Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men
Prostate Cancer, Prostatic Hyperplasia
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Biopsy, Transperineal Prostate Biopsy, Prostate Cancer Detection, Transrectal Prostate Biopsy
Eligibility Criteria
Inclusion Criteria:
- Serum PSA larger or equal to 20ng/mL
- Suspected tumour clinical stage T2 on DRE
- No previous history of prostate biopsy
- Medically fit to undergo procedures according to study protocol
Exclusion Criteria:
- Patients who are unable to provide written informed consent
- Known history of prostate cancer
- Contraindication to prostate biopsy
- Had pre-biopsy mpMRI
- Rectal abnormality precluding transrectal ultrasound
Sites / Locations
- Division of Urology, Department of Surgery, Queen Mary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Transperineal Prostate Biopsy
Transrectal Prostate Biopsy
The biopsy needed is inserted to the prostate through the perineal skin, with the assistance of an access system device known as PrecisionPoint. It utilises a single access needle cannula mounted directly on to the ultrasound probe, which acts as an access point traversing through the perineal skin. 4 - 5 cores are obtained from the anterior, mid and posterior zone of each side of the prostate.
The biopsy needle penetrates through the bowel (rectum) to the prostate to obtain 12 cores of prostate tissues from the lateral and medial base, midzone and apex of each side of the prostate (1 core each).