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Completed

NCT Number: NCT07209865

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

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).

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Key information

Conditions

Prostate Cancer (Adenocarcinoma) Adenocarcinoma Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

68Ga-P16-093

Drug

Intravenous injection of Ga-P16-093 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT plus PET/MRI acquisition according to standard methods.

Primary outcomes

  1. Sensitivity of 68Ga-P16-093 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants

    Time frame: Within 28 days of imaging, radical prostatectomy will occur.

    Using histopathology from radical prostatectomy as the reference standard, validate the true positive detection rate of PET for prostate lesions. Two experienced nuclear medicine physicians, blinded to all other imaging and clinical history of the patients, independently assessed the PET images. Any disagreements were resolved by consensus.

  2. Specificity of 68Ga-P16-093 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants

    Time frame: Within 28 days of imaging, radical prostatectomy will occur.

    Using histopathology from radical prostatectomy as the reference standard, validate the true negative detection rate of PET for prostate lesions. Two experienced nuclear medicine physicians, blinded to all other imaging and clinical history of the patients, independently assessed the PET images. Any disagreements were resolved by consensus.

Secondary outcomes

  1. Comparison of Detection Rates for Intraprostatic Tumors Between 68Ga-P16-093 PET Imaging and mpMRI

    Time frame: Within 1-2 hours of 68Ga-P16-093 dosing, a whole body PET scan will be taken

    The number of intraprostatic lesions detected on imaging will be determined by each of independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 68Ga-P16-093 PET scan results as well as the mpMRI results.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

68Ga-P16-093 PET Imaging in the Diagnostic Study of Newly Diagnosed, Untreated Prostate Cancer, With a Head-to-head Comparison to mpMRI

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Jul 6, 2026

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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