Clinical Utility of ClarityDX Prostate

Official title

Establishing the Clinical Utility of ClarityDX Prostate

Overview

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: 1. 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. 2. ClarityDX Prostate + DRE. This model incorporates ClarityDX Prostate + DRE (normal or abnormal DRE findings). 3. ClarityDX Prostate + MRI. This model incorporates ClarityDX Prostate + MRI (PI-RADS score and prostate volume as determined from an mpMRI scan). 4. 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).

Detailed description

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.

Interventions

• Other ClarityDX Prostate
  The ClarityDX Prostate report will be shared with the healthcare team of participants randomized into ClarityDX Prostate arm before the healthcare team decides whether to perform an MRI/advanced imaging and/or biopsy.
• Other ClarityDX Prostate, blinded
  ClarityDX Prostate will be run for the control participants. Participants (and healthcare team) in the control arm will be blinded to the ClarityDX Prostate results and will be considered for prostate MRI/advanced imaging and/or biopsy based on standard of care criteria. The result of the ClarityDX Prostate will be unblinded to study teams at the 12 months follow-up visit (± 2 months). The study team will then share the test results with the participant's health care team to assess whether there

Primary outcome measures

• Proportion of patients who receive biopsy and are not diagnosed with clinically significant prostate cancer [Time frame: 12 months]

Secondary outcome measures (8)

• Proportion of patients diagnosed with clinically significant prostate cancer [Time frame: 12 months]
• Proportion of patients who undergo advanced imaging [Time frame: 12 months]
• Proportion of patients who undergo biopsy [Time frame: 12 months]
• Time from first urologist consultation to clinically significant prostate cancer diagnosis [Time frame: 12 months]
• Number of biopsies deferred [Time frame: 12 months]
• Inferred usability of ClarityDX Prostate for prostate cancer screening prior to urology referral [Time frame: 12 months]
• Inferred reduction in referrals to urology by family physicians as a result of a low-Risk Score from ClarityDX Prostate [Time frame: 12 months]
• Comparison of associated healthcare costs with and without the use of ClarityDX Prostate [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• Unwilling to participate in the study
• Unable to consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

Canada · 5 centers

• Prostate Cancer Centre — Calgary
• Kipnes Urology Centre — Edmonton
• Vancouver Prostate Center — Vancouver
• Men's Health Clinic, Manitoba — Winnipeg
• Mount Sinai Hospital — Toronto

Publications

• Hyndman ME, Paproski RJ, Kinnaird A, Fairey A, Marks L, Pavlovich CP, Fletcher SA, Zachoval R, Adamcova V, Stejskal J, Aprikian A, Wallis CJD, Pink D, Vasquez C, Beatty PH, Lewis JD. Development of an effective predictive screening tool for prostate cancer using the ClarityDX machine learning platform. NPJ Digit Med. 2024 Jun 20;7(1):163. doi: 10.1038/s41746-024-01167-9. PMID 38902526

Identifiers

NCT: NCT06678828 · APCaRI-08

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗