Prostate Cancer
Conditions
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.
Interventions
PROCEDURECOG-TB: Cognitive Fusion guided prostate targeted Biopsy
Cognitive Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound
PROCEDUREFUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy
MRI-TRUS Fusion guided targeted Biopsy 4 cores under cognitive fusion ultrasound
Sponsors
Huai'an First People's Hospital
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| detection rate of any PCa | 1 week (after pathology） | detection rate of any prostate cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| detection rate(cs PCa and PCa) of TBx | 1 week (after pathology） | detection rate for PI-RADS 4 small lesion (\<5mm) under MRI-TRUS fusion |
Contacts
Primary ContactShangqian Wang, PhD
Backup ContactXu Wang
Outcome results
None listed