Actively Recruiting
PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2025-09-15
230
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for csPCa and reducing missed diagnoses.
CONDITIONS
Official Title
PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged between 30 and 85 years
- Serum PSA level greater than 4 ng/mL
- At least one prior negative prostate biopsy
- At least two consecutive increases in PSA and/or PHI levels
- Negative digital rectal examination
- Multiparametric MRI indicating a PI-RADS score of 3 or less
You will not qualify if you...
- Age younger than 30 years or older than 85 years
- Presence of other malignant tumors
- Previous anti-tumor therapy or prostate surgery (except biopsy)
- Inability to undergo PSMA PET/MRI (e.g., contrast allergy, claustrophobia)
- Contraindications to prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection)
- Severe organ dysfunction such as significant heart, lung, liver, or kidney impairment
- Incomplete clinical or pathological data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
N
Ning Xu
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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