68Ga-P16-093 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Primary Prostate Cancer Patients

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: 68Ga-P16-093; Drug: 68Ga-PSMA-11

• Registration Number: NCT05324332
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Prostate-specific membrane antigen (PSMA)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the most widely studied 68Ga-PSMA-11. This pilot study was evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-11 in the same group of primary prostate cancer patients.

Detailed Description

Prostate cancer (PC) is one of the most common malignancies worldwide in men, with persistently high numbers dying from this disease. Due to low levels of glycolysis in prostate cancer cell, the uses of 18F-FDG PET/CT to detect prostate cancer and its metastases are limited. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga-labeling have been developed. 68Ga-PSMA PET/CT has demonstrated desirable sensitivity and specificity in the detection of prostate cancer lesions, which can find many micro lesions that cannot be identified by CT, MRI and bone scan. 68Ga-P16-093, a novel radiopharmaceutical modified based on 68Ga-PSMA-11, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga(III). The HBED-based chelating ligand binds the 68Ga3+ ion with high affinity in a pseudo-octahedral N2O4 coordination sphere by its two phenolate O, two amino-acetate carboxylate O, and two amino N donor atoms. This pilot study was prospectively designed to evaluate the diagnostic performance of 68Ga-P16-093 compared with 68Ga-PSMA-11 in the same group of primary prostate cancer patients.

Study Timeline

• Study First Submitted: 2022-04-03
• Study First Submitted QC: 2022-04-09
• Study First Posted: 2022-04-12
• Study Start: 2022-04-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-11-24
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-31

Recruitment & Eligibility

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

Inclusion Criteria

• histologically confirmed untreated primary prostate cancer patients;
• 68Ga-PSMA-11 and 68Ga-P16-093 PET/CT within a week;
• signed written consent.

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Exclusion Criteria

• known allergy against PSMA;
• any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-P16-093 and 68Ga-PSMA-11 PET/ CT scan	68Ga-PSMA-11	Patients of Prostate cancer PET/CT imaging: In two consecutive days, each patient underwent whole-body PET/CT scan after intravenous administration of 68Ga-P16-093 and 68Ga-PSMA-11, respectively.
68Ga-P16-093 and 68Ga-PSMA-11 PET/ CT scan	68Ga-P16-093	Patients of Prostate cancer PET/CT imaging: In two consecutive days, each patient underwent whole-body PET/CT scan after intravenous administration of 68Ga-P16-093 and 68Ga-PSMA-11, respectively.

Primary Outcome Measures

Name	Time	Method
Tumor detection rate	through study completion, an average of 1 year	comparing the number of tumor detected by 68Ga-P16-093 and 68Ga-PSMA-11 PET/CT

Secondary Outcome Measures

Name	Time	Method
standardized uptake value (SUV) of tumor	through study completion, an average of 1 year	comparing the SUVmax of tumor derived from 68Ga-P16-093 and 68Ga-PSMA-11 PET/CT

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China