MRI- and PHI-guided approach to decide when a prostate biopsy is needed
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)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1432 (estimated) |
| Ages | 20 Years and up |
| Sex | Male |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07398690 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.