UPRISE (Urine Prostate Screening Integrated With MRI for Prostate Cancer Early Detection)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Clinically significant prostate cancer (csPCa), defined as Gleason Grade (GG) Group 2-5
研究概览
简要总结
This clinical trial tests how well a urine prostate cancer screening test, My Prostate Score 2 (MPS2), integrated with magnetic resonance imaging (MRI) works for early detection of prostate cancer. MPS2 is an investigational urine-based test designed to help identify the likelihood of having aggressive prostate cancer. MPS2 testing works by measuring specific early detection biomarkers that include genetic information. This next-generation test aims to address a major challenge in prostate cancer care-detecting only the cancers that truly need treatment. Results may lead to paradigm shifts in early detection algorithms and reduce reliance on MRI and biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 50-75
- •PSA 3-20 ng/ml within the previous 3 months
- •Fit to undergo all procedures listed in protocol per treating physician's discretion
- •No prostate biopsy in the past 4 years
- •No prostate MRI in the past 2 years
- •Able to provide written informed consent
排除标准
- •Prior diagnosis of prostate cancer
- •Contraindication to MRI (e.g. claustrophobia, pacemaker)
- •Contraindication to prostate biopsy
- •Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
研究组 & 干预措施
Arm I (MPS2)
Patients undergo urine sample collection for MPS2 testing. Patients' treating physicians review and utilize the results of the MPS2 test to determine if patients undergo SOC MRI and/or biopsy.
干预措施: Biopsy Procedure (Procedure)
Arm I (MPS2)
Patients undergo urine sample collection for MPS2 testing. Patients' treating physicians review and utilize the results of the MPS2 test to determine if patients undergo SOC MRI and/or biopsy.
干预措施: Diagnostic Procedure (Device)
Arm II (MPS2)
Patients undergo urine sample collection for MPS2 testing. Patients' treating physicians do NOT review or utilize results of the MPS2 test to determine if patients undergo a biopsy after SOC MRI.
干预措施: Biopsy Procedure (Procedure)
Arm II (MPS2)
Patients undergo urine sample collection for MPS2 testing. Patients' treating physicians do NOT review or utilize results of the MPS2 test to determine if patients undergo a biopsy after SOC MRI.
干预措施: Diagnostic Procedure (Device)
Arm II (MPS2)
Patients undergo urine sample collection for MPS2 testing. Patients' treating physicians do NOT review or utilize results of the MPS2 test to determine if patients undergo a biopsy after SOC MRI.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm I (MPS2)
Patients undergo urine sample collection for MPS2 testing. Patients' treating physicians review and utilize the results of the MPS2 test to determine if patients undergo SOC MRI and/or biopsy.
干预措施: Electronic Health Record Review (Other)
Arm I (MPS2)
Patients undergo urine sample collection for MPS2 testing. Patients' treating physicians review and utilize the results of the MPS2 test to determine if patients undergo SOC MRI and/or biopsy.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm II (MPS2)
Patients undergo urine sample collection for MPS2 testing. Patients' treating physicians do NOT review or utilize results of the MPS2 test to determine if patients undergo a biopsy after SOC MRI.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Clinically significant prostate cancer (csPCa), defined as Gleason Grade (GG) Group 2-5
时间窗: Up to 120 days
Will compare the proportions of patients with detected csPCa in the intervention and control arms (p1 and p2, respectively) using the OBrien Fleming stopping boundaries which control the overall one-sided Type I error rate to be less than .10.
次要结局
- Number of biopsies performed(Up to 120 days)
- Detection of GG1 cancers(Up to 120 days)
- Number of multiparametric magnetic resonance imaging performed(Up to 120 days)
- Adherence to the management recommendations in the biomarker-based arm(Up to 120 days)
- My Prostate Score 2 (MPS2) performance for detecting csPCa(Up to 120 days)
- Cost(Up to 120 days)