miRNA Panel for PCa Diagnosis

NCT07755592 | Recruiting

• 1 other identifier: LY2026-105-B
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer (Diagnosis)

Keywords

Prostate cancer; BPH; miRNA; serum biomarker; diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  Concurrent with batch serum miRNA laboratory testing throughout participant enrollment and sample processing phase

Study Arms (2)

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.

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.

Diagnostic Test: Serum microRNA panel detection for prostate lesion differentiation

Interventions

Serum microRNA panel detection for prostate lesion differentiation DIAGNOSTIC_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

BPH cohort; PCa cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only cisgender males aged 18 years or older are eligible for enrollment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, urine, expressed prostatic fluid

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Xue, PhD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Pengfei Wang, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Liang Dong, PhD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xue, PhD

CONTACT

8621-58752345; uroxuewei@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

CN (1)