Health TrialsbyHealthPanel

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

ConditionsProstate Cancer (Diagnosis)Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20+
SponsorIn Gab Jeong, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diagnostic Procedure

    Diagnostic 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

  • Diagnostic Procedure

    Diagnostic test

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

Treatment groups

1,432 Participants
are divided into 2 treatment groups
Group A: Standard MRI-Based Diagnostic Strategy (Control)Active comparator 1 intervention
Group B: INSIGHT-PCa Risk-Adapted Diagnostic Strategy (Experimental)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Detection of clinically significant prostate cancer

Proportion of participants diagnosed with clinically significant prostate cancer (Gleason score ≥3+4)

Time frame
From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)

Secondary outcomes

1

Detection of clinically insignificant prostate cancer (Gleason score 6)

Time frame
From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
2

Proportion of participants in whom prostate biopsy is omitted

Time frame
From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
3

Total number of biopsy cores obtained

Time frame
From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
4

Biopsy-related adverse events (pain, infection, bleeding)

Time frame
Within 30 days after prostate biopsy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

In Gab Jeong, MD

Lead sponsor

Asan Medical Center

Sponsor institution

Ministry of Health and Welfare (Republic of Korea)

Collaborator

Source ClinicalTrials.gov
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