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

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Other: puncture stent-assisted transperineal prostate biopsy

• Registration Number: NCT05179720
• Lead Sponsor: Qilu Hospital of Shandong University

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 Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-16
• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Posted: 2022-01-05
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-18
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 560

Inclusion Criteria

Suspected prostate cancer patients Can tolerate prostate puncture

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Exclusion Criteria

Symptomatic acute or chronic inflammation of the prostate Patients with other cancers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
puncture stent-assisted transperineal prostate biopsy	puncture stent-assisted transperineal prostate biopsy	This group of patients underwent puncture stent-assisted transperineal prostate biopsy.
transperineal free-hand biopsy	puncture stent-assisted transperineal prostate biopsy	This group of patients underwent perineal free-hand biopsy

Primary Outcome Measures

Name	Time	Method
positive rate of biopsy	1 year	Including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer

Secondary Outcome Measures

Name	Time	Method
Biopsy time	1 year	Biopsy time
Biopsy complications include (infection, bleeding, etc.)	1 year	Biopsy complications include (infection, bleeding, etc.)
Pain score of biopsy patients (NRS score)	1 year	Pain score of biopsy patients (NRS score)

Trial Locations

Locations (1)

Qilu hospital; 🇨🇳 Jinan, Shandong, China