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

Shandong University

Status: Unknown

Conditions: Prostate Cancer

Treatments: Other: puncture stent-assisted transperineal prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05179720

CSZ02

Details and patient eligibility

About

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

Full 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

Enrollment: 560 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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560 participants in 2 patient groups

puncture stent-assisted transperineal prostate biopsy

Experimental group

Description:

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

Treatment:

Other: puncture stent-assisted transperineal prostate biopsy

transperineal free-hand biopsy

Active Comparator group

Description:

This group of patients underwent perineal free-hand biopsy

Treatment:

Other: puncture stent-assisted transperineal prostate biopsy