Clinical trial NCT05841992: Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients
Official title: Comparison of the Detection Efficiencies of Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time-activity curves
timeFrame: through study completion, an average of 1 year
measure: Kinetic parameters
timeFrame: through study completion, an average of 1 year
measure: Differences in lesion detection at different imaging time point
timeFrame: through study completion, an average of 1 year
measure: Diagnostic value
timeFrame: hrough study completion, an average of 1 year
Secondary outcomes:
measure: SUVmax of tumor
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Li Huo, MD
role: PRINCIPAL_INVESTIGATOR
References: