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 on 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.

This is a prospective, randomized, two-armed clinical utility study that will enroll participants referred to urology clinics for suspicion of prostate cancer. The arms of the study are ClarityDX Prostate and Standard of Care (SOC).

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.

Inclusion Criteria:

1. Males ≥ 18 years of age
2. Referred to urology for suspicion of prostate cancer
3. No prior prostate cancer diagnosis
4. Willing to participate in the study
5. Availability for cancer care in the jurisdiction of recruitment

Exclusion Criteria:

1. Unwilling to participate in the study
2. Unable to consent