None listed
Conditions
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.
Interventions
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 ins
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.
Sponsors
Monash Health Department of Urology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
• Allergic reaction to local anaesthetic • Patient refusal
Outcome results
None listed