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68Ga-P16-093 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI

68Ga-P16-093 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI

Recruiting
18-80 years
Male
Phase 1/2

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Overview

68Ga-P16-093 is a novel radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-P16-093 PET imaging (PET/CT or PET/MRI) in patients with newly diagnosed, treatment-naive prostate cancer, and performed a head-to-head comparison with multi-parameter magnetic resonance imaging (mpMRI).

Description

68Ga-P16-093 is a novel radiotracer targeting PSMA. Previously, we conducted multiple studies confirming the clinical application of 68Ga-P16-093 PET/CT. However, multi-parametric magnetic resonance imaging (mpMRI) still holds a dominant position in the imaging diagnosis of prostate cancer. In this study, we will further evaluate the diagnostic performance of 68Ga-P16-093 positron emission tomography (PET/CT or PET/MRI) in newly diagnosed and untreated prostate cancer patients, with a head-to-head comparison to mpMRI.

Eligibility

Inclusion Criteria:

  • Biopsy-confirmed adenocarcinoma of the prostate.
  • No anti-tumor treatment received prior to the PET imaging.
  • Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
  • Radical prostatectomy scheduled within 28 days after PET imaging.

Exclusion Criteria:

  • Patients with other malignant tumors
  • Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.

Study details
    Prostate Cancer (Adenocarcinoma)

NCT07209865

First Affiliated Hospital of Fujian Medical University

15 October 2025

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