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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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
• Диагностический тест 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

Первичные конечные точки

• Detection of clinically significant prostate cancer [Срок оценки: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

South Korea · 1 центр

• Asan Medical Center — Seoul

Публикации

• 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 25626035
• 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 36477032
• 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 39321360
• 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 34237810
• 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 32130814

Идентификаторы

NCT: NCT07398690 · AMCURO- 2026-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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