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

NCT04521894 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-06-09

No results posted yet for this study

Summary

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.

Conditions

  • Prostatic Neoplasms

Interventions

DEVICE

Positron emission tomography/computerized tomography (PET/CT)

1. Genetic factors and age: Epidemiological studies have shown that if an immediate family member (brother or father) suffers from prostate cancer, the risk of prostate cancer will be more than doubled. Age is a relatively strong risk factor for PCa. 2. Prostatitis: Prostatitis is related to PCa. Cancer is usually found in the tissues where inflammation is found. 3. Obesity: Research has found that obese patients have a low grade of PCa, but their risk of developing aggressive cancer is higher. 4. Infection: 5. Exercise: Most studies have found that exercise does not reduce the risk of prostate cancer, but some studies have shown that. 6. Daily diet: The corrective mechanism of diet in PCa is not very clear. 7. Drinking history:

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Xiaoyi Duan, Ph.D. · First Affiliate Hospital of Xi'an Jiaotong University

Eligibility

Min Age
40 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-22
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04521894 on ClinicalTrials.gov