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Recruiting NCT06923657

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

No phase Interventional Prostate Cancer Screening PSMA-PET

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy, TRUS guided transperineal saturation biopsy.
Who it may be relevant to
Registry conditions: Prostate Cancer Screening, PSMA-PET. Basic parameters: 30 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Interventions

  • Diagnostic test PSMA 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 test TRUS 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.

Primary outcome measures

  • Diagnostic Sensitivity [Time frame: Perioperative]
  • Diagnostic Specificity [Time frame: Perioperative]
  • Positive Predictive Value(PPV) [Time frame: Perioperative]
  • Negative Predictive Value(NPV) [Time frame: Perioperative]
  • Positive Likelihood Ratio(PLR) [Time frame: Perioperative]
  • Negative Likelihood Ratio(NLR) [Time frame: Perioperative]
  • Correct Diagnostic Index [Time frame: Perioperative]
Secondary outcome measures (4)
  • PRECISION Questionnaire [Time frame: 1 week before biopsy, 1 week after biopsy, 1 month, 3 months, 6 months, 12 months.]
  • EORTC QLQ-C30 Questionnaire [Time frame: Before diagnosis, 1 month, 3 months, 6 months, 12 months]
  • Generalized Anxiety Disorder GAD-7 Scale [Time frame: Before diagnosis, 1 week after diagnosis, 1 month, 3 months, 6 months, 12 months]
  • Decision Conflict Scale, Decision Regret Scale [Time frame: Before diagnosis, 1 month, 3 months, 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • The First Affiliated Hospital of Fujian Medical University — Fuzhou

Identifiers

NCT: NCT06923657 · MRCTA,ECFAH OfFMU[2024]837

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗