Plasma Exosome RNA to Diagnose Prostate Cancer

NCT06604130 | Enrolling By Invitation DMC

• 2 other identifiers: KY20242271-C-1NSFC(China)
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Prostate cancer; RNA; Diagnosis; Combination

Outcome Measures

Primary Outcomes (1)

• The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa

  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.

  The time of prostate biopsy and after 6 months follow-up

Secondary Outcomes (1)

• 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

Study Arms (1)

The experimental arm receiving diagnosis from serum RNA combination

EXPERIMENTAL

Diagnostic Test: Prostate cancer screening decision

Interventions

Prostate cancer screening decision DIAGNOSTIC_TEST

The subjects would receive serum PSA test.

The experimental arm receiving diagnosis from serum RNA combination

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Blood prostate-specific antigen PSA\>4ng/dl;
• Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging, and PSMA PET/CT examination.
• The patient is willing to undergo prostate biopsy.

You may not qualify if:

• Previous diagnosis of prostate cancer through prostate biopsy;
• History of other malignant tumors in the past two years;
• According to the research physician\'s judgment, serious complications may occur and affect the normal conduct of the experiment

Sponsors & Collaborators

• Xijing Hospital: lead
• Shaanxi Provincial People's Hospital: collaborator
• Yan'an University Affiliated Hospital: collaborator
• Weinan Central Hospital: collaborator
• The Second Affiliated Hospital of Shaanxi University of Chinese Medicine: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• General Hospital of Ningxia Medical University: collaborator
• LanZhou University: collaborator
• Air Force 986 Hospital: collaborator

Study Sites (9)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750000, China

Location

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

Location

Weinan Central Hospital

Weinan, Shaanxi, 714000, China

Location

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710000, China

Location

Xijing 986 Hospital

Xi'an, Shaanxi, 710000, China

Location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xianyang, Shaanxi, 712000, China

Location

Affiliated Hospital of Yan'an University,

Yan’an, Shaanxi, 716000, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: March 12, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CN (9)