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

• Sponsor: Qilu Hospital of Shandong University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05179720
• Collaborator: (none)
• Enrollment: 560
• Arms: 2
• Anticipated Duration (Months): 22.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: puncture stent-assisted transperineal prostate biopsy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 560 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy.Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy.
• Masking: Single (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
• Primary Purpose: Diagnostic
• Official Title: The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. positive rate of biopsy [1 year]

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

Secondary Outcome Measures

1. Biopsy complications include (infection, bleeding, etc.) [1 year]

   Biopsy complications include (infection, bleeding, etc.)

2. Pain score of biopsy patients (NRS score) [1 year]

   Pain score of biopsy patients (NRS score)

3. Biopsy time [1 year]

   Biopsy time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Suspected prostate cancer patients Can tolerate prostate puncture

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qilu Hospital of Shandong University
• ClinicalTrials.gov Identifier: NCT05179720
• Other Study ID Numbers: CSZ02
• First Posted: Jan 5, 2022
• Last Update Posted: Jan 5, 2022
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jan 5, 2022