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

March 23, 2025 updated by: Nanjing First Hospital, Nanjing Medical University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hongbin Sun Sun, MD, PHD
  • Phone Number: +86-02552271061
  • Email: docshb@126.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
        • Contact:
          • Hongbin Sun, MD, PHD
          • Phone Number: +86-02552271061
          • Email: docshb@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET+/mpMRI+ group
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on both PSMA PET and mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT.
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.
Experimental: PET+/mpMRI- group
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on PSMA PET and negative on mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT.
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.
Active Comparator: PET-/mpMRI+ group
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on PSMA PET and positive on mpMRI. These patients will undergo prostate biopsy guided by mpMRI and US.
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.
Placebo Comparator: PET-/mpMRI- group
Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show negative findings on both PSMA PET and mpMRI. These patients will undergo systematic prostate biopsy.
Diagnostic test: Systematic prostate biopsy
The patient will undergo systematic prostate biopsy under TRUS guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biospy outcome
Time Frame: 12 months
Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 23, 2025

First Submitted That Met QC Criteria

March 23, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20250225-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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