Evaluation of Suspicious Prostate Lesions Via Sequential Bi-parametric MRI: A Multi-center Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- csPCa detection rate
研究概览
简要总结
This study aims to establish a prospective exploratory cohort and database to observe the dynamic evolution of bi-parametric MRI (bpMRI). Investigators intend to study the clinical utility of sequential MRI combined with prostate biopsy in the diagnosis of prostate cancer. Specifically, by utilizing bpMRI findings and their dynamic changes to guide the timing of biopsies, investigators aim to avoid unnecessary procedures. Furthermore, the safety and efficacy of this strategy will be assessed through long-term follow-up, ultimately promoting the precision diagnosis and treatment of prostate cancer.
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 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 85 years.
- •Total PSA (tPSA) level ranging from 3 ng/ml to 20 ng/ml (inclusive).
- •Underwent prostate MRI at the study institution with complete imaging sequences.
- •Capable of providing written informed consent.
- •Patients with PI-RADS 4-5, or PI-RADS 3 combined with PSAD ≥ 0.2 ng/ml², who have undergone prostate biopsy with no diagnosis of clinically significant prostate cancer (csPCa).
- •Biopsy-naïve patients with PI-RADS 2, or PI-RADS 3 combined with PSAD < 0.2 ng/ml².
排除标准
- •Pathologically confirmed diagnosis of clinically significant prostate cancer (csPCa).
- •Contraindications to prostate biopsy or inability to tolerate the procedure.
- •Current use of 5-alpha reductase inhibitors (5-ARIs).
- •History of hip replacement, metallic hip arthroplasty, or extensive pelvic orthopedic surgery with metallic hardware, or presence of other implants that would degrade MRI image quality.
- •Contraindications to bi-parametric MRI (bpMRI) (e.g., severe claustrophobia, cardiac pacemakers).
研究组 & 干预措施
MRI follow-up cohort of patients with clinically suspected prostate cancer
Scheduled Follow-up: All enrolled patients will undergo a follow-up period of 24 months. Every 6 months: PSA testing, Digital Rectal Examination (DRE), and clinical assessment. At months 12 and 24: Repeat bi-parametric MRI (bpMRI) examinations.
Biopsy Decision-Making:
Triggered Biopsy: During the follow-up period (e.g., at month 12), a prostate biopsy will be recommended if the patient exhibits MRI progression to PI-RADS 4/5, or presents with PI-RADS 3 combined with a PSA density (PSAD) > 0.2 ng/ml².
Endpoint Biopsy: To ensure study rigor and safety, patients who have not undergone biopsy due to radiological progression during the 24-month follow-up will be advised to undergo a confirmatory biopsy at the study endpoint (month 24). This aims to maximally exclude the missed diagnosis of clinically significant prostate cancer (csPCa).
干预措施: PSA test (Diagnostic Test)
MRI follow-up cohort of patients with clinically suspected prostate cancer
Scheduled Follow-up: All enrolled patients will undergo a follow-up period of 24 months. Every 6 months: PSA testing, Digital Rectal Examination (DRE), and clinical assessment. At months 12 and 24: Repeat bi-parametric MRI (bpMRI) examinations.
Biopsy Decision-Making:
Triggered Biopsy: During the follow-up period (e.g., at month 12), a prostate biopsy will be recommended if the patient exhibits MRI progression to PI-RADS 4/5, or presents with PI-RADS 3 combined with a PSA density (PSAD) > 0.2 ng/ml².
Endpoint Biopsy: To ensure study rigor and safety, patients who have not undergone biopsy due to radiological progression during the 24-month follow-up will be advised to undergo a confirmatory biopsy at the study endpoint (month 24). This aims to maximally exclude the missed diagnosis of clinically significant prostate cancer (csPCa).
干预措施: Bi parametric MRI (Diagnostic Test)
结局指标
主要结局
csPCa detection rate
时间窗: From enrollment to the end of follow up at 24 weeks
Clinically significant prostate cancer detection rates across different radiological changes (progression, stability, and regression)
次要结局
未报告次要终点