PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
Recruiting · NCT06923657 · Interventional (participants receive a specific treatment) · Lead sponsor: First Affiliated Hospital of Fujian Medical University
View the official record on ClinicalTrials.gov →Interventions studied
PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsyTRUS guided transperineal saturation biopsy
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.
Who can take part
Age range
30 Years to 85 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- The First Affiliated Hospital of Fujian Medical University - Fuzhou, Fujian, China