MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Proportion of clinically significant prostate cancer (≥Gleason score 3+4)
研究概览
简要总结
This paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. The investigators hypothesize that additional MRI-targeted biopsy will detect more clinically significant cancers than standard TRUS biopsy.
Main objective: To compare MR-target vs. standard 12-cores TRUS-biopsy for the diagnosis of clinically significant prostate cancer.
详细描述
Before prostate biopsy, all patients be preceded by mpMRI. The mpMRI is read by an experienced radiologist according to the PI-RADS version 2 scoring system. PI-RADS scoring system is used to assign a degree of doubt prostate cancer. Depending on the PI-RADS score, MR targeted biopsy is determined.
- MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.
- Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men undergoing a first-time prostate biopsy to rule out cancer
- •Serum PSA ≥3ng/mL, ≤20ng/mL
- •Age≥50 years, ≤80 years
- •Clinical stage ≤T2c
- •Patients must be able to provide written informed consent.
排除标准
- •Patients has any prior needle biopsy of the prostate
- •Patients has a prior history of prostate cancer
- •Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
- •Patients has a prior history of BPH operation
- •Patient with uncorrectable coagulopathies
- •Unable to tolerate a TRUS guided biopsy.
- •Patients had 5-alpha reductase inhibitor in the past six months.
- •The patient has had a urinary tract infection or acute prostatitis in the last three months.
- •Any contraindication to MRI (severe claustrophobia, pacemaker, MRI-incompatible prosthesis, eGFR ≤50mls/min)
结局指标
主要结局
Proportion of clinically significant prostate cancer (≥Gleason score 3+4)
时间窗: 2 week after the procedure
次要结局
- Inter-observer variability among radiologists(2 week after the procedure)
- Proportion of clinically insignificant prostate cancer (Gleason score 6)(2 week after the procedure)
- Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer(2 week after the procedure)
- Adverse events of post-biopsy (pain, infection, bleeding etc.)(2 week after the procedure)
- Proportion of Gleason grade upgrading in men undergoing radical prostatectomy(2 week after the surgery)
- Proportion of men in whom mpMRI score (PI-RADS) for suspicion of clinically significant cancer was 3, 4 or 5(2 week after the procedure)
- Cancer core length of the most involved biopsy core (maximum cancer core length, mm)(2 week after the procedure)
- Proportion of men who go on to definitive local treatment or systemic treatment(2 week after the procedure)
研究者
In Gab Jeong
Professor, Department of Urology, Asan Medical Center
Asan Medical Center