NCT06901492

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

The Diagnostic Application of PSMA PET/MR in Patients with PSA <20 Ng/ml and Initial Negative Prostate Biopsy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Conditions

• PSMA PET/CT
• Prostate Cancer
• MpMRI

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Systematic prostate biopsy	The patient will undergo systematic prostate biopsy under TRUS guidance.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2025-03-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: China