Status:
RECRUITING
Personalized Optimization of Systematic Prostate Biopsy
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
50-95 years
Phase:
NA
Brief Summary
Targeted biopsy combined systematic biopsy is the gold standard for diagnosis of prostate cancer. Excessive cores in systematic biopsy increases the risk of puncture trauma， bleeding and infection. On...
Detailed Description
In this study, patients with suspected prostate cancer were were enrolled at our institution, a public referral tertiary center. After written consent was obtained，Patients were randomly assigned to t...
Eligibility Criteria
Inclusion
- Patients with lesions found on rectal examination with any PSA value;
- Patients with abnormal lesions found on imaging with any PSA value;
- PSA \>10.0 ng.ml-1;
- Patients with PSA of 4.0-10.0 ng.ml-1 and fPSA/tPSA \< 0.16; (5 ) mpMRI was performed prior to biopsy and Prostate Imaging Reporting and Data System (PI-RADS V2.1) assessment category ≥3
- (6) Willing to truthfully fill in the subject survey scale; (7) Willing to undergo follow-up; (8) The patient himself or his authorized immediate family member has signed the informed consent for clinical trial.
Exclusion
- previous biopsy cases;
- Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy;
- Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound
- clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention.
- unable to follow the plan.
Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT05998278
Start Date
August 23 2023
End Date
December 30 2025
Last Update
December 18 2025
Active Locations (1)
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1
Department of Urology, Fujian Union Hospital, Fujian Medical University
Fuzhou, Fujian, China, 350000