Observational Study for Clinically Significant Prostate Cancer Diagnosis
This study is looking into a new way to diagnose clinically significant prostate cancer (csPCa), which is a type of prostate cancer that needs treatment. Researchers are investigating a "plasma exosome RNA signature," which means they are looking at specific genetic material found in your blood to see if it can help identify this cancer. You might be able to join if you are a man aged 18 or older, have a blood prostate-specific antigen (PSA) level above 4 ng/dl, and your doctor suspects you might have prostate cancer based on symptoms or tests like a digital rectal exam, ultrasound, or MRI. You must also be willing to have a prostate biopsy. The main goal is to see how well this blood test can diagnose csPCa at the time of your prostate biopsy. The study aims to include about 1700 participants.
- Study design
- This is an observational study, meaning researchers will observe and collect information without giving any specific treatment. It plans to enroll about 1700 men.
- What's involved
- You would need to have a blood test and be willing to undergo a prostate biopsy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The diagnostic efficacy is measured at the time of prostate biopsy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer
At a glance
Conditions
Where it's being run
10 sites across 6 statesStudy leadership
- Weijun Qin, MD. · STUDY_CHAIR · Xijing Hospital
Who to contact
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What this trial measures
- The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing csPCaThe time of prostate biopsy
The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing clinically significant prostate cancer (csPCa) and evaluate its sensitivity and specificity in diagnosing csPCa. Descriptive statistics were calculated and presented as the frequency (percentage) for categorical variables, the mean (standard deviation) for continuous variables with a normal distribution, and the median (quartile) for continuous variables with a skewed distribution. Two-sample t-tests were used to assess continuous variables with a normal distribution, and the Wilcoxon signed-rank test was used to assess continuous variables with a skewed distribution. The Mann-Whitney U test was used to compare means from two samples. The correlation between two samples was analyzed by Spearman's ρ test. The receiver operating characteristic (ROC) curve was used to determine the cutoff value of exo-RNA panel for diagnosing patients with csPCa.