INSIGHT-PCa: MRI- and PHI-Guided Risk-Adapted Strategy for Prostate Cancer Diagnosis (INSIGHT-PCa)

March 14, 2026 updated by: In Gab Jeong, MD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1432

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard MRI-Based Diagnostic Strategy (Control)
Conventional Standard Diagnostic Procedure
Diagnostic test: Diagnostic 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

Diagnostic test: Diagnostic Procedure
PI-RADS 1-2: Systematic 12-core TRUS-guided biopsy PI-RADS 3-5: Combined MRI-targeted biopsy and systematic 12-core biopsy
Experimental: INSIGHT-PCa Risk-Adapted Diagnostic Strategy (Experimental)
Experimental Diagnostic Procedure
Diagnostic test: Diagnostic 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

Diagnostic test: Diagnostic Procedure
PI-RADS 1-2: Systematic 12-core TRUS-guided biopsy PI-RADS 3-5: Combined MRI-targeted biopsy and systematic 12-core biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of clinically significant prostate cancer
Time Frame: 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)
From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection of clinically insignificant prostate cancer (Gleason score 6)
Time Frame: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Proportion of participants in whom prostate biopsy is omitted
Time Frame: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Total number of biopsy cores obtained
Time Frame: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Biopsy-related adverse events (pain, infection, bleeding)
Time Frame: Within 30 days after prostate biopsy
Within 30 days after prostate biopsy
Cumulative detection of clinically significant prostate cancer over 24 months
Time Frame: Over 24 months of follow-up
Over 24 months of follow-up
Gleason grade upgrading in participants undergoing radical prostatectomy
Time Frame: At the time of radical prostatectomy (within 12 months of diagnosis)
At the time of radical prostatectomy (within 12 months of diagnosis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

In Gab Jeong, MD

Collaborators

Ministry of Health and Welfare (Republic of Korea)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCURO- 2026-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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