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

Not Applicable

Not yet recruiting

• Conditions: PSMA PET/CT; Prostate Cancer; MpMRI

• Registration Number: NCT06901492
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-23
• Study First Submitted QC: 2025-03-23
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-06-01
• Primary Completion: 2027-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of puncture operation	12 months	Record the time required for each patient's puncture procedure
Patient's pain level	12 months	Based on VAS pain score
Blood loss	12 months	Bleeding volume during and after operation
Complication	12 months	Complications during and after the operation, including urethral injury, hematuria, and urinary tract infection, etc.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China