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PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy

RECRUITINGN/ASponsored by First Affiliated Hospital of Fujian Medical University
Actively Recruiting
PhaseN/A
SponsorFirst Affiliated Hospital of Fujian Medical University
Started2025-05-07
Est. completion2026-05-01
Eligibility
Age30 Years – 85 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06923657

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 for csPCa and reducing missed diagnoses.

Eligibility

Age: 30 Years – 85 YearsSex: MALEHealthy volunteers accepted
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

Conditions3

CancerPSMA-PETProstate Cancer Screening

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