Status:
NOT_YET_RECRUITING
FUS-TB VS COG-TB in Small Lesions of Prostate Cancer
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
Huai'an First People's Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
NA
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 an...
Eligibility Criteria
Inclusion
- 1\) male who are between 18 to 80 years old; 2) meet any of the following criteria:
- suspicious nodules of prostate under digital rectal examination(DRE), with any PSA value;
- PSA≥10μg/L;
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06504017
Start Date
August 1 2024
End Date
August 1 2025
Last Update
July 16 2024
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