Actively Recruiting
Personalized Optimization of Systematic Prostate Biopsy
Led by Fujian Medical University Union Hospital · Updated on 2025-12-18
330
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 the basis of establishing a model with DRS stratification to reduce the cores of systematic biopsy, we propose the (12 cores -x) model innovatively. We hope that through this prospective study to verify the efficacy of the model and provide patients with a new biopsy model with high accuracy and fewer complications. In this study， patients with suspected prostate cancer were randomly divided into two groups. Experimental group received targeted biopsy combined personalized systematic biopsy, and the control group received systematic biopsy .The differences of the detection rate of Prostate cancer between the two groups were compared.
CONDITIONS
Official Title
Personalized Optimization of Systematic Prostate Biopsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with lesions found on rectal examination with any PSA value
- Patients with abnormal lesions found on imaging with any PSA value
- PSA greater than 10.0 ng/ml
- Patients with PSA between 4.0 and 10.0 ng/ml and free PSA/total PSA ratio less than 0.16
- MRI performed prior to biopsy with PI-RADS V2.1 score 3 or higher
- Willing to truthfully complete study surveys
- Willing to undergo follow-up
- Signed informed consent by patient or authorized family member
You will not qualify if you...
- Previous prostate biopsy
- History of prostate-related surgery, radiotherapy, or anti-androgen therapy
- Severe hemorrhoids or rectal stenosis making transrectal ultrasound intolerable
- Clotting disorders
- Severe systemic diseases such as cardiovascular or cerebrovascular disorders
- Unable to follow the study plan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Urology, Fujian Union Hospital, Fujian Medical University
Fuzhou, Fujian, China, 350000
Actively Recruiting
Research Team
J
Jiabing Zheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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