Intratumoral Heterogeneity on [18F]PSMA and [18F]FDG PET/CT in Predicting Invasion and Prognosis of Prostate Cancer

NCT06919159 | Completed

• 1 other identifier: [2020]388
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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)

Conditions

Prostate Cancer (Diagnosis); Prostate-specific Membrane Antigen; Positron Emission Tomography (PET)

Keywords

Fluorine-18-fluorodeoxyglucose; Heterogeneity

Outcome Measures

Primary Outcomes (1)

• The relationship between imaging phenotypes and gleason score (GS)

  From enrollment to the end of 1 month inspection

Study Arms (4)

double positive group

patients with one type of PSMA+/FDG+ homogeneous segment

Diagnostic Test: PSMA PET/CT scan; Diagnostic Test: FDG-PET

double negative group

patients with one type of PSMA-/FDG- homogeneous segment

Diagnostic Test: PSMA PET/CT scan; Diagnostic Test: FDG-PET

PSMA predominant group

patients with one type of PSMA+/FDG- heterogeneous segment

Diagnostic Test: PSMA PET/CT scan; Diagnostic Test: FDG-PET

FDG predominant group

patients with one type of PSMA-/FDG+ heterogeneous segment

Diagnostic Test: PSMA PET/CT scan; Diagnostic Test: FDG-PET

Interventions

PSMA PET/CT scan DIAGNOSTIC_TEST

Different developing agents

FDG predominant group; PSMA predominant group; double negative group; double positive group

FDG-PET DIAGNOSTIC_TEST

Different developing agents

FDG predominant group; PSMA predominant group; double negative group; double positive group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects treated at the First Affiliated Hospital of China Medical University

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jiequn Yu: lead

Study Sites (1)

Department of Nuclear Medicine, The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xuena Li, PhD

  First Hospital of China Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: July 1, 2021
• Primary Completion: November 20, 2022
• Study Completion: November 30, 2022
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

CN (1)