Establishing the Clinical Utility of ClarityDX Prostate
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,450
- 试验地点
- 7
- 主要终点
- Proportion of patients who receive biopsy and are not diagnosed with clinically significant prostate cancer
研究概览
简要总结
ClarityDX Prostate builds upon the utility of total and free PSA as well as simple clinical features in a decision support model to determine a patient's risk of having clinically significant prostate cancer. The highly accurate ClarityDX Prostate risk score enables clinicians and patients to collectively make more informed decisions regarding the appropriateness of subsequent imaging or biopsy procedures. The clinical pathway aligns with the Canadian Urological Association (CUA) to use adjunctive strategies to better stratify risk of clinically significant prostate cancer.
ClarityDX Prostate consists of four separate models that can be used depending on the information available:
- ClarityDX Prostate. This model incorporates the patient's total PSA and free PSA levels as well as the age of the patient and whether they have had a previous negative biopsy.
- ClarityDX Prostate + DRE. This model incorporates ClarityDX Prostate + DRE (normal or abnormal DRE findings).
- ClarityDX Prostate + MRI. This model incorporates ClarityDX Prostate + MRI (PI-RADS score and prostate volume as determined from an mpMRI scan).
- ClarityDX Prostate + MRI + DRE. This model incorporates ClarityDX Prostate + MRI + DRE.
PRIMARY OBJECTIVE The purpose of this study is to investigate the clinical utility of ClarityDX Prostate in reducing further healthcare utilization for men identified to be at risk of prostate cancer.
SECONDARY OBJECTIVES
- Assess the effect of ClarityDX Prostate on the proportion of negative biopsies and biopsies diagnosing Gleason Grade (GG)<2.
- Measure the difference in MRI numbers between the test and control groups.
- Evaluate the effect of ClarityDX Prostate on the prioritization of healthcare services to participants with high-risk of having clinically significant prostate cancer.
- Infer the potential to use ClarityDX Prostate for prostate cancer screening to inform urology referral.
- Perform a health economics assessment and cost-benefit analysis for the use of ClarityDX Prostate.
DESIGN
- Prospective, randomized, two-armed clinical utility study that will enroll participants referred to urology clinics for suspicion of prostate cancer.
- The study will enroll a total of 1,450 consenting male participants across five urology clinics in Canada. A primary cohort of 1,074 participants will be recruited from two clinics in Alberta. The remaining participants will be competitively recruited from three additional clinics located in Manitoba, Ontario, and British Columbia
- The arms of the study are ClarityDX Prostate (Test) and Standard of Care (SOC-Control).
详细描述
When stratifying patients for prostate cancer, it is ideal to avoid delay in treating high-risk participants that do require a biopsy, while avoiding unnecessary procedures in low-risk patients. The purpose of this study is to investigate in a real-world setting whether the use of ClarityDX Prostate would further reduce potentially unnecessary healthcare utilization of men referred to urology clinics with suspicion of prostate cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males ≥ 18 years of age
- •Referred to urology for suspicion of prostate cancer
- •No prior prostate cancer diagnosis
- •Willing to participate in the study
- •Availability for cancer care in the jurisdiction of recruitment
排除标准
- •Unwilling to participate in the study
- •Unable to consent
研究组 & 干预措施
ClarityDX Prostate
The results from ClarityDX Prostate will be given to the participant's healthcare team before before they see the participant to decide if an MRI/advanced imaging and/or biopsy should be done. The results of ClarityDX Prostate may or may not influence the decision on what other tests and/or procedures the participant will receive.
干预措施: ClarityDX Prostate (Other)
Blinded Control
Control/Standard of Care arm- ClarityDX Prostate will be run for these participants. Participants and healthcare providers will be blinded to the ClarityDX Prostate results for 12 months ± 2 months. Participants care path will be decided based on the current standard of care. The ClarityDX Prostate results will be unblinded to the study teams at the 12 months follow-up visit. The attending urologist may or may not change the decision on the tests or procedures prescribed after receiving the results of the ClarityDX Prostate test.
干预措施: ClarityDX Prostate, blinded (Other)
结局指标
主要结局
Proportion of patients who receive biopsy and are not diagnosed with clinically significant prostate cancer
时间窗: 12 months
'Not diagnosed with clinically significant prostate cancer' refers to biopsies that show no cancer or clinically insignificant cancer
次要结局
- Proportion of patients diagnosed with clinically significant prostate cancer(12 months)
- Proportion of patients who undergo advanced imaging(12 months)
- Proportion of patients who undergo biopsy(12 months)
- Time from first urologist consultation to clinically significant prostate cancer diagnosis(12 months)
- Number of biopsies deferred(12 months)
- Inferred usability of ClarityDX Prostate for prostate cancer screening prior to urology referral(12 months)
- Inferred reduction in referrals to urology by family physicians as a result of a low-Risk Score from ClarityDX Prostate(12 months)
- Comparison of associated healthcare costs with and without the use of ClarityDX Prostate(12 months)