The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture

NCT06901492 · tracked via the Priya Life Science China tracker

Sponsor

Nanjing First Hospital, Nanjing Medical University

Phase

Not applicable

Started

2025-06-01

Last updated

2025-03-30

Condition(s) studied

PSMA PET/CTProstate CancerMpMRI

Investigational drug(s) / intervention(s)

Prostate biopsy guided by PSMA PET/CTProstate biopsy guided by mpMRI/USSystematic prostate biopsy

Prostate biopsy guided by PSMA PET/CT: The patient will undergo pelvic non-contrast CT imaging. After co-registration of the CT images with 68Ga-PSMA PET/CT data at corresponding anatomical levels, a percutaneous gluteal approach will be utilized for CT-guided prostate biopsy.

Prostate biopsy guided by mpMRI/US: The patient will undergo transrectal ultrasound (TRUS) prostate scanning. After co-registration and precise image fusion of TRUS findings with multiparametric MRI (mpMRI) data, a transperineal percutaneous approach will be employed to perform TRUS-guided prostate biopsy.

Systematic prostate biopsy: The patient will undergo systematic prostate biopsy under TRUS guidance.

Study summary

The present study is designed to explore the value of targeted puncture guided by PSMA PET/CT or mpMRI in the diagnosis of patients with low PSA and initial negative prostate biopsy

Eligibility

Sex

MALE

Min age

40 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥40 years, male; 2. Serum PSA level 4-20 ng/mL; 3. Serum PSA level 4-20 ng/mL; 4. No contraindications to PSMA-PET/CT or MRI; 5. Signed informed consent. Exclusion Criteria: 1. Serum PSA \>20 ng/mL; 2. History of prostate surgery/radiotherapy; 3. Acute prostatitis; 4. Coagulation disorders or active infection; 5. Severe internal/external hemorrhoids, perianal, rectal, or gluteal lesions; 6. Allergy to local anesthetics; 7. Inability to tolerate the biopsy procedure.

Primary outcome measure(s)

Biospy outcome — 12 months
Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model.

Trial sites (1)

Facility	City	Region	Status
Nanjing First Hospital	Nanjing	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06901492 on ClinicalTrials.gov ↗ ← All trials in China