Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection: A Synergy of Novel Biomarkers, Advanced Imaging, and Robotic-assisted Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Diagnosis of clinically significant Prostate cancer (csPCa); • csPCa is diagnosis of ISUP Grade group ≥2 prostate cancer in at least 1 biopsy core
研究概览
简要总结
This is a prospective clinical study recruiting 510 men at risk of PCa to undergo urine, blood, AI-assisted ultrasound and AI-assisted MRI investigations to stratify risk of clinically significant PCa (csPCa). (sample size calculation in section 5)
详细描述
All recruited patients will undergo investigations including urine for spermine, blood for miRNA, TRUS, and MRI prostate. Patients with high suspicion of csPCa in any one step (urine, blood, ultrasound, OR MRI) will be offered an image-guided prostate biopsy. This will be followed by machine learning techniques to find the best combination in predicting csPCa.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men ≥18 years of age
- •Clinical suspicion of prostate cancer
- •Serum Prostate-specific antigen (PSA) 4-20 ng/mL
- •Digital rectal examination ≤ cT2 (organ confined cancer)
- •Able to provide written informed consent
排除标准
- •Prior prostate biopsy
- •Past or current history of prostate cancer
- •Contraindicated to undergo plain MRI scan (e.g. pacemaker in-situ, claustrophobia)
- •Contraindicated to transperineal prostate biopsy: active urinary tract infection, fail TRUS probe insertion or lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped
结局指标
主要结局
Diagnosis of clinically significant Prostate cancer (csPCa); • csPCa is diagnosis of ISUP Grade group ≥2 prostate cancer in at least 1 biopsy core
时间窗: Through study completion, an average of 1 year
Assessed by by machine learning algorithms utilizing clinical parameters, novel biomarkers and AI-assisted imaging
次要结局
- Diagnosis of any grade of prostate cancer(Through study completion, an average of 1 year)
- Proportion of men with diagnosis of clinically insignificant prostate cancer(Through study completion, an average of 1 year)
- Prostate biopsies that can be avoided(Through study completion, an average of 1 year)
- The concordance of AI-assisted TRUS & MRI diagnosis and biopsy outcomes(Through study completion, an average of 1 year)
研究者
CHIU Ka Fung Peter
Associate Professor
Chinese University of Hong Kong