NCT06504017

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

FUS-TB VS COG-TB in Prostate Cancer With PI-RADS 4 Small Lesions - a Predictive, Multi-center, Exploring Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	COG-TB: Cognitive Fusion guided prostate targeted Biopsy	Cognitive Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound
PROCEDURE	FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy	MRI-TRUS Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-05-01
• Completion: 2025-08-01
• First posted: 2024-07-16
• Last updated: 2024-07-16