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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

puncture stent-assisted transperineal prostate biopsy

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Suspected prostate cancer patients Can tolerate prostate puncture

Exclusion Criteria:

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

Sites / Locations

Qilu hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

puncture stent-assisted transperineal prostate biopsy

transperineal free-hand biopsy

Arm Description

This group of patients underwent puncture stent-assisted transperineal prostate biopsy.

This group of patients underwent perineal free-hand biopsy

Outcomes

Primary Outcome Measures

positive rate of biopsy

Including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer

Secondary Outcome Measures

Biopsy complications include (infection, bleeding, etc.)

Pain score of biopsy patients (NRS score)

Biopsy time

Full Information

NCT ID

NCT05179720

First Posted

December 1, 2021

Last Updated

October 13, 2022

Sponsor

Qilu Hospital of Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT05179720

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy.

Masking

Outcomes Assessor

Masking Description

Randomly assign patient groups according to the random number method.The biopsy sample inspector does not know the patient's biopsy method

Allocation

Randomized

Enrollment

560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

puncture stent-assisted transperineal prostate biopsy

Arm Type

Experimental

Arm Description

This group of patients underwent puncture stent-assisted transperineal prostate biopsy.

Arm Title

transperineal free-hand biopsy

Arm Type

Active Comparator

Arm Description

This group of patients underwent perineal free-hand biopsy

Intervention Type

Other

Intervention Name(s)

puncture stent-assisted transperineal prostate biopsy

Intervention Description

Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy

Primary Outcome Measure Information:

Title

positive rate of biopsy

Description

Including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Biopsy complications include (infection, bleeding, etc.)

Description

Biopsy complications include (infection, bleeding, etc.)

Time Frame

1 year

Title

Pain score of biopsy patients (NRS score)

Description

Pain score of biopsy patients (NRS score)

Time Frame

1 year

Title

Biopsy time

Description

Biopsy time

Time Frame

1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shouzhen Chen, Dr.

Phone

18560089085

chensz@mail.sdu.edu.cn

Facility Information:

Facility Name

Qilu hospital

City

Jinan

State/Province

Shandong

ZIP/Postal Code

276600

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

shouzhen chen

Phone

18560089085

Jiangxin98@mail.sdu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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