Status:
UNKNOWN
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
Lead Sponsor:
The University of Hong Kong
Conditions:
Prostate Cancer
Prostatic Hyperplasia
Eligibility:
MALE
40-80 years
Phase:
NA
Brief 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 sam...
Detailed Description
The incidence of prostate cancer (PCa) has increased considerably in recent years \[1, 2\]. The reported lifetime risk for men in Hong Kong to be diagnosed with PCa is 1 in 31 before the age of 75, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04108871
Start Date
October 3 2018
End Date
September 1 2021
Last Update
September 30 2019
Active Locations (1)
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1
Division of Urology, Department of Surgery, Queen Mary Hospital
Hong Kong, Hong Kong