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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05179720

Enrollment

560

Registered

2022-01-05

Start date

2022-01-01

Completion date

2023-12-31

Last updated

2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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

Interventions

OTHERpuncture stent-assisted transperineal prostate biopsy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

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

Intervention model description

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

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Contacts

Primary ContactShouzhen Chen, Dr.

chensz@mail.sdu.edu.cn18560089085

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026