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68Ga-P16-093 PET Imaging in Newly Diagnosed Prostate Cancer
NCT07209865Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2024
- Primary completion
- Dec 2025
- Countries
- 1
- Sponsor
- The First Hospital of Fujian Medical University
- Modality
- Small Molecules
- Drugs
- 68Ga-P16-093
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, open-label, single-arm trial of 68Ga-P16-093 in prostate cancer (PCa), sponsored by The First Hospital of Fujian Medical University. Primary endpoints: Sensitivity of 68Ga-P16-093 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology at 28 days and Specificity of 68Ga-P16-093 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology at 28 days. Started Oct 2024; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
68Ga-P16-093 PET imaging
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.
03
Who it enrols
Male patients with newly diagnosed, biopsy-confirmed, treatment-naive prostate adenocarcinoma scheduled for radical prostatectomy within 28 days, without other malignancies.
04
Endpoints
Primary
Sensitivity of 68Ga-P16-093 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology
Specificity of 68Ga-P16-093 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology
Secondary
Comparison of Detection Rates for Intraprostatic Tumors Between 68Ga-P16-093 PET Imaging and mpMRI
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