Prostatic Neoplasms Clinical Trial
Official title:
Diagnostic Performance of 18F-prostate-specific Membrane Antigen-1007 PET/CT in the Detection of Prostate Cancer
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 40 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | First Affiliate Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SUVmax | 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. | From the time the participants first go to the hospital without treatment and through study completion, an average of 1 year. If the patient undergoes radical prostatectomy, an additional scan will be added within 1 month after surgery | |
Primary | PSA | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. | Through study completion, an average of 6 months | |
Primary | Gleason Score | The cells are graded on a scale of 1 to 5. Grade 1 cells resemble normal prostate tissue. Cells closest to 5 are considered "high-grade" and have mutated so much that they barely resemble normal cells. | Baseline of the study by prostate cancer biopsies or after radical prostatectomy, and when there is a biochemical recurrence, an additional biopsies the prostate bed within 1 month. | |
Secondary | BMI | Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness. BMI can be used to screen for weight categories that may lead to health problems but it is not diagnostic of the body fatness or health of an individual. | Through study completion, an average of 6 months. |
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