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

NCT05179720 | Unknown

• 1 other identifier: CSZ02
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• positive rate of biopsy

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

  1 year

Secondary Outcomes (3)

• Biopsy complications include (infection, bleeding, etc.)

  1 year

• Pain score of biopsy patients (NRS score)

  1 year

• Biopsy time

  1 year

Study Arms (2)

puncture stent-assisted transperineal prostate biopsy

EXPERIMENTAL

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

Other: puncture stent-assisted transperineal prostate biopsy

transperineal free-hand biopsy

ACTIVE COMPARATOR

This group of patients underwent perineal free-hand biopsy

Other: puncture stent-assisted transperineal prostate biopsy

Interventions

puncture stent-assisted transperineal prostate biopsy OTHER

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

puncture stent-assisted transperineal prostate biopsy; transperineal free-hand biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected prostate cancer patients Can tolerate prostate puncture

You may not qualify if:

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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital

Jinan, Shandong, 276600, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Shouzhen Chen, Dr.

CONTACT

18560089085; chensz@mail.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomly assign patient groups according to the random number method.The biopsy sample inspector does not know the patient's biopsy method
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 5, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-01

Locations

CN (1)