MRI- and PHI-guided approach to decide when a prostate biopsy is needed
Official title: Integrated Noninvasive Strategy Guided by Multiparametric MRI and the Prostate Health Index for Risk-Adapted Detection of Clinically Significant Prostate Cancer: A Multicenter Randomized Controlled Trial (INSIGHT-PCa Study)
Run by Asan Medical Center · NCT07398690 · Data updated 2026-11-12
This trial will test whether using multiparametric MRI together with the Prostate Health Index (PHI) can safely reduce unnecessary prostate biopsies in biopsy-naïve men with suspected prostate cancer and PSA 3–20 ng/mL.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | Men only |
| Enrollment | 1432 (estimated) |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2029 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT07398690 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Biopsy-naïve men aged 20 or older with PSA 3.0–20.0 ng/mL and/or abnormal digital rectal exam, clinical stage ≤T2, and ability to give informed consent are the intended participants.
✕Probably not a fit
Men with prior prostate biopsy or treatment, recent use of 5-alpha reductase inhibitors, acute prostatitis or UTI, contraindications to MRI or biopsy, or more advanced disease are not eligible and would not benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
INSIGHT-PCa is a prospective, multicenter, randomized controlled trial enrolling 1,432 biopsy-naïve men with suspected prostate cancer and PSA 3–20 ng/mL across five tertiary centers in Korea. Participants are randomized 1:1 to a standard MRI-based pathway (systematic biopsy for PI-RADS 1–2 and combined MRI-targeted plus systematic biopsy for PI-RADS 3–5) or an experimental risk-adapted strategy that uses PHI density (biopsy only if PHI density ≥0.80 for PI-RADS 1–3; MRI-targeted biopsy alone for PI-RADS 4–5). The primary objective is non-inferiority for detection of clinically significant prostate cancer (Gleason score ≥3+4); secondary endpoints include rates of biopsy omission, detection of clinically insignificant cancer, biopsy-related adverse events, and cumulative detection over 24 months. Imaging, biomarker measurement, and biopsy procedures are standardized across sites to compare the two diagnostic algorithms.
Why it matters
Potential benefit: If successful, the approach could lower the number of unnecessary prostate biopsies and related complications while maintaining detection of clinically significant cancers.
How similar studies have gone: Previous studies show multiparametric MRI and PHI individually improve detection and can reduce unnecessary biopsies, but randomized evidence combining MRI and PHI density to guide biopsy omission—especially for PI-RADS 3 lesions—is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male, aged 20 years or older * Serum PSA ≥3.0 ng/mL and ≤20.0 ng/mL and/or abnormal digital rectal -examination * Biopsy-naïve * Clinical stage ≤T2 disease * Ability to provide written informed consent Exclusion Criteria: * Previous prostate biopsy or prostate cancer treatment * Use of 5-alpha reductase inhibitors within 6 months * Acute prostatitis or urinary tract infection within 3 months * Contraindications to MRI * Contraindications to prostate biopsy
Where it's running
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Asan Medical Center
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: In Gab Jeong, M.D. Ph.D
- Email: igjeong@amc.seoul.kr
- Phone: 82-2-3010-5892
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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.