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

Phase 2CompletedNCT07209865

First Affiliated Hospital of Fujian Medical University82 enrolled

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer (Adenocarcinoma)

Interventions

68Ga-P16-093DRUG

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

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

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.

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

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

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.

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

Secondary Outcomes

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

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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.