Actively Recruiting
Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer
Led by Peking University First Hospital · Updated on 2024-07-23
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
B
Beijing Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including perilesional/regional systematic biopsy (PB/RSB) and combination of systematic biopsy and targeted biopsy (TB+SB). The main questions it aims to answer are: Does PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB/RSB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB/RSB and combination of TB+SB 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 PB/RSB or TB+SB.
CONDITIONS
Official Title
Evaluation of Perilesional 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 on multiparametric MRI with PI-RADS score greater than 3 and qualified image quality
- Meets prostate biopsy indications including suspicious prostate nodes found by digital rectal exam, suspicious lesions on 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 pathological results
- Time between prostate biopsy and prostate MRI no longer 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 prostate MRI or biopsy
- Previous prostate biopsy
- PI-RADS score less than 4
- Does not meet prostate biopsy indications
- Unable to cooperate with prostate biopsy procedure
- Patient or family refuses to participate
- Incomplete clinical information
AI-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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