Clinical Utility of ClarityDX Prostate

Establishing the Clinical Utility of ClarityDX Prostate

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Prostate Cancer; Prostate Cancer Screening; Prostate Cancer Screening Decision
• Intervention / Treatment: Other: ClarityDX Prostate, blinded; Other: ClarityDX Prostate

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.

• Study Type: Interventional
• Enrollment (Estimated): 1450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Prostate Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z1
      • Kipnes Urology Centre
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vancouver Prostate Center
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Men's Health Clinic, Manitoba
  • Ontario
    • Toronto, Ontario, Canada
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who receive biopsy and are not diagnosed with clinically significant prostate cancer	'Not diagnosed with clinically significant prostate cancer' refers to biopsies that show no cancer or clinically insignificant cancer	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients diagnosed with clinically significant prostate cancer		12 months
Proportion of patients who undergo biopsy		12 months
Time from first urologist consultation to clinically significant prostate cancer diagnosis	Time in days from seeing urologist for the first time to getting diagnosed with cancer	12 months
Number of biopsies deferred	A biopsy deferred is a biopsy that was ordered by the physicians but was not performed	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
Proportion of patients who undergo advanced imaging		12 months

Collaborators and Investigators

• Sponsor: Nanostics
• Collaborators: Alberta Health services
• Investigators: Principal Investigator: Adam Kinnaird, MD PhD FRCSC, Kipnes Urology Center; Principal Investigator: M Eric Hyndman, MD, PhD, FRCSC, Prostate Cancer Center; Principal Investigator: Jasmir Nayak, MD FRCSC FACS, Men's Health Clinic, Manitoba; Principal Investigator: Christopher Wallis, MD PhD FRCSC, Mount Sinai Hospital; Principal Investigator: Miles Mannas, MD MSc FRCSC, Vancouver Prostate Center

Publications and helpful links

General 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.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; ClarityDX Prostate; Decision support tool; Prostate Cancer Screening; Utility Study; Clinical Utility of ClarityDX Prostate; Establishing the Clinical Utility of ClarityDX Prostate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: APCaRI-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No