Clinical trial NCT06919159: Intratumoral Heterogeneity on [18F]PSMA and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Prostate Cancer
Official title: Intratumoral Heterogeneity on [18F]PSMA-1007 and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Primary Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer (Diagnosis)
Prostate-specific Membrane Antigen
Positron Emission Tomography (PET)
Keywords: Fluorine-18-fluorodeoxyglucose
Heterogeneity
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects treated at the First Affiliated Hospital of China Medical University

Brief summary: The purpose of this study is to analyze heterogeneity of prostate cancer（PCa）based on the head-to-head imaging of prostate-specific membrane antigen (PSMA) and fluorodeoxyglucose (FDG) positron emission tomography computed tomography (PET/CT)

Detailed description: PET/CT examinations were performed on different days using Siemens Biograph MCT PET/CT equipment. All patients were examined on the same scanner. Patients were fasted for more than 6 h before \[18F\]FDG PET/CT examination, blood glucose was controlled below 11.1 mmol/L, \[18F\]FDG injection dose was 3.7 MBq/kg, and \[18F\]FDG PET/CT examination was performed after 60 min rest. \[18F\]PSMA-1007 injection dose was 3.7 MBq/kg, and PET/CT scan was performed 60 min after injection. To avoid interference of prostate lesion detection by active urine in the bladder, patients were asked to urinate or undergo forced diuresis before the start of the examination. The scan was performed from the top of the head to the base of the thighs. Low-dose CT was taken with automatic milliampere-second 120 kV voltage scans with a matrix of 512 × 512 and a thickness of 5 mm, and PET/CT image acquisition was taken from 5-6 beds for 2-3 min each. CT data was used for attenuation correction at the end of the acquisition, reconstructed by the two-iteration method (21 subsets in total), and the True X +TOF algorithm was applied to reconstruct the images. Two nuclear medicine physicians with extensive experience in PET/CT interpretation evaluated the images using the LIFEx software v 7.1.0. Both readers were blinded to both clinical and pathological data

Eligibility criteria: Inclusion Criteria:

* Untreated patients with PCa confirmed by prostate systemic pathological biopsy
* Patients underwent \[18F\]PSMA-1007 and \[18F\]FDG PET/CT and the imaging interval was less than one month.

Exclusion Criteria:

* Patients received treatment at intervals of two imaging
* Imaging was less than 1 week after pathology biopsy

Primary outcomes:
measure: The relationship between imaging phenotypes and gleason score (GS)
timeFrame: From enrollment to the end of 1 month inspection
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Nuclear Medicine, The First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Xuena Li, PhD
role: STUDY_DIRECTOR
References: