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NCT Number: NCT07516223

MRI-Assisted Guidance for Non-Essential Tissue Sampling

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.

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Key information

Conditions

PSA Progression PsA

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai east hospital

Shanghai, China

Location status: Recruiting

Location contact

Shanghai East hospital ethics committee

CONTACT

[email protected]

86-021-38804518

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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).

Primary outcomes

  1. The primary endpoint is the Incremental Detection Rate (IDR) of clinically significant prostate cancer provided by systematic biopsy

    Time frame: within 2 weeks after biopsy

    • Absolute Marker Framework: Stratified by serum PSA (> 20 ng/ml vs. 4-20 ng/ml).
    • 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."

Secondary outcomes

  1. Rate of Treatment Management Change

    Time frame: within 2 weeks after biopsy

    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

  2. Pathological Upgrading Rate

    Time frame: Within 2 weeks after biopsy

    The proportion of patients in whom Systematic Biopsy detects a higher ISUP Grade Group than that detected by Targeted Biopsy.

  3. Diagnostic Accuracy Metrics

    Time frame: within 2 weeks after biopsy

    Sensitivity, Specificity, NPV, and PPV of the "Target-Only" strategy, using the "Combined Biopsy" result as the composite reference standard.

  4. Virtual Safety Analysis

    Time frame: within 2 weeks after biopsy

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shanghai East hospital ethics committee

CONTACT

[email protected]

86-021-38804518

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Registry information

Official study title

MRI-Assisted Guidance for Non-Essential Tissue Sampling (MAGNET): an Investigator-initiated, International, Multicentre, Prospective, Pairedcohort, Diagnostic Utility Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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