Using MRI and a blood test to decide who needs a prostate biopsy
Tests whether MRI plus the Prostate Health Index can spare some men biopsies.
Plain-language title generated from the registry record
Registry title: INSIGHT-PCa: MRI- and PHI-Guided Risk-Adapted Strategy for Prostate Cancer Diagnosis
Key facts
- Where
- Seoul, South KoreaSee the site
Where in South Korea
- Asan Medical CenterSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- In Gab Jeong, MD
- Trial code
- NCT07398690
- Record updated
- 17 March 2026
- Original description
Prostate cancer diagnosis based on systematic or MRI-targeted biopsy is associated with substantial overdiagnosis and unnecessary invasive procedures. Although multiparametric MRI improves detection of clinically significant prostate cancer, optimal criteria for biopsy omission-particularly in men with equivocal MRI findings-remain uncertain.Read full original descriptionShow less
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)
Prostate cancer diagnosis based on systematic or MRI-targeted biopsy is associated with substantial overdiagnosis and unnecessary invasive procedures. Although multiparametric MRI improves detection of clinically significant prostate cancer, optimal criteria for biopsy omission-particularly in men with equivocal MRI findings-remain uncertain.
The INSIGHT-PCa study is a prospective, multicenter, randomized controlled trial designed to evaluate whether a risk-adapted diagnostic strategy integrating multiparametric MRI and the Prostate Health Index (PHI) can reduce unnecessary prostate biopsies without compromising detection of clinically significant prostate cancer.
Participants with suspected prostate cancer will be randomized to either a standard MRI-based diagnostic pathway or an optimized strategy in which biopsy decisions are guided by combined MRI findings and PHI density. The primary objective is to demonstrate non-inferiority in the detection of clinically significant prostate cancer while reducing biopsy utilization and biopsy-related adverse events.
Inclusion: 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: 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.