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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: COG-TB: Cognitive Fusion guided prostate targeted Biopsy; Procedure: FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shangqian Wang, PhD; Phone Number: 0086-025-68306360; Email: wsq5501@126.com
• Study Contact Backup: Name: Xu Wang; Phone Number: 0086-025-68306360; Email: jsphkj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: COG-TB: Cognitive Fusion guided prostate targeted Biopsy; Targeted Biopsy 4 cores under cognitive fusion ultrasound	Procedure: COG-TB: Cognitive Fusion guided prostate targeted Biopsy; Cognitive Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound
Experimental: FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy; Targeted Biopsy 4 cores under MRI-TRUS Fusion ultrasound	Procedure: FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy; MRI-TRUS Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
detection rate of any PCa	detection rate of any prostate cancer	1 week (after pathology）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
detection rate(cs PCa and PCa) of TBx	detection rate for PI-RADS 4 small lesion (<5mm) under MRI-TRUS fusion	1 week (after pathology）

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Huai'an First People's Hospital
• Investigators: Principal Investigator: Shangqian Wang, PhD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2024-SR-359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No