An observational study in Prostate Cancer (Diagnosis), sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by RenJi Hospital · Observational
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 500 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 with subsequent sustained PSA elevation or new suspicious mpMRI lesions Unexplained bone pain or pathological fracture with elevated PSA requiring exclusion of primary prostate 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 within 6 weeks; transurethral prostate surgery within 3 months prior to screening Active concurrent or history of any malignant tumor within the past 5 years (non-melanoma skin cancer excluded) Severe grade C liver dysfunction, \<30 mL/min/1.73m², coagulopathy ( >1.5 or 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 , 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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.
Incremental diagnostic benefit of serum miRNA panel combined with PSA or mpMRI; stratified diagnostic performance across PSA subgroups and prostate cancer risk tiers
1\. 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.
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
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.
Time frame: Concurrent with batch serum miRNA laboratory testing throughout participant enrollment and sample processing phase
Plan to share: 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.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Oct 2027, 17 months after the start.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 17 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
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