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Clinical Trials/NCT05179720
NCT05179720
Unknown
N/A

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

Qilu Hospital of Shandong University1 site in 1 country560 target enrollmentJanuary 1, 2022
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Qilu Hospital of Shandong University
Enrollment
560
Locations
1
Primary Endpoint
positive rate of biopsy
Last Updated
3 years ago

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

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Suspected prostate cancer patients Can tolerate prostate puncture

Exclusion Criteria

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

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)

Study Sites (1)

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