Trial Radar AI
Clinical Trial NCT07398690 (INSIGHT-PCa) for Prostate Cancer (Diagnosis), Prostate Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

INSIGHT-PCa: MRI- and PHI-Guided Risk-Adapted Strategy for Prostate Cancer Diagnosis 1,432 Randomized

Recruiting
Clinical Trial NCT07398690 (INSIGHT-PCa) is an interventional study for Prostate Cancer (Diagnosis), Prostate Cancer that is recruiting. It started on 9 March 2026 with plans to enroll 1,432 participants. Led by In Gab Jeong, MD, it is expected to complete by 31 December 2029. The latest data from ClinicalTrials.gov was last updated on 17 March 2026.
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...

Show More
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 gr...

Show More
Official Title

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)

Conditions
Prostate Cancer (Diagnosis)Prostate Cancer
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • INSIGHT-PCa
  • AMCURO- 2026-1
NCT ID Number
NCT07398690
Start Date (Actual)
2026-03-09
Last Update Posted
2026-03-17
Completion Date (Estimated)
2029-12-31
Enrollment (Estimated)
1,432
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Prostate cancer
Multiparametric MRI
Prostate Health Index
Risk-adapted diagnosis
MRI-targeted biopsy
Biopsy reduction
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorStandard MRI-Based Diagnostic Strategy (Control)
Conventional Standard Diagnostic Procedure
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
ExperimentalINSIGHT-PCa Risk-Adapted Diagnostic Strategy (Experimental)
Experimental Diagnostic Procedure
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime 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)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
20 Years
Eligible Sexes
Male
  • 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

  • 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
In Gab Jeong, MD logoIn Gab Jeong, MD
Ministry of Health and Welfare (Republic of Korea) logoMinistry of Health and Welfare (Republic of Korea)
Study Responsible Party
In Gab Jeong, MD, Sponsor-Investigator, Professor, Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Study Central Contact
Contact: In Gab Jeong, M.D. Ph.D, 82-2-3010-5892, [email protected]
1 Study Locations in 1 Countries
Asan Medical Center, Seoul, South Korea
In Gab Jeong, MD, PhD, Contact, 82-2-3010-5892, [email protected]
Recruiting