The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 560
- Locations
- 1
- Primary Endpoint
- positive rate of biopsy
Study Overview
Brief Summary
This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy
Detailed Description
This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy 560 patients were enrolled. The main result is the positive rate of biopsy: including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer.Secondary results include: (1)Biopsy complications include (infection, bleeding, etc.).(2)Pain score of biopsy patients (NRS score).(3) Biopsy time
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Masking Description
Randomly assign patient groups according to the random number method.The biopsy sample inspector does not know the patient's biopsy method
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Suspected prostate cancer patients Can tolerate prostate puncture
Exclusion Criteria
- •Symptomatic acute or chronic inflammation of the prostate Patients with other cancers
Arms & Interventions
puncture stent-assisted transperineal prostate biopsy
This group of patients underwent puncture stent-assisted transperineal prostate biopsy.
Intervention: puncture stent-assisted transperineal prostate biopsy (Other)
transperineal free-hand biopsy
This group of patients underwent perineal free-hand biopsy
Intervention: puncture stent-assisted transperineal prostate biopsy (Other)
Outcomes
Primary Outcomes
positive rate of biopsy
Time Frame: 1 year
Including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer
Secondary Outcomes
- Biopsy time(1 year)
- Biopsy complications include (infection, bleeding, etc.)(1 year)
- Pain score of biopsy patients (NRS score)(1 year)