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Not yet recruiting NCT06901492

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

No phase Interventional PSMA PET/CT Prostate Cancer MpMRI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prostate biopsy guided by PSMA PET/CT, Prostate biopsy guided by mpMRI/US, Systematic prostate biopsy.
Who it may be relevant to
Registry conditions: PSMA PET/CT, Prostate Cancer, MpMRI. Basic parameters: from 40 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • 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.
  • 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.
  • Diagnostic test Systematic prostate biopsy
    The patient will undergo systematic prostate biopsy under TRUS guidance.

Primary outcome measures

  • Biospy outcome [Time frame: 12 months]
Secondary outcome measures (4)
  • Duration of puncture operation [Time frame: 12 months]
  • Patient's pain level [Time frame: 12 months]
  • Blood loss [Time frame: 12 months]
  • Complication [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Age ≥40 years, male;
  • Serum PSA level 4-20 ng/mL;
  • Serum PSA level 4-20 ng/mL;
  • No contraindications to PSMA-PET/CT or MRI;
  • Signed informed consent.

Exclusion criteria

  • Serum PSA >20 ng/mL;
  • History of prostate surgery/radiotherapy;
  • Acute prostatitis;
  • Coagulation disorders or active infection;
  • Severe internal/external hemorrhoids, perianal, rectal, or gluteal lesions;
  • Allergy to local anesthetics;
  • Inability to tolerate the biopsy procedure.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Nanjing First Hospital — Nanjing

Identifiers

NCT: NCT06901492 · KY20250225-08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗