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
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
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
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.)
Biopsy complications include (infection, bleeding, etc.)
Pain score of biopsy patients (NRS score)
Pain score of biopsy patients (NRS score)
Biopsy time
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
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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
No
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
Email
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
Email
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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