Clinical trial · Observational
The Application Value of 18F-prostate-specific Membrane Antigen PET/CT in Prostate Cancer
Diagnostic Performance of 18F-prostate-specific Membrane Antigen-1007 PET/CT in the Detection of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Positron emission tomography/computerized tomography (PET/CT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Primary PCa without metastases Group
- description
- Participants who are suspected of prostate cancer due to elevated PSA or clinical symptoms but have not received any treatment and eventually confirmed prostate cancer after surgery or biopsies.
- interventionNames
- Device: Positron emission tomography/computerized tomography (PET/CT)
- label
- Primary PCa with metastases Group
- description
- Participants who are suspected of prostate cancer due to elevated PSA or clinical symptoms but have not received any treatment and eventually confirmed prostate cancer after surgery or biopsies. And the 18F-PSMA-PET/CT scan confirmed metastases.
- interventionNames
- Device: Positron emission tomography/computerized tomography (PET/CT)
- label
- Oligometastatic PCa group
- description
- "Oligometastatic"is a subgroup of metastatic patients with a limited number of secondary lesions (threshold ranging from 3 to 5) in one or few organs.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 1 age between 40 and 100 years old * 2 PSA \>0.4 ng/mL for primary PCa with biopsy proven or RP diagnosis of prostate cancer * 3 PSA \>0.2 ng/mL after RP, PSA ≥2 ng/mL above the nadir after EBRT) or persisting PSA after radical treatment with rising PSA values * 4 complete clinical, pathological, imaging and biochemical information Exclusion Criteria: * 1 lack of histological examinationproven diagnosis of PCa * 2 18F-PSMA PET/CT being performed after pharmacotherapy since PSMA-targeted imaging can be disturbed by previous therapie
References
Publications (1)
- DERIVEDLuo L, Zheng A, Chang R, Li Y, Gao J, Wang Z, Duan X. Evaluating the value of 18F-PSMA-1007 PET/CT in the detection and identification of prostate cancer using histopathology as the standard. Cancer Imaging. 2023 Nov 3;23(1):108. doi: 10.1186/s40644-023-00627-x. PMID 37924154