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

Nanjing Medical University

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Procedure: FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy; Procedure: COG-TB: Cognitive Fusion guided prostate targeted Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06504017

2024-SR-359

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

COG-TB: Cognitive Fusion guided prostate targeted Biopsy

Other group

Description:

Targeted Biopsy 4 cores under cognitive fusion ultrasound

Treatment:

Procedure: COG-TB: Cognitive Fusion guided prostate targeted Biopsy

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

Experimental group

Description:

Targeted Biopsy 4 cores under MRI-TRUS Fusion ultrasound

Treatment:

Procedure: FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy