MRI-Assisted Guidance for Non-Essential Tissue Sampling

NCT07516223 | Recruiting DMC

• 1 other identifier: 2026044
• Study Type: interventional
• Target: 1,235
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PSA Progression; PSA

Keywords

prostate biopsy; targeted biopsy; systematic biopsy; MRI

Outcome Measures

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."

  within 2 weeks after biopsy

Secondary Outcomes (4)

• Rate of Treatment Management Change

  within 2 weeks after biopsy

• Pathological Upgrading Rate

  Within 2 weeks after biopsy

• Diagnostic Accuracy Metrics

  within 2 weeks after biopsy

• Virtual Safety Analysis

  within 2 weeks after biopsy

Study Arms (1)

Paired Prostate Biopsy Cohort (TB + SB)

EXPERIMENTAL

Procedure: Paired Prostate Biopsy Cohort (TB + SB)

Interventions

Paired Prostate Biopsy Cohort (TB + SB) PROCEDURE

All 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).

Paired Prostate Biopsy Cohort (TB + SB)

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 45 years. Serum PSA level ≥ 4.0 ng/ml. High-risk MRI findings: Presence of at least one lesion with a PI-RADS score of 4 (Likely) or 5 (Highly Likely) according to v2.1 guidelines11.
• Fitness for transperineal prostate biopsy under local or general anaesthesia. Competency to provide informed consent.

You may not qualify if:

• History of prior prostate biopsy (to ensure baseline risk homogeneity). Prior treatment for prostate cancer or use of 5-alpha reductase inhibitors (5-ARIs) within 6 months.
• Candidates who have explicitly opted for focal therapy prior to biopsy (where systematic mapping remains mandatory).
• Contraindications to MRI (e.g., incompatible implants, severe renal impairment).
• Active urinary tract infection or acute prostatitis.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai east hospital

Shanghai, China

RECRUITING

Central Study Contacts

Shanghai East hospital ethics committee

CONTACT

86-021-38804518; siwei_bao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): April 5, 2028
• Study Completion (Estimated): May 5, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-03

Locations

CN (1)