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

October 13, 2022 updated by: Qilu Hospital of Shandong University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

560

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 276600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Suspected prostate cancer patients Can tolerate prostate puncture

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSZ02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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