Clinically Significant Prostate CancerNCT07492927
Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer
An observational study of Clinically Significant Prostate Cancer, run by Xijing Hospital at 10 sites in 2 countries.
Trial summary
The aim of the present study is to investigate a plasma exosome RNA signature to diagnose clinically significant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Clinically Significant Prostate Cancer
- How many people
- 1,700 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 12 Mar 2021to 30 Jun 2027
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The men with suspected prostate cancer
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.
- 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
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
China9 sites, 9 recruiting
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
+86 0931 8625200, zhw6461@163.com
Wei Zhang, MD.
- Recruiting
Weinan Central Hospital
Weinan, Shaanxi
Weihong Zhao, MD., +86 0913 2168587, 513861803@qq.com
Weihong Zhao, MD.
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi
Yi Sun, MD., +86 85251331, adoremidfall@163.com
Yi Sun, MD.
- Recruiting
Xijing 986 Hospital
Xi'an, Shaanxi
Wuhe Zhang, MD., +86 029 84776225, zwh74129@126.com
- Recruiting
Xijing Hospital
Xi'an, 710032
Jianhua Jiao, MD., +86 029 84771062, 1531769428@qq.com
- Recruiting
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi
Wei Zheng, MD., +86 029 33572527, mnzhengwei1978@163.com
Wei Zheng, MD.
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai
Guojun Chen, MD., +86 0971 6162000, chenguojun68@126.com
Guojun Chen, MD.
- Recruiting
Yan'an University Affiliated Hospital
Yan’an, Shaanxi
Jixue Gao, MD., +86 0911 2856010, gjxsnowmo@126.com
Jixue Gao, MD.
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Zhiyong Lv, MD., +86 0951 6744457, lvlu1996@sina.com
Zhiyong Lv, MD.
United States1 site, 1 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Qiang Zhang, MD., +1 312 503 2891, q-zhang2@northwestern.edu
Qiang Zhang, MD.
About this study
The aim of the present study is to investigate a plasma exosome RNA signature to diagnose clinically significant prostate cancer.
- Conditions
- Clinically Significant Prostate Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | The experimental arm receiving diagnosis from serum RNA combination |
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 csPCa
The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing clinically significant prostate cancer (csPCa) and evaluate its sensitivity and specificity in diagnosing csPCa.
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 csPCa.
Measured: The time of prostate biopsy
Secondary outcomes (1)
Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa 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 csPCa; 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start12 Mar 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Significant 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shaanxi Provincial People's Hospital, Weinan Central Hospital, Shaanxi University of Chinese Medicine, LanZhou University, Qinghai University, Ningxia Medical University, Northwestern University, Yan'an University Affiliated Hospital, Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Weijun Qin, MD., Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492927
- Sponsor's protocol ID
- KY20262014-F-1
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07492927
- Acronym / sponsor ID
- KY20262014-F-1
- Conditions
- Clinically Significant Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Shaanxi Provincial People's Hospital, Weinan Central Hospital, Shaanxi University of Chinese Medicine, LanZhou University, Qinghai University, Ningxia Medical University, Northwestern University, Yan'an University Affiliated Hospital, Air Force Military Medical University, China
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Mar 2026 (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 plasma exosome RNA signature to diagnose clinically significant prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | –The experimental arm receiving diagnosis from serum RNA combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The men with suspected prostate cancer
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.
- 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.
Primary outcome
The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing csPCa
Time frame: The time of prostate biopsy
The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing clinically significant prostate cancer (csPCa) and evaluate its sensitivity and specificity in diagnosing csPCa. 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 csPCa.
1 secondary outcome
Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa and its comparison with other imaging methods or blood tests
Time frame: The time of prostate biopsy
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 25 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Weijun Qin, MD. study chair
Xijing Hospital
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinically Significant Prostate Cancer, run by Xijing Hospital at 10 sites in 2 countries.
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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, United States. 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?
Contact Jianhua Jiao, MD. (+86 029 84771062, 1531769428@qq.com), or a site near the patient. 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 csPCa (time frame: The time of prostate biopsy). 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 25 Mar 2026.