Clinical Utility of ClarityDX Prostate

Summary

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).

Conditions

• 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 is a need to change the participant's care path.

Sponsors & Collaborators

• Nanostics

  lead INDUSTRY

Principal Investigators

• Adam Kinnaird, MD PhD FRCSC · University of Alberta

• M Eric Hyndman, MD, PhD, FRCSC · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-14

Primary Completion

2027-04-30

Completion

2028-12-31

Countries

• Canada

Study Locations