Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

500

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

August 17, 2020

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed

1 year until next milestone

Study Start

First participant enrolled

August 22, 2021

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed

Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

August 17, 2020

Last Update Submit

June 7, 2023

Conditions

Prostatic Neoplasms

Keywords

Prostate-specific antigenPET/CTPSMAGleason Score

Outcome Measures

Primary Outcomes (3)

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
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
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 Outcomes (1)

BMI
Through study completion, an average of 6 months.

Study Arms (5)

Primary PCa without metastases Group

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.