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68Ga-P16-093 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients

A Pilot Prospective Comparison of 68Ga-P16-093 and 68Ga-PSMA-617 in the Same Group of Prostate Cancer Patients

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04796467
Enrollment
50
Registered
2021-03-12
Start date
2020-10-01
Completion date
2022-10-01
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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 widely studied 68Ga-PSMA-617. This pilot study was prospectively designed to evaluate the early dynamic distribution of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-617 in the same group of 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-617, PSMA-11 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 targeting PSMA, 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. Mark A. Green et.al had demonstrated that 68Ga-P16-093 provided diagnostic information that appeared equivalent to 68Ga-PSMA-11 in prostate cancer patients presenting with biochemical recurrence, and 68Ga-P16-093 exhibits less urinary excretion than observed for 68Ga-PSMA-11. This pilot study was prospectively designed to evaluate the early dynamic distribution of 68Ga-P16-093 compared with 68Ga-PSMA-617 in the same group of prostate cancer patients.

Interventions

Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT.

Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-P16-093. Tracer doses of 68Ga-P16-093 will be used to image lesions of prostate cancer by PET/CT.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* confirmed treated or untreated prostate cancer patients; * 68Ga-PSMA617 and 68Ga-P16-093 PET/CT within two consecutive days; * 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.

Design outcomes

Primary

MeasureTime frameDescription
Metabolic parametersthrough study completion, an average of 1 year]the early dynamic distribution (SUVmax in tumor lesions and SUVmean in normal organs at different time points) of 68Ga-P16-093 in comparison with 68Ga-PSMA-617 in the same group of prostate cancer patients.

Secondary

MeasureTime frameDescription
detection capability of tumorthrough study completion, an average of 1 yearthe tumor number detected by 68Ga-P16-093 PET/CT for prostate cancer in comparison with 68Ga-PSMA-617 PET/CT
SUVmax of tumorthrough study completion, an average of 1 yearthe tumor uptake on 68Ga-P16-093 PET/CT for prostate cancer in comparison with 68Ga-PSMA-617 PET/CT

Other

MeasureTime frameDescription
PSMA expression and SUVthrough study completion, an average of 1 yearCorrelation between PSMA expression and SUV in PET

Countries

China

Contacts

Primary ContactZhaohui Zhu, MD
13611093752@163.com86-13611093752
Backup ContactGuochang Wang, MD
guochang1007@163.com86-18516822732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026