MRI-guided prostate biopsy using targeted sampling only for high-risk men
Official title: MRI-Assisted Guidance for Non-Essential Tissue Sampling (MAGNET): an Investigator-initiated, International, Multicentre, Prospective, Pairedcohort, Diagnostic Utility Study
Run by Shanghai East Hospital · NCT07516223 · Data updated 2026-11-12
This study tests whether a targeted MRI-guided prostate biopsy alone can safely replace the standard combined biopsy in men with very high PSA and suspicious MRI.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years and up |
| Sex | Men only |
| Enrollment | 1235 (estimated) |
| Sponsor | Shanghai East Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | April 5, 2026 |
| Main results expected | April 5, 2028 |
| Study ends | May 5, 2028 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07516223 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 45 years or older with PSA ≥ 4.0 ng/mL and PI-RADS 4 or 5 MRI findings who are fit for transperineal biopsy.
✕Probably not a fit
Patients with lower-risk MRI, prior prostate cancer treatment, recent 5-alpha reductase inhibitor use, or contraindications to MRI/biopsy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In men with a highly suspicious MRI (PI-RADS 4 or 5) and elevated PSA, researchers will compare targeted biopsy alone to the usual combined approach that also adds systematic sampling. The study uses MRI guidance to target biopsies to suspicious areas while avoiding routine systematic sampling. Participants undergo a prostate biopsy under local or general anesthesia, and prior biopsy history and certain treatments exclude enrollment. The aim is to see if fewer needle passes can maintain cancer detection while reducing pain and complications. The trial is conducted at Shanghai East Hospital and is labeled as an interventional paired cohort study.
Why it matters
Potential benefit: If successful, patients may experience less pain and fewer biopsy-related complications without sacrificing cancer detection.
How similar studies have gone: Previous work suggests MRI-targeted biopsy can detect clinically significant cancer, but whether targeted-only approaches are non-inferior to combined biopsy is still being evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Shanghai east hospital
Shanghai, China Recruiting
Study contacts
- Study coordinator: Shanghai East hospital ethics committee
- Email: siwei_bao@163.com
- Phone: 86-021-38804518
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.