Plasma Exosome RNA to Diagnose Prostate Cancer (exo-PRECISE)

Plasma Exosome RNA Combination for Diagnosing Prostate Cancer: a Prospective, Multicenter Diagnostic Trial

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Prostate cancer screening decision

• Study Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
  • Ningxia
    • Yinchuan, Ningxia, China, 750000
      • General Hospital of Ningxia Medical University
  • Qinghai
    • Xining, Qinghai, China, 810000
      • Qinghai University Affiliated Hospital
  • Shaanxi
    • Weinan, Shaanxi, China, 714000
      • Weinan Central Hospital
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital
    • Xi'an, Shaanxi, China, 710000
      • Shaanxi provincial people's hospital
    • Xi'an, Shaanxi, China, 710000
      • Xijing 986 Hospital
    • Xianyang, Shaanxi, China, 712000
      • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
    • Yan’an, Shaanxi, China, 716000
      • Affiliated Hospital of Yan'an University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental arm receiving diagnosis from serum RNA combination	Diagnostic test: Prostate cancer screening decision; The subjects would receive serum PSA test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa, insignPCa and its comparison with other imaging methods or blood tests	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).	The time of prostate biopsy and after 6 months follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Prostate cancer; Diagnosis; Combination; RNA
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Disease
• Other Study ID Numbers: KY20242271-C-1; NSFC(China) (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The subjects may not disclose their IPD totally or partly.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No