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Clinical Trial NCT06901492 for PSMA PET/CT, Prostate Cancer, MpMRI is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture 120

Not yet recruiting
Clinical Trial NCT06901492 is an interventional study for PSMA PET/CT, Prostate Cancer, MpMRI and is currently not yet recruiting. Enrollment is planned to begin on 1 June 2025 and continue until the study accrues 120 participants. Led by Nanjing First Hospital, Nanjing Medical University, this study is expected to complete by 1 June 2028. The latest data from ClinicalTrials.gov was last updated on 30 March 2025.
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
Official Title

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

Conditions
PSMA PET/CTProstate CancerMpMRI
Other Study IDs
  • KY20250225-08
NCT ID Number
NCT06901492
Start Date (Actual)
2025-06-01
Last Update Posted
2025-03-30
Completion Date (Estimated)
2028-06-01
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Prostate cancer
PSMA PET/CT
mpMRI
Prostate biopsy
Primary Purpose
Diagnostic
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPET+/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.
ExperimentalPET+/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.
Active ComparatorPET-/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.
Placebo ComparatorPET-/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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Biospy outcome
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 MeasureMeasure DescriptionTime Frame
Duration of puncture operation
Record the time required for each patient's puncture procedure
12 months
Patient's pain level
Based on VAS pain score
12 months
Blood loss
Bleeding volume during and after operation
12 months
Complication
Complications during and after the operation, including urethral injury, hematuria, and urinary tract infection, etc.
12 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
40 Years
Eligible Sexes
Male
  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.

  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.
Nanjing First Hospital, Nanjing Medical University logoNanjing First Hospital, Nanjing Medical University
Study Central Contact
Contact: Hongbin Sun Sun, MD, PHD, +86-02552271061, [email protected]
1 Study Locations in 1 Countries

Jiangsu

Nanjing First Hospital, Nanjing, Jiangsu, 210006, China
Hongbin Sun, MD, PHD, Contact, +86-02552271061, [email protected]