Status:
RECRUITING
PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
Lead Sponsor:
First Affiliated Hospital of Fujian Medical University
Conditions:
Prostate Cancer Screening
PSMA-PET
Eligibility:
MALE
30-85 years
Phase:
NA
Brief Summary
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...
Detailed Description
This research intends to prospectively enroll patients with prior negative biopsies, a PI-RADS score ≤ 3, and persistent PSA or PHI elevation, randomly assigning them to the PSMA PET/MRI group (experi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Serum PSA \> 4 ng/mL
- At least one prior negative prostate biopsy
- At least two consecutive increases in PSA and/or PHI
- Negative digital rectal examination
- Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3
- Exclusion Criteria
- Age ≤ 30 years or \> 85 years
- Concurrent presence of other malignant tumors
- Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy)
- Inability to comply with PSMA PET/MRI examination (e.g., contrast allergy, claustrophobia, etc.)
- Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.)
- Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment)
- Incomplete clinical or pathological data
Exclusion
Key Trial Info
Start Date :
May 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT06923657
Start Date
May 7 2025
End Date
December 1 2026
Last Update
September 15 2025
Active Locations (1)
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1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005