Prostate Cancer (Diagnosis)NCT07755592
miRNA Panel for PCa Diagnosis
An observational study of Prostate Cancer (Diagnosis), run by RenJi Hospital at 1 site in China.
Trial summary
This is a single-center, prospective diagnostic accuracy trial conducted at Renji Hospital, Shanghai Jiao Tong University School of Medicine, led by a team of urology and molecular medicine researchers. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis)
- What is being tested?
- Serum microRNA panel detection for prostate lesion differentiation
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2026to 1 Dec 2027
- How long will I take part?
- 30 Days
- 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: Male patients aged 18 years or older visiting the urology outpatient department of Renji Hospital, Shanghai Jiao Tong University School of Medicine, with clinical indications for prostate biopsy due to suspected prostate lesions. Eligible patients present with abnormal PSA levels, abnormal digital rectal examination, suspicious mpMRI/TRUS/PSMA PET/CT findings, positive prostate cancer family history, or pathogenic prostate cancer-related gene mutations. A total of 500 participants will be enrolled, who will undergo transrectal ultrasound-guided prostate biopsy as the diagnostic gold standard to classify them into prostate cancer and benign prostatic hyperplasia subgroups.
Who may be able to join
- Male participants aged ≥18 years Serum PSA > 4.0 ng/mL confirmed by repeat testing with ≥4-week interval, excluding interfering conditions such as acute urinary retention, catheterization and prostatitis PSA within gray zone (4.0-10.0 ng/mL) accompanied by abnormal f/t PSA ratio <0.16, PSAD >0.15 ng/mL/g or PSAV >0.75 ng/mL/year Persistently rising PSA on two consecutive tests with abnormal PSAV regardless of absolute PSA value Abnormal digital rectal examination (DRE): palpable hard, nodular, fixed or asymmetric prostate lesions, indistinct induration or suspected space-occupying lesions Suspicious transrectal ultrasound (TRUS): hypoechoic nodules, hypervascular areas or disrupted prostatic capsule mpMRI PI-RADS v2.1 score ≥3, especially lesions scoring 4-5 Elevated focal PSMA uptake on PSMA PET/CT (if performed) First-degree relative with prostate cancer and personal PSA >3.0 ng/mL Carriers of pathogenic BRCA1/2, HOXB13 mutations with PSA >3.0 ng/mL Prior negative prostate biopsy with subsequent sustained PSA elevation or new suspicious mpMRI lesions Unexplained bone pain or pathological fracture with elevated PSA requiring exclusion of primary prostate malignancy Aggravated bladder outlet obstruction with elevated PSA or abnormal DRE requiring differentiation of malignant obstruction
Who cannot join
- Confirmed prostate cancer receiving radical surgery, radiotherapy, androgen deprivation therapy or active surveillance Acute bacterial prostatitis, febrile urinary tract infection or acute urinary retention within the preceding 4 weeks Prostate massage, cystoscopy, ejaculation within 72 hours; prostate biopsy within 6 weeks; transurethral prostate surgery within 3 months prior to screening Active concurrent malignancy or history of any malignant tumor within the past 5 years (non-melanoma skin cancer excluded) Severe Child-Pugh grade C liver dysfunction, eGFR <30 mL/min/1.73m², coagulopathy (INR >1.5 or platelet count <50×10⁹/L) Unable to discontinue anticoagulants (warfarin, dabigatran, rivaroxaban) or dual antiplatelet therapy for ≥5 days Severe cognitive impairment or acute psychiatric disorder precluding independent informed consent, follow-up and biospecimen collection Participation in other interventional clinical trials within 3 months or concurrent observational trials interfering with study outcomes Hematological disorders including myelodysplastic syndrome and leukemia that alter serum nucleic acid stability Severe peripheral vascular disease hindering venipuncture or inability to comply with fasting blood collection requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
Wei Xue, Phd, 8621-58752345, uroxuewei@163.com
About this study
Official title: Efficacy Exploration of Non-Invasive Diagnostic Strategies for Prostate Cancer (PCa) and Benign Prostatic Hyperplasia (BPH) Based on Body Fluid miRNA Panels: A Prospective Diagnostic Study
This is a single-center, prospective diagnostic accuracy trial conducted at Renji Hospital, Shanghai Jiao Tong University School of Medicine, led by a team of urology and molecular medicine researchers. A total of 500 male participants aged 18 years or older who meet clinical indications for prostate biopsy will be enrolled between May 2026 and May 2027. All participants have suspected prostate cancer (PCa) based on abnormal prostate-specific antigen (PSA), abnormal digital rectal examination (DRE), suspicious multiparametric MRI (mpMRI), positive family history of prostate cancer, pathogenic gene mutations, or other high-risk clinical findings. Men with confirmed treated prostate cancer, recent prostate-related procedures, active other malignancies, severe organ dysfunction, coagulation disorders, or cognitive impairment that prevents informed consent will be excluded.
The core goal of this study is to test the diagnostic performance of a novel non-invasive blood test using a panel of circulating microRNAs (miRNAs) from serum, and compare it with the standard PSA-based screening tools to distinguish prostate cancer from benign prostatic hyperplasia (BPH). The gold standard for judging true disease status will be pathology results from transrectal ultrasound-guided prostate biopsy. Researchers will calculate key diagnostic metrics including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve (AUC) for the miRNA panel. Secondary analyses will evaluate whether combining the miRNA signature with PSA or mpMRI improves diagnostic accuracy, especially for men with PSA levels in the ambiguous "gray zone" of 4-10 ng/mL. Subgroup assessments will also test how well the miRNA panel differentiates low-risk versus high-risk prostate cancer and clinically significant versus insignificant tumors across different PSA tiers, age groups, mpMRI risk scores and prostate sizes. Additional laboratory testing will confirm the stability of serum miRNAs under different storage temperatures and storage durations, as well as test consistency across operators, reagent batches and detection platforms to validate real-world clinical usability.
Read more
For participants, the study only involves a one-time fasting venous blood draw of up to 10 mL before biopsy, with no extra invasive procedures or experimental medications added to routine clinical care. The free miRNA test results can serve as supplementary evidence to help doctors judge whether a prostate biopsy is truly necessary, potentially sparing many patients from unnecessary invasive biopsy and its associated discomfort or complications. All blood samples will be stored under standardized biosafety protocols with de-identified personal data to fully protect participant privacy. Minimal risks include minor temporary bruising or slight pain at the blood draw site, which resolve spontaneously without long-term harm.
Statistical analysis will use three defined datasets (full analysis set, per-protocol set, safety set) and advanced methods including DeLong's test, logistic regression, NRI and IDI to quantify diagnostic improvement versus PSA. A 70% training cohort will build the miRNA diagnostic model, and the remaining 30% of samples will act as an independent validation group to verify model reliability. Safety monitoring will record all adverse events throughout follow-up, with strict ethical oversight following the Declaration of Helsinki and Chinese biomedical research regulations. After sample testing, data analysis and result summarization finish by October 2027, the research team plans to publish 1-2 peer-reviewed SCI papers to share findings globally. If validated, this serum miRNA panel will provide a more precise, non-invasive screening tool to reduce overdiagnosis and unnecessary prostate biopsies, optimize early prostate cancer detection, and lower overall medical burdens for men at risk of prostate disease in clinical practice.
- Conditions
- Prostate Cancer (Diagnosis)
- Being tested
- Serum microRNA panel detection for prostate lesion differentiation
- Keywords
- Prostate cancer, BPH, miRNA, serum biomarker, diagnosis
- 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.
Serum microRNA panel detection for prostate lesion differentiationDiagnostic test
This diagnostic test quantitatively detects a custom panel of circulating microRNAs (miRNAs) extracted from fasting serum specimens collected from participants within 24 hours prior to transrectal ultrasound-guided prostate biopsy. Total RNA is isolated from serum samples, reverse-transcribed into cDNA, and quantified via quantitative real-time PCR (qRT-PCR). The miRNA expression signature is used to construct a logistic regression/machine learning diagnostic model, whose discriminatory performance is benchmarked against total PSA, f/t PSA ratio, and multiparametric MRI (mpMRI). Unique aspects of this test include: 1) systematic evaluation of miRNA stability under varied serum storage temperatures and storage durations; 2) assessment of inter-operator, inter-batch reagent, and inter-platform assay reproducibility via coefficient of variation (CV); 3) stratified performance testing across PSA gray zone (4-10 ng/mL), ISUP low/high-risk prostate cancer subgrou
| Study group | Role | What they receive |
|---|---|---|
| PCa cohort | Two diagnostic subgroups classified by histopathological gold standard from prostate biopsy:
Cohort 1: Participants diagnosed with prostate cancer (PCa) Cohort 2: Participants diagnosed with benign prostatic hyperplasia (BPH) and other non-malignant prostate lesions All 500 enrolled subjects originate from a single unified screening cohort of men with suspected prostate lesions meeting biopsy indications; post-biopsy pathological results allocate subjects into the above two analytical cohorts. Receives: Diagnostic Test: Serum microRNA panel detection for prostate lesion differentiation | |
| BPH cohort | Two diagnostic subgroups classified by histopathological gold standard from prostate biopsy:
Cohort 1: Participants diagnosed with prostate cancer (PCa) Cohort 2: Participants diagnosed with benign prostatic hyperplasia (BPH) and other non-malignant prostate lesions All 500 enrolled subjects originate from a single unified screening cohort of men with suspected prostate lesions meeting biopsy indications; post-biopsy pathological results allocate subjects into the above two analytical cohorts. Receives: Diagnostic Test: Serum microRNA panel detection for prostate lesion differentiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic curve (AUC) of serum miRNA panel for differentiating prostate cancer from benign prostatic hyperplasia
Evaluate the AUC, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the serum miRNA signature using transrectal ultrasound-guided prostate biopsy pathology as the diagnostic gold standard. Compare the miRNA panel's diagnostic performance against serum total PSA via DeLong test.
Measured: Completed after pathological diagnosis results of prostate biopsy are available for all enrolled participants, following serum miRNA laboratory testing and statistical analysis of the full study cohort.
Secondary outcomes (2)
Incremental diagnostic benefit of serum miRNA panel combined with PSA or mpMRI; stratified diagnostic performance across PSA subgroups and prostate cancer risk tiers
- Compare diagnostic gain of miRNA panel vs total PSA and f/t PSA via NRI and IDI; assess combined miRNA-PSA/mpMRI model accuracy especially for PSA gray zone (4-10 ng/mL). 2. Evaluate panel performance stability in PSA <4, 4-10, >10 ng/mL strata; distinguish low-risk (ISUP 1-2) vs high-risk (ISUP 3-5) and clinically significant/insignificant prostate cancer.
Measured: After completion of all biopsy pathology reports, serum miRNA testing and stratified subgroup statistical analyses of the full 500-subject cohort
Assay reproducibility and serum miRNA stability under different sample storage conditions
Calculate coefficient of variation (CV) across different operators, reagent batches and detection platforms. Detect miRNA expression changes in serum stored at room temperature, 4°C and -80°C over variable storage durations to verify clinical laboratory suitability.
Measured: Concurrent with batch serum miRNA laboratory testing throughout participant enrollment and sample processing phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start13 Apr 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies of the same condition, open and under way.
- 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
- 500 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Dong, RenJi Hospital
- Investigators
- Wei Xue, PhD, Principal investigator, RenJi HospitalPengfei Wang, MD, Principal investigator, RenJi HospitalLiang Dong, PhD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755592
- Sponsor's protocol ID
- LY2026-105-B
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing is undecided at present. All participant serum samples, raw miRNA detection data, clinical examination records and pathology reports contain sensitive personal clinical information and biospecimen-related private data protected by hospital biobank management regulations and Chinese personal information protection laws. The research team needs to complete data de-identification, formulate standardized data access agreements and obtain additional ethics committee approval before formalizing any data sharing scheme. No definitive IPD sharing policy has been finalized prior to completion of study enrollment, laboratory testing and statistical analysis.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Exploration of Non-Invasive Diagnostic Strategies for Prostate Cancer (PCa) and Benign Prostatic Hyperplasia (BPH) Based on Body Fluid miRNA Panels: A Prospective Diagnostic Study
- ClinicalTrials.gov ID
- NCT07755592
- Acronym / sponsor ID
- LY2026-105-B
- Conditions
- Prostate Cancer (Diagnosis)
- Keywords
- Prostate cancer, BPH, miRNA, serum biomarker, diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Aug 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.
This is a single-center, prospective diagnostic accuracy trial conducted at Renji Hospital, Shanghai Jiao Tong University School of Medicine, led by a team of urology and molecular medicine researchers. A total of 500 male participants aged 18 years or older who meet clinical indications for prostate biopsy will be enrolled between May 2026 and May 2027. All participants have suspected prostate cancer (PCa) based on abnormal prostate-specific antigen (PSA), abnormal digital rectal examination (DRE), suspicious multiparametric MRI (mpMRI), positive family history of prostate cancer, pathogenic gene mutations, or other high-risk clinical findings. Men with confirmed treated prostate cancer, recent prostate-related procedures, active other malignancies, severe organ dysfunction, coagulation disorders, or cognitive impairment that prevents informed consent will be excluded.
The core goal of this study is to test the diagnostic performance of a novel non-invasive blood test using a panel of circulating microRNAs (miRNAs) from serum, and compare it with the standard PSA-based screening tools to distinguish prostate cancer from benign prostatic hyperplasia (BPH). The gold standard for judging true disease status will be pathology results from transrectal ultrasound-guided prostate biopsy. Researchers will calculate key diagnostic metrics including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve (AUC) for the miRNA panel. Secondary analyses will evaluate whether combining the miRNA signature with PSA or mpMRI improves diagnostic accuracy, especially for men with PSA levels in the ambiguous "gray zone" of 4-10 ng/mL. Subgroup assessments will also test how well the miRNA panel differentiates low-risk versus high-risk prostate cancer and clinically significant versus insignificant tumors across different PSA tiers, age groups, mpMRI risk scores and prostate sizes. Additional laboratory testing will confirm the stability of serum miRNAs under different storage temperatures and storage durations, as well as test consistency across operators, reagent batches and detection platforms to validate real-world clinical usability.
For participants, the study only involves a one-time fasting venous blood draw of up to 10 mL before biopsy, with no extra invasive procedures or experimental medications added to routine clinical care. The free miRNA test results can serve as supplementary evidence to help doctors judge whether a prostate biopsy is truly necessary, potentially sparing many patients from unnecessary invasive biopsy and its associated discomfort or complications. All blood samples will be stored under standardized biosafety protocols with de-identified personal data to fully protect participant privacy. Minimal risks include minor temporary bruising or slight pain at the blood draw site, which resolve spontaneously without long-term harm.
Statistical analysis will use three defined datasets (full analysis set, per-protocol set, safety set) and advanced methods including DeLong's test, logistic regression, NRI and IDI to quantify diagnostic improvement versus PSA. A 70% training cohort will build the miRNA diagnostic model, and the remaining 30% of samples will act as an independent validation group to verify model reliability. Safety monitoring will record all adverse events throughout follow-up, with strict ethical oversight following the Declaration of Helsinki and Chinese biomedical research regulations. After sample testing, data analysis and result summarization finish by October 2027, the research team plans to publish 1-2 peer-reviewed SCI papers to share findings globally. If validated, this serum miRNA panel will provide a more precise, non-invasive screening tool to reduce overdiagnosis and unnecessary prostate biopsies, optimize early prostate cancer detection, and lower overall medical burdens for men at risk of prostate disease in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCa cohort | – | Diagnostic Test: Serum microRNA panel detection for prostate lesion differentiationTwo diagnostic subgroups classified by histopathological gold standard from prostate biopsy: Cohort 1: Participants diagnosed with prostate cancer (PCa) Cohort 2: Participants diagnosed with benign prostatic hyperplasia (BPH) and other non-malignant prostate lesions All 500 enrolled subjects originate from a single unified screening cohort of men with suspected prostate lesions meeting biopsy indications; post-biopsy pathological results allocate subjects into the above two analytical cohorts. |
| BPH cohort | – | Diagnostic Test: Serum microRNA panel detection for prostate lesion differentiationTwo diagnostic subgroups classified by histopathological gold standard from prostate biopsy: Cohort 1: Participants diagnosed with prostate cancer (PCa) Cohort 2: Participants diagnosed with benign prostatic hyperplasia (BPH) and other non-malignant prostate lesions All 500 enrolled subjects originate from a single unified screening cohort of men with suspected prostate lesions meeting biopsy indications; post-biopsy pathological results allocate subjects into the above two analytical cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients aged 18 years or older visiting the urology outpatient department of Renji Hospital, Shanghai Jiao Tong University School of Medicine, with clinical indications for prostate biopsy due to suspected prostate lesions. Eligible patients present with abnormal PSA levels, abnormal digital rectal examination, suspicious mpMRI/TRUS/PSMA PET/CT findings, positive prostate cancer family history, or pathogenic prostate cancer-related gene mutations. A total of 500 participants will be enrolled, who will undergo transrectal ultrasound-guided prostate biopsy as the diagnostic gold standard to classify them into prostate cancer and benign prostatic hyperplasia subgroups.
Key inclusion criteria (1 listed)
- Male participants aged ≥18 years Serum PSA > 4.0 ng/mL confirmed by repeat testing with ≥4-week interval, excluding interfering conditions such as acute urinary retention, catheterization and prostatitis PSA within gray zone (4.0-10.0 ng/mL) accompanied by abnormal f/t PSA ratio <0.16, PSAD >0.15 ng/mL/g or PSAV >0.75 ng/mL/year Persistently rising PSA on two consecutive tests with abnormal PSAV regardless of absolute PSA value Abnormal digital rectal examination (DRE): palpable hard, nodular, fixed or asymmetric prostate lesions, indistinct induration or suspected space-occupying lesions Suspicious transrectal ultrasound (TRUS): hypoechoic nodules, hypervascular areas or disrupted prostatic capsule mpMRI PI-RADS v2.1 score ≥3, especially lesions scoring 4-5 Elevated focal PSMA uptake on PSMA PET/CT (if performed) First-degree relative with prostate cancer and personal PSA >3.0 ng/mL Carriers of pathogenic BRCA1/2, HOXB13 mutations with PSA >3.0 ng/mL Prior negative prostate biopsy with subsequent sustained PSA elevation or new suspicious mpMRI lesions Unexplained bone pain or pathological fracture with elevated PSA requiring exclusion of primary prostate malignancy Aggravated bladder outlet obstruction with elevated PSA or abnormal DRE requiring differentiation of malignant obstruction
Key exclusion criteria (1 listed)
- Confirmed prostate cancer receiving radical surgery, radiotherapy, androgen deprivation therapy or active surveillance Acute bacterial prostatitis, febrile urinary tract infection or acute urinary retention within the preceding 4 weeks Prostate massage, cystoscopy, ejaculation within 72 hours; prostate biopsy within 6 weeks; transurethral prostate surgery within 3 months prior to screening Active concurrent malignancy or history of any malignant tumor within the past 5 years (non-melanoma skin cancer excluded) Severe Child-Pugh grade C liver dysfunction, eGFR <30 mL/min/1.73m², coagulopathy (INR >1.5 or platelet count <50×10⁹/L) Unable to discontinue anticoagulants (warfarin, dabigatran, rivaroxaban) or dual antiplatelet therapy for ≥5 days Severe cognitive impairment or acute psychiatric disorder precluding independent informed consent, follow-up and biospecimen collection Participation in other interventional clinical trials within 3 months or concurrent observational trials interfering with study outcomes Hematological disorders including myelodysplastic syndrome and leukemia that alter serum nucleic acid stability Severe peripheral vascular disease hindering venipuncture or inability to comply with fasting blood collection requirements
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 |
|---|---|---|
| Serum microRNA panel detection for prostate lesion differentiationThis diagnostic test quantitatively detects a custom panel of circulating microRNAs (miRNAs) extracted from fasting serum specimens collected from participants within 24 hours prior to transrectal ultrasound-guided prostate biopsy. Total RNA is isolated from serum samples, reverse-transcribed into cDNA, and quantified via quantitative real-time PCR (qRT-PCR). The miRNA expression signature is used to construct a logistic regression/machine learning diagnostic model, whose discriminatory performance is benchmarked against total PSA, f/t PSA ratio, and multiparametric MRI (mpMRI). Unique aspects of this test include: 1) systematic evaluation of miRNA stability under varied serum storage temperatures and storage durations; 2) assessment of inter-operator, inter-batch reagent, and inter-platform assay reproducibility via coefficient of variation (CV); 3) stratified performance testing across PSA gray zone (4-10 ng/mL), ISUP low/high-risk prostate cancer subgrou | Diagnostic test | BPH cohort, PCa cohort |
Primary outcome
Area under the receiver operating characteristic curve (AUC) of serum miRNA panel for differentiating prostate cancer from benign prostatic hyperplasia
Time frame: Completed after pathological diagnosis results of prostate biopsy are available for all enrolled participants, following serum miRNA laboratory testing and statistical analysis of the full study cohort.
Evaluate the AUC, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the serum miRNA signature using transrectal ultrasound-guided prostate biopsy pathology as the diagnostic gold standard. Compare the miRNA panel's diagnostic performance against serum total PSA via DeLong test.
2 secondary outcomes
Incremental diagnostic benefit of serum miRNA panel combined with PSA or mpMRI; stratified diagnostic performance across PSA subgroups and prostate cancer risk tiers
Time frame: After completion of all biopsy pathology reports, serum miRNA testing and stratified subgroup statistical analyses of the full 500-subject cohort
Assay reproducibility and serum miRNA stability under different sample storage conditions
Time frame: Concurrent with batch serum miRNA laboratory testing throughout participant enrollment and sample processing phase
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 11 Aug 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing is undecided at present. All participant serum samples, raw miRNA detection data, clinical examination records and pathology reports contain sensitive personal clinical information and biospecimen-related private data protected by hospital biobank management regulations and Chinese personal information protection laws. The research team needs to complete data de-identification, formulate standardized data access agreements and obtain additional ethics committee approval before formalizing any data sharing scheme. No definitive IPD sharing policy has been finalized prior to completion of study enrollment, laboratory testing and statistical analysis.
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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.
Wei Xue, PhD principal investigator
RenJi Hospital
Pengfei Wang, MD principal investigator
RenJi Hospital
Liang Dong, PhD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Diagnosis), run by RenJi Hospital at 1 site 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 1 inclusion and 1 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Wei Xue, PhD (8621-58752345, uroxuewei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating characteristic curve (AUC) of serum miRNA panel for differentiating prostate cancer from benign prostatic hyperplasia (time frame: Completed after pathological diagnosis results of prostate biopsy are available for all enrolled participants, following serum miRNA laboratory testing and statistical analysis of the full study cohort.). 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 11 Aug 2026.