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Trial registered on ANZCTR


Registration number
ACTRN12620001145998p
Ethics application status
Not yet submitted
Date submitted
7/05/2020
Date registered
2/11/2020
Date last updated
2/11/2020
Date data sharing statement initially provided
2/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Transperineal prostate biopsy under local anaesthetic compared to general anaesthetic for men with suspected prostate cancer
Scientific title
Local Anesthetic Transperineal Prostate Biopsy (LATProBE) Trial - A trial to assess the tolerability and efficacy of transperineal prostate biopsy under local anaesthetic compared to general anaesthetic for men with suspected prostate cancer
Secondary ID [1] 301226 0
None
Universal Trial Number (UTN)
U1111-1251-7275
Trial acronym
LATProBE
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 317388 0
Condition category
Condition code
Cancer 315493 315493 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single diagnostic freehand transperineal prostate biopsy performed either under local anaesethetic (intervention) or template grid biopsy under general anaesthetic (control) by a qualified urologist. This will take place in a public hospital.

1) Freehand transperineal prostate biopsy is a procedure performed whilst the patient is awake. Local anaesthetic (1% lignocaine, 10-15ml injected into perineal skin and peri-prostatic) is used to anaesthetise the perineum and prostate, and a probe is inserted into the rectum to take core biopsies of the prostate gland. Effectiveness of anaesthetic is tested by the clinician gentle placing a sharp instrument (i.e. tissue forceps) onto the perineal skin and asking the patient if they feel pain. If the anaesthetic is effective - the biopsy is completed. 'Freehand' means the surgeon is in control of the probe and directs the core biopsy device accordingly to the area of interest

2) Template grid biopsy is performed under general anaesthesia (as per anaesthetist discretion) so the patient is asleep for the whole procedure. Similarly a probe is inserted into the rectum to visualise the prostate but the biopsies are taken as per a per-determined guide (i.e. a grid) which allows a set template of biopsies to be taken from the prostate.
Intervention code [1] 317530 0
Diagnosis / Prognosis
Comparator / control treatment
Control group - current standard practice transperineal prostate template biopsy under general anaesthetic. This technique differs in 2 ways:
1) Patients are under general anaesthesia rather than awake and have local anaesethetic
2) A grid is used and a template (pre-determined pattern) of biopsies are taken rather than freehand which is controlled and up to the clinician performing the biopsy
Control group
Active

Outcomes
Primary outcome [1] 323733 0
Overall prostate cancer detection rate and clinically significant prostate cancer detection (Gleason Grading greater than or equal to 7 or IUSP grade group greater than or equal to 2).
Timepoint [1] 323733 0
2 weeks post prostate biopsy
Primary outcome [2] 324099 0
Health economic cost :
1) Difference in resource use and costs from hospital medical records
2) cost-utility analysis (CUA)
- $ per DALY averted or QALY gained
- QALY measured by Eq-5D-5L questionnaire
Timepoint [2] 324099 0
30 days post biopsy
Secondary outcome [1] 382745 0
Patient experience during procedure using visual analogue scale


Timepoint [1] 382745 0
Pain score for local anaesthetic participants - before, during and after procedure.
For general anaesthetic participants only before and after the procedure
Secondary outcome [2] 382746 0
Patient satisfaction post-procedure- survey using validated patient satisfaction questionnaire CSQ-8.
Timepoint [2] 382746 0
1, 7 and 14 days post biopsy
Secondary outcome [3] 383219 0
30-day complications according to Clavien-Dindo classification
Timepoint [3] 383219 0
Phonecall at 30 days
Secondary outcome [4] 383220 0
quality of life assessed using the Eq-5D-5L Quality of Life Questionnaire
Timepoint [4] 383220 0
7, 14 and 28 days

Eligibility
Key inclusion criteria

• Male patients
• Clinical suspicion of prostate cancer – elevated PSA, abnormal DRE or suspicious lesion on MRI
• Previous diagnosis of PCa patients on active surveillance still included
• At least medically fit for trans-perineal prostate biopsy at least under general anaesthesia
• Adequate mobility to sit in lithotomy position
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Allergic reaction to local anaesthetic
• Patient refusal

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


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Initially we intend to conduct a pilot study with 20 patients in each arm to assess feasibility. If successful then we will proceed to multi-site trial recruitment.
To adequately power this study we based our calculation based on published literature compared cancer detection rates of transperineal biopsy (TPBx) versus transrectal ultrasound (TRUS) biopsy Our power calculation is 310 patients per group, 620 patients in total are required for the study to be powered to 80% with a non-inferior limit of 10% for cancer detection between the groups. For statistical analysis, the chi-square test for cancer detection between the groups and Mann-Whitney U test will be used to compare pain scores.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
620
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 16632 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [2] 16633 0
Western Hospital - Footscray - Footscray
Recruitment hospital [3] 17578 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 17579 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [5] 17580 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 17581 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 30227 0
3165 - East Bentleigh
Recruitment postcode(s) [2] 30228 0
3011 - Footscray
Recruitment postcode(s) [3] 31321 0
4029 - Herston
Recruitment postcode(s) [4] 31322 0
4020 - Redcliffe
Recruitment postcode(s) [5] 31323 0
3128 - Box Hill
Recruitment postcode(s) [6] 31324 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 305676 0
Hospital
Name [1] 305676 0
Monash Health Department of Urology
Country [1] 305676 0
Australia
Primary sponsor type
Hospital
Name
Monash Health Department of Urology
Address
Monash Health Department of Urology
Moorabbin Hospital
823-865 Centre Rd
Bentleigh East
VIC 3165
Country
Australia
Secondary sponsor category [1] 306085 0
Hospital
Name [1] 306085 0
Western Health Department of Urology
Address [1] 306085 0
Western Health Department of Urology
160 Gordon Street
Footscray VIC 3011
Country [1] 306085 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305957 0
Research Support Services Monash Health
Ethics committee address [1] 305957 0
Research Support Services Monash Health
Level 2, I Block
Monash Medical Centre 246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 305957 0
Australia
Date submitted for ethics approval [1] 305957 0
01/11/2020
Approval date [1] 305957 0
Ethics approval number [1] 305957 0

Summary
Brief summary
The aim of this study to assess the safety and efficacy of two transperineal prostate biopsy methods
Who is it for?
You may be eligible to join this study if you are male and have a clinical suspicion of prostate cancer (PCa) and are scheduled to undergo a prostate biopsy. Patients with a previous diagnosis of PCa on active surveillance are included.
Study details
Participants in this study will be allocated to one of two biopsy groups. Participants will undergo single diagnostic freehand transperineal prostate biopsy performed either under local anaesethetic (intervention) or template grid biopsy under general anaesthetic (control) by a qualified urologist. This will take place in a public hospital.
We will assess proportion of patients with prostate cancer positive biopsies, pain score during biopsy procedure and patient satisfaction as well as any complications.
The aim of this study is to show that local anaesthetic transperineal prostate biopsy is a safe and just as accurate as prostate biopsy under general anaesethesia. Another aim is to show it is more efficient in terms of health economics therefore can be adopted by more public hospitals and ultimately widen the access to prostate biopsy for patients.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes
n/a

Contacts
Principal investigator
Name 102206 0
Dr David Wetherell
Address 102206 0
Monash Health
Department of Urology
Moorabbin Hospital
823-865 Centre Rd
Bentleigh East
VIC 3165
Country 102206 0
Australia
Phone 102206 0
+61 423966526
Fax 102206 0
Email 102206 0
[email protected]
Contact person for public queries
Name 102207 0
David Wetherell
Address 102207 0
Monash Health
Department of Urology
Moorabbin Hospital
823-865 Centre Rd
Bentleigh East
VIC 3165
Country 102207 0
Australia
Phone 102207 0
+61 423966526
Fax 102207 0
Email 102207 0
[email protected]
Contact person for scientific queries
Name 102208 0
David Wetherell
Address 102208 0
Monash Health
Department of Urology
Moorabbin Hospital
823-865 Centre Rd
Bentleigh East
VIC 3165
Country 102208 0
Australia
Phone 102208 0
+61 423966526
Fax 102208 0
Email 102208 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.