FUS-TB VS COG-TB in Small Lesions of Prostate Cancer

N/ANot Yet RecruitingNCT06504017

The First Affiliated Hospital with Nanjing Medical University200 enrolled

Overview

To compare the positive detection rates of COG-TB vs FUS-TB for prostate cancer with PI-RADS 4 small lesions.

Prostate cancer (PCA) is the most frequent malignancy in male urogenital system. According to the World Health Organization's 2020 GLOBOCAN statistics, there are approximately 1.4 million new cases and 375,000 deaths worldwide. PCa is the second most common tumor in male patients after lung cancer and ranks fifth among cancer causes of death. Currently, prostate specific antigen ( PSA ), digital rectal examination (DRE), multi-parametric magnetic resonance imaging (mpMRI), prostate specific membrane antigen positron emission Tomography/computed tomography (PSMA PET/CT) and other detection methods have played an important role in the diagnosis of PCa, but the gold standard for confirming PCa is the histopathological examination of prostate biopsy. Performing mpMRI before biopsy can help detect and locate prostate cancer with ISUP grade ≥2. Studies have shown that the prostate imaging reporting and data system (PI-RADS) may help improve the detection of clinically significant cancers. Biopsy should be considered when PI-RADS score 4 or 5. This clinical study intends to use the mpMRI-TRUS image fusion ultrasound system to assist in guiding FUS-TB, comparing to COG-TB to evaluate the application value of mpMR-TRUS image fusion in the detection of PCa in prostate biopsy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Prostate Cancer

Interventions

COG-TB: Cognitive Fusion guided prostate targeted BiopsyPROCEDURE

Cognitive Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound

FUS-TB: MRI-TRUS Fusion guided prostate targeted BiopsyPROCEDURE

MRI-TRUS Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\) male who are between 18 to 80 years old; 2) meet any of the following criteria: 1. suspicious nodules of prostate under digital rectal examination(DRE), with any PSA value; 2. PSA≥10μg/L; 3. 4μg/L≤PSA\<10μg/L,f/t PSA≤0.16; 3) suspicious lesions under mpMRI, at least one lesion \<5mm, PI-RADS 4; 4) good compliance; 5) must sign the informed consent form. Exclusion Criteria: * 1\) diagnosed prostate cancer or acute prostatitis; 2) acute infection, or clinically significant urinary tract infection; 3) performed prostate puncture within 1 month; 4) cardiac insufficiency; 5) having high risk of bleeding or taking anticoagulants for a long time; 6) severe internal or external hemorrhoids, perianal or rectal lesions; 7) having severe osteoarticular diseases that can not be performed lithotomy; 8) hypertensive crisis; 9) patients who should not be anesthetized; 10) patients with mental illness or mental disorders and unable to understand the informed consent; 11) patients with electronic devices such as built-in artificial pacemaker, cochlear implants or nerve stimulators; 12) other surgical contraindications, or those considered unsuitable by the investigators.

Outcomes

Primary Outcomes

detection rate of any PCa

detection rate of any prostate cancer

Time frame: 1 week (after pathology）

Secondary Outcomes

detection rate(cs PCa and PCa) of TBx

detection rate for PI-RADS 4 small lesion (\<5mm) under MRI-TRUS fusion

Time frame: 1 week (after pathology）

Central Contacts

Shangqian Wang, PhD

CONTACT

0086-025-68306360 wsq5501@126.com

Xu Wang

CONTACT

0086-025-68306360 jsphkj@163.com

Data from ClinicalTrials.gov

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