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NCT06901492 | NOT YET RECRUITING | PSMA PET/CT

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

Condition or disease

PSMA PET/CT

Prostate Cancer

MpMRI

Intervention/treatment

Prostate biopsy guided by PSMA PET/CT

Prostate biopsy guided by mpMRI/US

Systematic prostate biopsy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : The Diagnostic Application of PSMA PET/MR in Patients with PSA <20 Ng/ml and Initial Negative Prostate Biopsy
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2027-06-01
Estimated Study Completion Date : 2028-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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.
The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture

Location Details

NCT06901492

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How to Participate

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Locations

Not yet recruiting

China, Jiangsu

Nanjing First Hospital

Nanjing, Jiangsu, China, 210006