Actively Recruiting
Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer
Led by Peking University First Hospital · Updated on 2025-06-13
300
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including targeted biopsy plus sextant biopsy (3TB+6SB) and combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB). The main questions it aims to answer are: Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of 3TB+6SB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of 3TB+6SB and combination of 3TB+12SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life. Participants will: Receive 3TB+6SB or 3TB+12SB.
CONDITIONS
Official Title
Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45 and 85 years
- No previous prostate biopsy
- Single suspicious lesion with complete multiparametric MRI data and PI-RADS score of 3 or higher
- Meets prostate biopsy indications such as suspicious prostate nodes by digital rectal exam, suspicious lesions by ultrasound or MRI, total PSA >10 ng/mL, or total PSA 4-10 ng/mL with free-to-total PSA ratio <0.16 or PSA density >0.15
- Complete prostate biopsy pathology results
- Time between prostate biopsy and MRI no more than one month
- Complete clinical information available
You will not qualify if you...
- Unqualified or incomplete multiparametric MRI data
- Prior radiotherapy, chemotherapy, androgen deprivation therapy, or surgery before MRI or biopsy
- Previous prostate biopsy
- PI-RADS score less than 3
- Does not meet indication for prostate biopsy
- Unable to cooperate to complete the prostate biopsy
- Patient or family refuses to participate
- Incomplete clinical information
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
Y
Yi Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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