NCT07398690

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,432

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Dec 2029

First Submitted

Initial submission to the registry

January 27, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

March 17, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

January 27, 2026

Last Update Submit

March 14, 2026

Conditions

Prostate Cancer (Diagnosis)Prostate Cancer

Keywords

Prostate cancerMultiparametric MRIProstate Health IndexRisk-adapted diagnosisMRI-targeted biopsyBiopsy reduction

Outcome Measures

Primary Outcomes (1)

  • Detection of clinically significant prostate cancer

    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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Standard MRI-Based Diagnostic Strategy (Control)

ACTIVE COMPARATOR

Conventional Standard Diagnostic Procedure

Diagnostic Test: Diagnostic Procedure

INSIGHT-PCa Risk-Adapted Diagnostic Strategy (Experimental)

EXPERIMENTAL

Experimental Diagnostic Procedure

Diagnostic Test: Diagnostic Procedure

Interventions

Diagnostic ProcedureDIAGNOSTIC_TEST

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

INSIGHT-PCa Risk-Adapted Diagnostic Strategy (Experimental)

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (5)

  • Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.

    PMID: 25626035RESULT

  • Hugosson J, Mansson M, Wallstrom J, Axcrona U, Carlsson SV, Egevad L, Geterud K, Khatami A, Kohestani K, Pihl CG, Socratous A, Stranne J, Godtman RA, Hellstrom M; GOTEBORG-2 Trial Investigators. Prostate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only. N Engl J Med. 2022 Dec 8;387(23):2126-2137. doi: 10.1056/NEJMoa2209454.

    PMID: 36477032RESULT

  • Hugosson J, Godtman RA, Wallstrom J, Axcrona U, Bergh A, Egevad L, Geterud K, Khatami A, Socratous A, Spyratou V, Svensson L, Stranne J, Mansson M, Hellstrom M. Results after Four Years of Screening for Prostate Cancer with PSA and MRI. N Engl J Med. 2024 Sep 26;391(12):1083-1095. doi: 10.1056/NEJMoa2406050.

    PMID: 39321360RESULT

  • Eklund M, Jaderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, Glaessgen A, Carlsson S, Gronberg H, Nordstrom T; STHLM3 consortium. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920. doi: 10.1056/NEJMoa2100852. Epub 2021 Jul 9.

    PMID: 34237810RESULT

  • Ahdoot M, Wilbur AR, Reese SE, Lebastchi AH, Mehralivand S, Gomella PT, Bloom J, Gurram S, Siddiqui M, Pinsky P, Parnes H, Linehan WM, Merino M, Choyke PL, Shih JH, Turkbey B, Wood BJ, Pinto PA. MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis. N Engl J Med. 2020 Mar 5;382(10):917-928. doi: 10.1056/NEJMoa1910038.

    PMID: 32130814RESULT

MeSH Terms

Conditions

Prostatic NeoplasmsDisease

Interventions

Diagnostic Techniques and Procedures

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnosis

Central Study Contacts

In Gab Jeong, M.D. Ph.D

CONTACT

82-2-3010-5892igjeong@amc.seoul.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 10, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2029

Last Updated

March 17, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)