MRI-Assisted Guidance for Non-Essential Tissue Sampling
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45+
SponsorShanghai East Hospital
About this trial
The study aims to determine if a less painful and less invasive prostate biopsy approach is safe for certain men with a high risk of prostate cancer.
Currently, when a man has a suspicious MRI scan, standard medical guidelines recommend a "combined biopsy." This means the urologist performs a Targeted Biopsy (taking 3-5 tissue samples directly from the suspicious area seen on the MRI) followed immediately by a Systematic Biopsy (taking 12 additional samples blindly from the rest of the prostate). While this combined approach maximizes cancer detection, the 12 extra needles from the systematic biopsy increase the risk of bleeding, pain, and urinary infection.
Researchers believe that for men who already have a very high prostate-specific antigen (PSA) level and a highly suspicious MRI, the targeted biopsy alone might be enough to detect any dangerous cancer. In these high-risk men, the extra 12 systematic needles might offer little to no additional benefit ("diminishing returns").
In this study, 850 men will undergo the standard combined biopsy procedure. However, to test the researchers' theory with extreme precision, the tissue samples from the Targeted Biopsy and the Systematic Biopsy will be placed into completely separate, uniquely barcoded jars (the "One Core, One Jar" spatial mapping protocol). The pathologist will examine each tissue sample independently, without knowing which method was used to collect it.
By comparing the results within each patient, the study will determine exactly how many dangerous cancers were found exclusively by the systematic biopsy. If this number is clinically negligible (less than 5%) in men with high PSA levels, it will prove that the 12 extra needles are unnecessary for this specific group.
The ultimate goal of the trial is to safely "de-escalate" prostate cancer diagnostics-sparing high-risk men from the physical trauma, complications, and costs of unnecessary systematic sampling, while ensuring no dangerous cancers are missed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Paired Prostate Biopsy Cohort (TB + SB)
Procedure/SurgeryAll enrolled participants (PSA ≥ 4.0 ng/mL and PI-RADS 4-5 lesions) will undergo a standardized paired biopsy procedure during a single clinical session. Step 1: MRI-Targeted Biopsy (TB) of the index lesion(s). Step 2: A standard 12-core Systematic Biopsy (SB) covering the peripheral and transition zones. To allow for independent and unbiased pathological evaluation, biopsy cores will be strictly handled using a high-fidelity "One Core, One Jar" spatial mapping protocol. The diagnostic utility (incremental detection rate) of the systematic biopsy will be compared within-patient and further analyzed across two pre-specified risk strata (PSA 4-20 ng/mL vs. PSA \> 20 ng/mL).
Treatment groups
1,235 Participants
are divided into 1 treatment groupGroup A: Paired Prostate Biopsy Cohort (TB + SB)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The primary endpoint is the Incremental Detection Rate (IDR) of clinically significant prostate cancer provided by systematic biopsy
1. Absolute Marker Framework: Stratified by serum PSA (\> 20 ng/ml vs. 4-20 ng/ml). 2. Relative Marker Framework: Stratified by PSA Density (PSAD), utilizing a pre-specified threshold (e.g., ≥ 0.15 ng/ml² vs. \< 0.15 ng/ml²). Both frameworks aim to validate a 'stopping rule' for systematic biopsy."
Time frame
within 2 weeks after biopsySecondary outcomes
1
Rate of Treatment Management Change
The proportion of patients in whom the addition of Systematic Biopsy findings alters the recommended treatment plan compared to the plan based on Targeted Biopsy findings alone
Time frame
within 2 weeks after biopsy2
Pathological Upgrading Rate
The proportion of patients in whom Systematic Biopsy detects a higher ISUP Grade Group than that detected by Targeted Biopsy.
Time frame
Within 2 weeks after biopsy3
Diagnostic Accuracy Metrics
Sensitivity, Specificity, NPV, and PPV of the "Target-Only" strategy, using the "Combined Biopsy" result as the composite reference standard.
Time frame
within 2 weeks after biopsy4
Virtual Safety Analysis
A modelled analysis estimating the reduction in adverse events (e.g., haematuria, retention) if Systematic Biopsy had been omitted in the Experimental Stratum. This is calculated based on the "Number of Cores Saved" multiplied by per-core complication risk coefficients derived from trial safety data.
Time frame
within 2 weeks after biopsySponsors and contacts
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Source ClinicalTrials.gov