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Enrolling by Invitation

NCT Number: NCT06678828

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Screening Prostate Cancer Screening Decision Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prostate Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ClarityDX Prostate

Other

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.

ClarityDX Prostate, blinded

Other

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.

Primary outcomes

  1. Proportion of patients who receive biopsy and are not diagnosed with clinically significant prostate cancer

    Time frame: 12 months

    'Not diagnosed with clinically significant prostate cancer' refers to biopsies that show no cancer or clinically insignificant cancer

Secondary outcomes

  1. Proportion of patients diagnosed with clinically significant prostate cancer

    Time frame: 12 months

  2. Proportion of patients who undergo advanced imaging

    Time frame: 12 months

  3. Proportion of patients who undergo biopsy

    Time frame: 12 months

  4. Time from first urologist consultation to clinically significant prostate cancer diagnosis

    Time frame: 12 months

    Time in days from seeing urologist for the first time to getting diagnosed with cancer

  5. Number of biopsies deferred

    Time frame: 12 months

    A biopsy deferred is a biopsy that was ordered by the physicians but was not performed

  6. Inferred usability of ClarityDX Prostate for prostate cancer screening prior to urology referral

    Time frame: 12 months

  7. Inferred reduction in referrals to urology by family physicians as a result of a low-Risk Score from ClarityDX Prostate

    Time frame: 12 months

  8. Comparison of associated healthcare costs with and without the use of ClarityDX Prostate

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Nanostics

Industry

Registry information

Official study title

Establishing the Clinical Utility of ClarityDX Prostate

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 7, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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