Prostate Cancerexo-PRECISENCT06604130
Plasma Exosome RNA to Diagnose Prostate Cancer
A study testing Prostate cancer screening decision in people with Prostate Cancer, run by Xijing Hospital at 9 sites in China.
Trial summary
The aim of the present study is to investigate a RNA combination to diagnose prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate cancer screening decision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 9 sitesChina
- Study dates
- 12 Mar 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Weinan Central Hospital
Weinan, Shaanxi, 714000
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710000
Xijing 986 Hospital
Xi'an, Shaanxi, 710000
Xijing Hospital
Xi'an, Shaanxi, 710032
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, 712000
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Affiliated Hospital of Yan'an University,
Yan’an, Shaanxi, 716000
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750000
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Prostate cancer screening decision
- Keywords
- Prostate cancer, RNA, Diagnosis, Combination
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate cancer screening decisionDiagnostic test
The subjects would receive serum PSA test.
| Study group | Role | What they receive |
|---|---|---|
| The experimental arm receiving diagnosis from serum RNA combination | Experimental | Not described Receives: Diagnostic Test: Prostate cancer screening decision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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).
Measured: The time of prostate biopsy and after 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Mar 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604130
- Sponsor's protocol ID
- KY20242271-C-1
- Other IDs
- NSFC(China)
- Acronym
- exo-PRECISE
- Status last verified
- Nov 2025
- First submitted
- 13 Sep 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The subjects may not disclose their IPD totally or partly.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Exosome RNA Combination for Diagnosing Prostate Cancer: a Prospective, Multicenter Diagnostic Trial
- ClinicalTrials.gov ID
- NCT06604130
- Acronym / sponsor ID
- exo-PRECISE / KY20242271-C-1
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, RNA, Diagnosis, Combination
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- 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 start
- 12 Mar 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to investigate a RNA combination to diagnose prostate cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The experimental arm receiving diagnosis from serum RNA combination | Experimental | Diagnostic Test: Prostate cancer screening decision |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate cancer screening decisionThe subjects would receive serum PSA test. | Diagnostic test | The experimental arm receiving diagnosis from serum RNA combination |
Primary outcome
The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa
Time frame: 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.
1 secondary outcome
Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa, insignPCa and its comparison with other imaging methods or blood tests
Time frame: The time of prostate biopsy and after 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided. The subjects may not disclose their IPD totally or partly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate cancer screening decision in people with Prostate Cancer, run by Xijing Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa (time frame: The time of prostate biopsy and after 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.