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De klinische studie NCT07398690 (INSIGHT-PCa) voor Prostaatkanker (diagnose), prostaatkanker is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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INSIGHT-PCa: MRI- and PHI-Guided Risk-Adapted Strategy for Prostate Cancer Diagnosis 1.432 Gerandomiseerd

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De klinische studie NCT07398690 (INSIGHT-PCa) is een interventioneel studie bij Prostaatkanker (diagnose), prostaatkanker met de status rekruterend. Het doel is om 1.432 deelnemers te includeren vanaf 9 maart 2026. De studie wordt geleid door In Gab Jeong, MD en de voltooiing is gepland op 31 december 2029. Laatste update op ClinicalTrials.gov: 17 maart 2026.
Beknopte samenvatting
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...

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Uitgebreide beschrijving
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...

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Officiële titel

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)

Aandoeningen
Prostaatkanker (diagnose)prostaatkanker
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • INSIGHT-PCa
  • AMCURO- 2026-1
NCT-ID
NCT07398690
Startdatum (Werkelijk)
2026-03-09
Laatste update geplaatst
2026-03-17
Verwachte einddatum
2029-12-31
Inschrijving (Geschat)
1.432
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Trefwoorden
Prostate cancer
Multiparametric MRI
Prostate Health Index
Risk-adapted diagnosis
MRI-targeted biopsy
Biopsy reduction
Primaire doel
Diagnostisch
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
Actieve comparatorStandard MRI-Based Diagnostic Strategy (Control)
Conventional Standard Diagnostic Procedure
Diagnostische procedure
PI-RADS 1-2: Systematic 12-core TRUS-guided biopsy PI-RADS 3-5: Combined MRI-targeted biopsy and systematic 12-core biopsy
ExperimenteelINSIGHT-PCa Risk-Adapted Diagnostic Strategy (Experimental)
Experimental Diagnostic Procedure
Diagnostische 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
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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)
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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)
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
20 Years
Geslachten die in aanmerking komen voor de studie
Man
  • 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)
Verantwoordelijke instantie
In Gab Jeong, MD, Sponsor-Onderzoeker, Professor, Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Centraal Contactpersoon
Contact: In Gab Jeong, M.D. Ph.D, 82-2-3010-5892, [email protected]
1 Studielocaties in 1 landen
Asan Medical Center, Seoul, South Korea
In Gab Jeong, MD, PhD, Contact, 82-2-3010-5892, [email protected]
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