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NCT Number: NCT06901492

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

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

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Key information

Conditions

PSMA PET/CT Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases MpMRI Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prostate biopsy guided by PSMA PET/CT

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

The patient will undergo systematic prostate biopsy under TRUS guidance.

Primary outcomes

  1. Biospy outcome

    Time frame: 12 months

    Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between puncture methods and set up a diagnostic model.

Secondary outcomes

  1. Duration of puncture operation

    Time frame: 12 months

    Record the time required for each patient's puncture procedure

  2. Patient's pain level

    Time frame: 12 months

    Based on VAS pain score

  3. Blood loss

    Time frame: 12 months

    Bleeding volume during and after operation

  4. Complication

    Time frame: 12 months

    Complications during and after the operation, including urethral injury, hematuria, and urinary tract infection, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongbin Sun Sun, MD, PHD

CONTACT

[email protected]

+86-02552271061

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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