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MRI-Assisted Guidance for Non-Essential Tissue Sampling

RecruitingNAAges 45 Years - anyMaleShanghai East Hospital
NCT07516223 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Paired Prostate Biopsy Cohort (TB + SB)
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Where

1 site
Shanghai east hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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