Actively Recruiting

Phase Not Applicable
Age: 30Years - 85Years
MALE
NCT06923657

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

Led by First Affiliated Hospital of Fujian Medical University · Updated on 2025-09-15

230

Participants Needed

1

Research Sites

81 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 85Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male participants aged between 30 and 85 years
  • Serum PSA level greater than 4 ng/mL
  • At least one prior negative prostate biopsy
  • At least two consecutive increases in PSA and/or PHI levels
  • Negative digital rectal examination
  • Multiparametric MRI indicating a PI-RADS score of 3 or less
Not Eligible

You will not qualify if you...

  • Age younger than 30 years or older than 85 years
  • Presence of other malignant tumors
  • Previous anti-tumor therapy or prostate surgery (except biopsy)
  • Inability to undergo PSMA PET/MRI (e.g., contrast allergy, claustrophobia)
  • Contraindications to prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection)
  • Severe organ dysfunction such as significant heart, lung, liver, or kidney impairment
  • Incomplete clinical or pathological data

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350005

Actively Recruiting

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Research Team

N

Ning Xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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