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

Not Applicable

Recruiting

• Conditions: Prostate Cancer (Adenocarcinoma)
• Interventions: Drug: 68Ga-P16-093

• Registration Number: NCT07209865
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-P16-093 PET/CT	68Ga-P16-093	Intravenous injection of 68Ga-P16-093 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT or PET/MRI acquisition according to standard methods.

Primary Outcome Measures

Name	Time	Method
Sensitivity of 68Ga-P16-093 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants	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.
Specificity of 68Ga-P16-093 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China