Actively Recruiting
Comparison of TB+PB and TB+6SB for Prostate Cancer Diagnosis
Led by Peking University First Hospital · Updated on 2026-03-12
592
Participants Needed
1
Research Sites
56 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 diagnostic efficacy of two novel prostate biopsy schemes, including targeted and perilesional biopsy (TB+PB) and combination of sextant-systematic biopsy and targeted biopsy (TB+6SB). The main questions it aims to answer are: Does TB+PB promote the accurate diagnosis of clinically significant prostate cancer (csPCa)? Could TB+6SB achieve the non-inferior diagnostic efficacy compared to TB+PB scheme? What's the value of TB+6SB in improving the detection of prostate cancer in the negative prostate lobe (contralateral to the index lesion)? In the era of MRI-targeted biopsy (TB), when TB and PB is effectively conducted and allows confident detection of the ROI, do we still need to perform SB? Researchers will compare the cancer detection rates of TB+PB and TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the diagnostic profile of different prostate biopsy schemes through the spatial analysis of the prostate. Participants will: Receive TB+PB or TB+6SB.
CONDITIONS
Official Title
Comparison of TB+PB and TB+6SB for Prostate Cancer Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 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 nodules on digital rectal exam, suspicious lesions on ultrasound or MRI, total PSA over 10 ng/mL, or total PSA 4-10 ng/mL with free-to-total PSA ratio below 0.16 or PSA density over 0.15
- Complete prostate biopsy pathological results with biopsy and MRI done within one month
- Complete clinical information available
You will not qualify if you...
- Unqualified or incomplete prostate MRI data
- Prior radiotherapy, chemotherapy, androgen deprivation therapy, or prostate surgery before MRI or biopsy
- Previous prostate biopsy
- PI-RADS score below 3
- Does not meet prostate biopsy indications
- Unable to cooperate with prostate biopsy
- Refusal to participate by patient or family
- Incomplete clinical information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here