Prostate Cancer
Conditions
Keywords
Prostate cancer, RNA, Diagnosis, Combination
Brief summary
The aim of the present study is to investigate a RNA combination to diagnose prostate cancer.
Interventions
DIAGNOSTIC_TESTProstate cancer screening decision
The subjects would receive serum PSA test.
Sponsors
Xijing Hospital
Shaanxi Provincial People's Hospital
Yan'an University Affiliated Hospital
Weinan Central Hospital
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Affiliated Hospital of Qinghai University
General Hospital of Ningxia Medical University
LanZhou University
Air Force 986 Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Blood prostate-specific antigen PSA\>4ng/dl; 2. Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging, and PSMA PET/CT examination. 3. The patient is willing to undergo prostate biopsy.
Exclusion criteria
1. Previous diagnosis of prostate cancer through prostate biopsy; 2. History of other malignant tumors in the past two years; 3. According to the research physician\'s judgment, serious complications may occur and affect the normal conduct of the experiment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa | The time of prostate biopsy and after 6 months follow-up | The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing prostate cancer and evaluate its sensitivity and specificity in diagnosing PCa. 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 PCa. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa, insignPCa and its comparison with other imaging methods or blood tests | The time of prostate biopsy and after 6 months follow-up | The secondary outcome is to evaluate the positive predictive value (PPV), negative predictive value (NPV) and accuracy of exo-RNA panel in detection of PCa; to evaluate the perforamce of exo-RNA panel in identifying grade group 2 (GG2) or higher clinically significant prostate cancer (csPCa) tumors and compare the diagnostic performance of the plasma-exosome RNA panel with other imaging methods or blood tests in identifying prostate cancer patients; Whether the exo-RNA panel could predict the PCa patients with higher Gleason score (GS). The comparison between diagnostic performance of exo-RNA panel and other imaging or blood tests is performed in ROC curves. The ICC analysis was performed by reliability analysis. All statistical analyses were conducted using IBM SPSS statistics software, version 23.0 (IBM, Inc., Chicago, IL, USA) and GraphPad Prism software, version 8.0 (GraphPad Software, Inc., La Jolla, CA, USA). |
Countries
China
Outcome results
None listed