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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,432
- 试验地点
- 1
- 主要终点
- Detection of clinically significant prostate cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard MRI-Based Diagnostic Strategy (Control)
Conventional Standard Diagnostic Procedure
干预措施: Diagnostic Procedure (Diagnostic Test)
INSIGHT-PCa Risk-Adapted Diagnostic Strategy (Experimental)
Experimental Diagnostic Procedure
干预措施: Diagnostic Procedure (Diagnostic Test)
结局指标
主要结局
Detection of clinically significant prostate cancer
时间窗: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Proportion of participants diagnosed with clinically significant prostate cancer (Gleason score ≥3+4)
次要结局
- 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))
研究者
In Gab Jeong, MD
Professor, Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Asan Medical Center