Clinical trial · Interventional
Plasma Exosome RNA to Diagnose Prostate Cancer
Plasma Exosome RNA Combination for Diagnosing Prostate Cancer: a Prospective, Multicenter Diagnostic Trial
NCT06604130CI-TRIAL-00119929exo-PRECISEenrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the present study is to investigate a RNA combination to diagnose prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate cancer screening decision | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- The experimental arm receiving diagnosis from serum RNA combination
- interventionNames
- Diagnostic Test: Prostate cancer screening decision
Primary outcomes (1)
- measure
- The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa
- timeFrame
- The time of prostate biopsy and after 6 months follow-up
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.