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

NCT ID: NCT05324332

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2025-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

68Ga-P16-093

Intervention Type: DRUG

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.

68Ga-PSMA-11

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

68Ga-P16-093 injection; 68Ga-PSMA-11 injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaohui Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaohui Zhu, MD

Role: CONTACT

13611093752@163.com

86-13611093752

Guochang Wang, MD

Role: CONTACT

guochang1007@163.com

86-18516822732

Facility Contacts

Zhaohui Zhu, MD

Role: primary

13611093752@163.com

86-13611093752

Guochang Wang, MD

Role: backup

guochang1007@163.com

86-18516822732

References

Wang G, Li L, Zhu M, Zang J, Wang J, Wang R, Yan W, Zhu L, Kung HF, Zhu Z. A prospective head-to-head comparison of [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11 PET/CT in patients with primary prostate cancer. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):3126-3136. doi: 10.1007/s00259-023-06283-4. Epub 2023 May 26.

Reference Type: DERIVED

PMID: 37233785 (View on PubMed)

Other Identifiers

PekingUMCH P16-093

Identifier Type: -

Identifier Source: org_study_id