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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179720
• Other study ID #: CSZ02
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: Qilu Hospital of Shandong University
• Contact: Shouzhen Chen, Dr.
• Phone: 18560089085
• Email: chensz[@]mail.sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• puncture stent-assisted transperineal prostate biopsy
Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy

Locations

Country	Name	City	State
China	Qilu hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biopsy complications include (infection, bleeding, etc.)	Biopsy complications include (infection, bleeding, etc.)	1 year
Secondary	Pain score of biopsy patients (NRS score)	Pain score of biopsy patients (NRS score)	1 year
Secondary	Biopsy time	Biopsy time	1 year