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

Recruiting now · Not applicable

Conditions studied: Prostate Cancer Screening, PSMA-PET

In brief

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.

Key facts

Study ID

NCT06923657

Run by

First Affiliated Hospital of Fujian Medical University

People needed

230

Starts

2025-05-07

Expected to finish

2026-12-01

Last updated by the study team

2026-05-28

Who can join

Age: 30 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)

Full record on ClinicalTrials.gov

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