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

November 1, 2022 updated by: Peking Union Medical College Hospital

A Pilot Comparison of 68Ga-P16-093 and 68Ga-PSMA-11 in the Same Group of Primary Prostate Cancer Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-P16-093 and 68Ga-PSMA-11 PET/ CT scan
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.
Drug: 68Ga-P16-093
Intravenous injection of 68Ga-P16-093 with the dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of prostate cancer by PET/CT.
Other Names:
  • 68Ga-P16-093 injection
Drug: 68Ga-PSMA-11
Intravenous injection of 68Ga-PSMA-11 with the dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg. Tracer doses of 68Ga-PSMA-11 will be used to image lesions of prostate cancer by PET/CT.
Other Names:
  • 68Ga-PSMA-11 injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSMA expression and SUV
Time Frame: through study completion, an average of 1 year
Correlation between PSMA immunoreactive score and SUVmax of tumor
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 3, 2022

First Submitted That Met QC Criteria

April 9, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUMCH P16-093

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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