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

Nanjing Medical University

Status: Not yet enrolling

Conditions: PSMA PET/CT; MpMRI; Prostate Cancer

Treatments: Diagnostic Test: Prostate biopsy guided by PSMA PET/CT; Diagnostic Test: Prostate biopsy guided by mpMRI/US; Diagnostic Test: Systematic prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06901492

KY20250225-08

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups, including a placebo group

PET+/mpMRI+ group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Prostate biopsy guided by PSMA PET/CT

PET+/mpMRI- group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Prostate biopsy guided by PSMA PET/CT

PET-/mpMRI+ group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Prostate biopsy guided by mpMRI/US

PET-/mpMRI- group

Placebo Comparator group

Description:

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.

Treatment:

Diagnostic Test: Systematic prostate biopsy