Plasma Exosome RNA to Diagnose Prostate Cancer

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: Prostate cancer screening decision

• Registration Number: NCT06604130
• Lead Sponsor: Xijing Hospital

Brief Summary

The aim of the present study is to investigate a RNA combination to diagnose prostate cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-12
• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
The experimental arm receiving diagnosis from serum RNA combination	Prostate cancer screening decision	-

Primary Outcome Measures

Name	Time	Method
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 diagnositc efficacy, sensitivity, specificity, positive predictive value(PPV), negative predictive value (NPV) and accuracy 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 Outcome Measures

Name	Time	Method
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 evaluating the perforamce of exo-RNA panel in identifying grade group 2 (GG2) or higher clinically significant prostate cancer (csPCa) tumors, clinically insignificant PCa (insignPCa; GG1), 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). All hypothesis tests were two-sided, and P \< 0.05 was considered to indicate statistical significance.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xian, Shaanxi, China