miRNA panel test to help diagnose prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center prospective diagnostic accuracy study at Renji Hospital in Shanghai. It plans to enroll 500 men aged 18 or older who meet criteria suggesting possible prostate cancer and are indicated for biopsy. Participants will provide serum samples to test a novel microRNA panel that aims to differentiate prostate lesions causing suspected cancer. The study will evaluate how well the blood test can distinguish malignant from non-malignant prostate conditions compared with current diagnostic standards. Enrollment occurs between May 2026 and May 2027, with exclusions including prior treated prostate cancer, recent procedures, active other cancers, severe organ failure, coagulation disorders, or inability to consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• Renji Hospital Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Wei Xue, PhD — RenJi Hospital
• Study coordinator: Wei Xue, PhD
• Email: uroxuewei@163.com
• Phone: 8621-58752345

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.