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

NCT07209865 | Completed Phase 2

• 1 other identifier: FirstAHFujian-68Ga-P16-093
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

PSMA; Prostate cancer; PET imaging; mpMRI

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Within 28 days of imaging, radical prostatectomy will occur.

Secondary Outcomes (1)

• 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

Study Arms (1)

68Ga-P16-093 PET imaging

EXPERIMENTAL

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

Drug: 68Ga-P16-093

Interventions

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.

68Ga-P16-093 PET imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

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

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Weibing Miao, MD

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: June 20, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

CN (1)