RecruitingNot ApplicableNCT06923657

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

Application of PSMA PET/MRI-guided Prostate Targeted Biopsy in Patients With PI-RADS ≤ 3 and Negative Previous Biopsy: A Single-center, Prospective, Open-label, Randomized Controlled Trial


Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

230 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 30 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a specialised imaging scan — a PSMA PET/MRI — can find prostate cancer that was missed on a previous biopsy, especially when standard MRI showed low suspicion for cancer. **You may be eligible if...** - Your PSA (prostate cancer blood test) is above 4 ng/mL - You have had at least one prior biopsy that came back negative for cancer - Your PSA or PHI score has gone up at least twice in a row - Your recent MRI showed a PI-RADS score of 3 or lower (low to moderate suspicion) - Your prostate exam was normal **You may NOT be eligible if...** - You are under 30 or over 85 years old - You have another active cancer - You have previously received cancer treatment or prostate surgery - You cannot have the PET/MRI scan (e.g., contrast allergy, claustrophobia, or metal implants) - You have a blood clotting disorder or active prostate infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy

The experimental group will undergo PSMA PET/MRI examination. For those with positive PSMA PET/MRI results, a PSMA PET/MRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET/MRI results, only TRUS guided transperineal saturation biopsy will be performed. Clinical and pathological data of the patients will be collected for statistical analysis.

DIAGNOSTIC_TESTTRUS guided transperineal saturation biopsy

The control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis.


Locations(1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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NCT06923657


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