 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 329418 0
Treatment: Drugs
Comparator / control treatment
The general anaesthetic is administered by the anaesthetist. Induction commences approximately 5 minutes prior, and emergence from anaesthesia approximately 5 minutes post completion of the biopsy procedure.
The comparator arm will comprise retrospective cohorts of patients who have undergone transperineal biopsies at the same health service prior, under general anaesthetic between August 2022 and August 2024, prior to prospective recruitment of the intervention arm of this study.
Control group
Historical

Outcomes
Primary outcome [1] 339282 0
Healthcare costs
Timepoint [1] 339282 0
Cost data will be collected for all participants at completion of the study
Secondary outcome [1] 439360 0
Pain
Timepoint [1] 439360 0
For intervention arm participants, this will be assessed two days post procedure. There is no control arm for this secondary endpoint as it is a retrospective cohort of patients who underwent procedure under general anaesthetic.
Secondary outcome [2] 439361 0
Efficacy of cancer detection
Timepoint [2] 439361 0
Once reports are available post surgery
Secondary outcome [3] 439362 0
Perioperative complications such as urinary retention, infection and haematuria
Timepoint [3] 439362 0
Rate of complications up to 4 weeks post surgery as reported by patients- this will be assessed via review of medical records

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2024
Actual
Date of last participant enrolment
Anticipated
18/09/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317319 0
Government body
Name [1] 317319 0
Austin Health
Country [1] 317319 0
Australia
Primary sponsor type
Government body
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 319602 0
Government body
Name [1] 319602 0
Grampians Health
Address [1] 319602 0
Country [1] 319602 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316051 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316051 0
https://www.austin.org.au/Office-for-Research/
Ethics committee country [1] 316051 0
Australia
Date submitted for ethics approval [1] 316051 0
01/02/2024
Approval date [1] 316051 0
25/06/2024
Ethics approval number [1] 316051 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136618 0
A/Prof Joseph Ischia
Address 136618 0
Austin Health. 145 Studley Road, Heidelberg 3084 VIC
Country 136618 0
Australia
Phone 136618 0
+61438004100
Fax 136618 0
Email 136618 0
[email protected]
Contact person for public queries
Name 136619 0
Jennifer Xu
Address 136619 0
Austin Health. 145 Studley Road Heidelberg 3084 VIC
Country 136619 0
Australia
Phone 136619 0
+61394965000
Fax 136619 0
Email 136619 0
[email protected]
Contact person for scientific queries
Name 136620 0
Jennifer Xu
Address 136620 0
Austin Health. 145 Studley Road Heidelberg 3084 VIC
Country 136620 0
Australia
Phone 136620 0
+61394965000
Fax 136620 0
Email 136620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.