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NCT06923657 | NOT YET RECRUITING | Prostate Cancer Screening

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

First Affiliated Hospital of Fujian Medical University

Information provided by (Responsible Party):

n ing X U

Brief 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.

Condition or disease

Prostate Cancer Screening

PSMA-PET

Intervention/treatment

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

TRUS guided transperineal saturation biopsy

Phase

NA

Detailed Description:

This research intends to prospectively enroll patients with prior negative biopsies, a PI-RADS score ≤ 3, and persistent PSA or PHI elevation, randomly assigning them to the PSMA PET/MRI group (experimental group) and the TRUS-guided transperineal saturation biopsy group (control group). The research aims to evaluate the application of PSMA PET/MRI in clinically suspected prostate cancer patients with prior negative biopsies, comparing the differences in csPCa detection rates between PSMA PET/MRI-TRUS guided prostate targeted biopsy and TRUS-guided saturation biopsy.

Study Type : INTERVENTIONAL
Estimated Enrollment : 230 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : 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
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2026-05-01
Estimated Study Completion Date : 2026-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 85 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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
    • PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy

    Location Details

    NCT06923657

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    China, Fujian

    The First Affiliated Hospital of Fujian Medical University

    F U-axis, Fujian, China, 350005