Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Al18F-PSMA-617; Drug: 68Ga-PSMA-617

Study type: Interventional

Funder types: Other

Identifiers

NCT05841992

PekingUMCHFPSMA617

Details and patient eligibility

About

18F-labeled prostate-specific membrane antigen (PSMA) ligand-positron emission tomography (PET) offers advantages over 68Ga-labeled PSMA ligands. Al18F-PSMA-617 is a novel 18F-PSMA compound used for prostate cancer (PCa) imaging. This pilot study was prospectively designed to compare the lesion detectability of Al18F-PSMA-617 and related 68Ga-PSMA-617 PET/CT in patients with PCa

Full 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. Al18F-PSMA-617 is a novel radiopharmaceutical targeting PSMA. Liu T et.al had demonstrated that Al18F-PSMA-617 accumulates specifically in PSMA-positive tumors with high binding affinity and selectivity. The first in-human evaluation of Al18F-PSMA-617 in a small PCa sample size also confirmed the good detectability of tumor lesions. This pilot study was prospectively designed to evaluate the early dynamic distribution of Al18F-PSMA-617 compared with 68Ga-PSMA-617 in the same group of prostate cancer patients.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed untreated prostate cancer patients;

  • 68Ga-PSMA617 and Al18F-PSMA-617 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CTscan

Experimental group

Description:

Patients of Prostate cancer PET/CT imaging: In two consecutive days each patient underwent a PET/CT scan after intravenous administration of 68Ga-PSMA617 and Al18F-PSMA-617, respectively.

Treatment:

Drug: 68Ga-PSMA-617

Drug: Al18F-PSMA-617