Clinical trial NCT06504017: FUS-TB VS COG-TB in Small Lesions of Prostate Cancer
Official title: FUS-TB VS COG-TB in Prostate Cancer With PI-RADS 4 Small Lesions - a Predictive, Multi-center, Exploring Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Huai'an First People's Hospital
First posted: 2024-07-16
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: detection rate of any PCa
timeFrame: 1 week (after pathology）
Secondary outcomes:
measure: detection rate(cs PCa and PCa) of TBx
timeFrame: 1 week (after pathology）
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shangqian Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: