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

RecruitingNAAges 30 Years - 85 YearsMaleFirst Affiliated Hospital of Fujian Medical Unive…
NCT06923657 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy
  • TRUS guided transperineal saturation biopsy
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Where

1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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