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
NCT04108871 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2019-09-30
Summary
Tranperineal prostate biopsy(TPB) and Transrectal prostate biopsy(TRUSB) are now both routine diagnosis methods of prostate cancer in Queen Mary Hospital. The TRUSB has been the most common way to sample prostate tissue for decades. The TPB has been employed as one of our routine diagnosis methods in early 2018. The aim of this study is to evaluate whether Tranperineal prostate biopsy using a noval transperineal access system under local anaesthesia is non-inferior to standard 12-cores Transrectal prostate biopsy in detecting prostate cancer (PCa), in patients with clinical suspicion of PCa with no prior prostate biopsy.
Conditions
- Prostate Cancer
- Prostatic Hyperplasia
Interventions
- PROCEDURE
-
Prostate Biopsy
Samples of tissue are removed from the prostate for histopathological diagnosis of prostate cancer through the use of a needle with the assistance of transrectal ultrasound.
Sponsors & Collaborators
-
The University of Hong Kong
lead OTHER
Principal Investigators
-
Wayne Lam · The University of Hong Kong
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-03
- Primary Completion
- 2021-06-01
- Completion
- 2021-09-01
Countries
- Hong Kong
Study Locations
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