NCT04521894

The Application Value of 18F-prostate-specific Membrane Antigen PET/CT in Prostate Cancer

Status unknown Last updated 9 June 2023

What this trial tests

trial testing Positron emission tomography/computerized tomography (PET/CT) in Prostatic Neoplasms in 500 participants. Status unknown.

Timeline

22 August 2021

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	First Affiliated Hospital Xi'an Jiaotong University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	500
Start date	22 August 2021
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	1 location across China

Drugs / interventions tested

• Positron emission tomography/computerized tomography (PET/CT)

Conditions studied

• Prostatic Neoplasms — all drugs for Prostatic Neoplasms →

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Who can join

Adults 40 to 100, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prostate cancer (PCa) is the most common type of malignant tumor and the third leading cause of cancer-associated mortality among men worldwide. The biological behaviors of PCa at different degrees of malignancy also largely differ, directly impacting disease outcomes and responses to treatment. Therefore, accurate risk stratification of PCa before treatment and the development of an individualized treatment regimen, play a vital role to improve the clinical outcome of patients. However, overdiagnosis and unnecessary biopsies, which are invasive examinations associated with higher costs and adverse effects. When the PSA is less than 20ng/mL, less than 1% of PCa patients have a positive bone scan, and routine bone scans are not recommended for asymptomatic or low-risk PCa patients. Interestingly, due to the variations among evaluators that often occur when defining the T stage, biopsies operate inaccuracy, also low-PSA level can also occur metastasis, there is a need for an objective and accurate imaging biomarker for the diagnosis of different grade PCa.

Prostate-specific membrane antigen (PSMA) is a type II transmembrane protein, which has higher expression in cancerous prostate cells than in normal prostate cells. Meanwhile, its expression level is positively correlated with the degree of malignancy, the tendency of metastasis, and the risk of early recurrence. In recent years, 18F-PSMA positron emission tomography/computerized tomography (PSMA PET/CT) has earned widespread attention as a novel imaging modality based on molecular-level analysis, rather than morphological or physiological analysis, to assist in PCa diagnosis and tumor burden evaluation.

Currently, Maximum Standardized Uptake Value (SUVmax) is the most commonly used semi-quantitative parameter in PET/CT, which is used to assess tumor burden of PCa, and thus can be used as an imaging biomarker to assess the degree of malignancy of prostate cancers. However, prior studies mainly focused on the correlation between patients' biochemical recurrence lesions and the PSA levels and Gleason score. There is a lack of research to explore the correlation among primary PCa burden, PSA levels, and the degree of prostate cancer malignancy. The aim of this project is to use 18F-PSMA PET/CT SUVmax to analyze the correlation among primary PCa imaging, and clinical indicators, and to evaluate the predictive value for PCa risk stratification, metastasis risk, and biochemical recurrence.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluating the value of ¹⁸F-PSMA-1007 PET/CT in the detection and identification of prostate cancer using histopathology as the standard.
   Luo L, Zheng A, Chang R, Li Y, et al · · 2023 · cited 7× · PMID 37924154 · DOI 10.1186/s40644-023-00627-x