Prostate Cancer (Diagnosis), Prostate Cancer
Conditions
Keywords
Prostate cancer, Multiparametric MRI, Prostate Health Index, Risk-adapted diagnosis, MRI-targeted biopsy, Biopsy reduction
Brief summary
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.
Detailed description
This multicenter, prospective, randomized controlled trial will enroll 1,432 biopsy-naïve men with suspected prostate cancer across five tertiary referral centers in Korea. Eligible participants will have a serum prostate-specific antigen (PSA) level between 3 and 20 ng/mL. Participants will be randomized in a 1:1 ratio to either a control group receiving a standard MRI-based diagnostic pathway or an experimental group managed using an optimized, risk-adapted strategy integrating multiparametric MRI and the Prostate Health Index. In the control group, men with PI-RADS scores of 1-2 will undergo systematic 12-core transrectal ultrasound-guided biopsy, while those with PI-RADS scores of 3-5 will receive combined MRI-targeted and systematic biopsy. In the experimental group, men with PI-RADS scores of 1-3 will undergo biopsy only if the PHI density is ≥0.80; biopsy will be omitted in those with lower PHI density and replaced by active surveillance. Men with PI-RADS scores of 4-5 will undergo MRI-targeted biopsy alone. The trial is designed as a non-inferiority study. The primary endpoint is the proportion of clinically significant prostate cancer (Gleason score ≥3+4). Secondary endpoints include detection of clinically insignificant cancer, biopsy omission rates, biopsy-related adverse events, and cumulative detection of clinically significant prostate cancer during 24 months of follow-up.
Interventions
DIAGNOSTIC_TESTDiagnostic Procedure
PI-RADS 1-3: PHI density \<0.80 → Biopsy omitted; active surveillance PHI density ≥0.80 → Systematic 12-core TRUS-guided biopsy PI-RADS 4-5: MRI-targeted biopsy alone
Sponsors
In Gab Jeong, MD
Ministry of Health and Welfare (Republic of Korea)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of clinically significant prostate cancer | From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks) | Proportion of participants diagnosed with clinically significant prostate cancer (Gleason score ≥3+4) |
Secondary
| Measure | Time frame |
|---|---|
| Detection of clinically insignificant prostate cancer (Gleason score 6) | From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks) |
| Proportion of participants in whom prostate biopsy is omitted | From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks) |
| Total number of biopsy cores obtained | From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks) |
| Biopsy-related adverse events (pain, infection, bleeding) | Within 30 days after prostate biopsy |
| Cumulative detection of clinically significant prostate cancer over 24 months | Over 24 months of follow-up |
| Gleason grade upgrading in participants undergoing radical prostatectomy | At the time of radical prostatectomy (within 12 months of diagnosis) |
Countries
South Korea
Contacts
CONTACTIn Gab Jeong, M.D. Ph.D
Outcome results
None listed