PSMA Specific [68Ga]-P137 Peptide Probe for PET Imaging in Prostate Cancer

NCT ID: NCT04560725

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2024-12-01

Brief Summary

To study the radioactive uptake of [68Ga]P137 in the lesion sites of PCa patients and evaluate the ability of [68Ga]P137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).

Detailed Description

Prostate cancer is the most common malignancy of the male reproductive system.Prostate specific membrane antigen is a highly specific prostatic epithelial cell membrane antigen, which is highly expressed in solid tumors such as prostate cancer. More than 90% of prostate cancer cells express PSMA, so PSMA can be used as an important imaging target for prostate cancer.Positron emission tomography has the advantages of non-invasive, high resolution and high sensitivity, etc. The PET tracer based on PSMA radiographic label is developing rapidly, which is of great significance for the early diagnosis, prognosis and treatment of prostate cancer.Used for radionuclide 68Ga has a half-life of PET imaging (T1/2 = 68 min) is appropriate, prepared from 68Ge-68Ga generator, relatively low cost, coordination marking method is simple, easy to realize automatic synthesis technology and advantages of medicine preparation, so 68Ga- labeled PSMA targeted molecular probe in prostate cancer has been widely applied in the diagnosis of disease.

[68Ga]P137 is a novel PSMA targeted molecular probe labeled with 68Ga. DOTA is used as a bifunctional linker to coordinate with 68Ga3+. The labeling method is simple, the biological stability is high, the tumor site has obvious radioactive enrichment, and the imaging effect is superior.This project provides research on [68Ga]P137 PET/CT imaging for patients with suspected PCa, and provides basis for early diagnosis of PCa, formulation of treatment plan and efficacy evaluation.

Conditions

Prostate Cancer

Study Design

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

Study Groups

[68Ga] P137

Imaging cohort. All study participants will be allocated to this arm (single-arm study).Study participants will undergo \[68Ga\]P137 PET/CT scans.

Group Type: EXPERIMENTAL

11C-Choline

Intervention Type: DRUG

11C-choline (0.05-0.1mCi/kg) was injected intravenously one week before or after the \[68Ga\]P137 PET/CT examination, and imaging of the head and body cadres was performed 20 min after the injection using Philips Gemini TF16 or Siemens Biograph M-CT flow PET/CT

Interventions

11C-Choline

11C-choline (0.05-0.1mCi/kg) was injected intravenously one week before or after the \[68Ga\]P137 PET/CT examination, and imaging of the head and body cadres was performed 20 min after the injection using Philips Gemini TF16 or Siemens Biograph M-CT flow PET/CT

Intervention Type: DRUG

Other Intervention Names

11C-CH

Eligibility Criteria

Inclusion Criteria

• Men over 18 years of age need to undergo [68Ga]P137 PET/CT examination for suspected prostate cancer.
• The patients can fully understand and voluntarily participate in this experiment, and sign the informed consent.

Exclusion Criteria

• Significant hepatic or renal dysfunction;
• Patients with malignant tumors other than prostate cancer within 2 years;
• Ready to pregnant;
• The patient can not tolerate all clinical tests.

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

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Hua Zhu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Duan X, Cao Z, Zhu H, Liu C, Zhang X, Zhang J, Ren Y, Liu F, Cai X, Guo X, Xi Z, Pomper MG, Yang Z, Fan Y, Yang X. 68Ga-labeled ODAP-Urea-based PSMA agents in prostate cancer: first-in-human imaging of an optimized agent. Eur J Nucl Med Mol Imaging. 2022 Feb;49(3):1030-1040. doi: 10.1007/s00259-021-05486-x. Epub 2021 Aug 28.

Reference Type: DERIVED

PMID: 34453203 (View on PubMed)

Other Identifiers

2020KT107

Identifier Type: -

Identifier Source: org_study_id