The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy

Study Overview
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Brief Summary
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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
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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

Official Title
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The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: puncture stent-assisted transperineal prostate biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected prostate cancer patients Can tolerate prostate puncture Exclusion Criteria: Symptomatic acute or chronic inflammation of the prostate Patients with other cancers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: puncture stent-assisted transperineal prostate biopsy<br>This group of patients underwent puncture stent-assisted transperineal prostate biopsy. | Other: puncture stent-assisted transperineal prostate biopsy<br>* Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy<br>|
| Active Comparator: transperineal free-hand biopsy<br>This group of patients underwent perineal free-hand biopsy | Other: puncture stent-assisted transperineal prostate biopsy<br>* Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive rate of biopsy | Including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy complications include (infection, bleeding, etc.) | Biopsy complications include (infection, bleeding, etc.) | 1 year | 
| Pain score of biopsy patients (NRS score) | Pain score of biopsy patients (NRS score) | 1 year | 
| Biopsy time | Biopsy time | 1 year |