AzTrials
AzTrials

Prostate CancerNCT06678828

Clinical Utility of ClarityDX Prostate

A study testing ClarityDX Prostate and ClarityDX Prostate, blinded in people with Prostate Cancer and Prostate Cancer Screening Decision, run by Nanostics at 5 sites in Canada.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
ClarityDX Prostate and ClarityDX Prostate, blinded
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,450 participants
Where
5 sitesCanada
Study dates
14 Apr 2025to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Unwilling to participate in the study
  • Unable to consent

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

Canada5 sites

  • Prostate Cancer Centre

    Calgary, Alberta

  • Kipnes Urology Centre

    Edmonton, Alberta, T6G 1Z1

  • Mount Sinai Hospital

    Toronto, Ontario

  • Vancouver Prostate Center

    Vancouver, British Columbia

  • Men's Health Clinic, Manitoba

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: 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:

Read more
  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).
Read the 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.

Being tested
ClarityDX Prostate, ClarityDX Prostate, blinded
Keywords
ClarityDX Prostate, Utility Study, Clinical Utility of ClarityDX Prostate, Establishing the Clinical Utility of ClarityDX Prostate, Prostate Cancer Screening, Prostate Cancer, Decision support tool
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClarityDX ProstateOther

    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, blindedOther

    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.

Study groups in NCT06678828
Study groupRoleWhat they receive
Blinded ControlOtherControl/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.
Receives: Other: ClarityDX Prostate, blinded
ClarityDX ProstateExperimentalThe 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.
Receives: Other: ClarityDX Prostate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

Secondary outcomes (8)

  1. Proportion of patients diagnosed with clinically significant prostate cancer

    Measured: 12 months

  2. Proportion of patients who undergo advanced imaging

    Measured: 12 months

  3. Proportion of patients who undergo biopsy

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. Number of biopsies deferred

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2024
  2. Study start14 Apr 2025
  3. Primary completionOct 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06678828
Sponsor's protocol ID
APCaRI-08
Status last verified
Jul 2026
First submitted
26 Sep 2024
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 38902526

Questions about this trial

What is this clinical trial studying?

A study testing ClarityDX Prostate and ClarityDX Prostate, blinded in people with Prostate Cancer and Prostate Cancer Screening Decision, run by Nanostics at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who receive biopsy and are not diagnosed with clinically significant prostate cancer (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06678828, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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