The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture
NCT ID: NCT06901492
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-06-01
2028-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Systematic prostate biopsy
The patient will undergo systematic prostate biopsy under TRUS guidance.
Interventions
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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.
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.
Systematic prostate biopsy
The patient will undergo systematic prostate biopsy under TRUS guidance.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
MALE
No
Sponsors
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Nanjing First Hospital, Nanjing Medical University
OTHER
Responsible Party
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Locations
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Nanjing First Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY20250225-08
Identifier Type: -
Identifier Source: org_study_id
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