Clinical Utility of ClarityDX Prostate

NCT06678828 | Enrolling By Invitation DMC

• 1 other identifier: APCaRI-08
• Study Type: interventional
• Target: 1,450
• Locations: 1 country
• Sites: 5

Brief 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:

• 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).

Conditions

Prostate Cancer; Prostate Cancer Screening Decision; Prostate Cancer Screening

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

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (8)

• Proportion of patients diagnosed with clinically significant prostate cancer

  12 months

• Proportion of patients who undergo advanced imaging

  12 months

• Proportion of patients who undergo biopsy

  12 months

• Time from first urologist consultation to clinically significant prostate cancer diagnosis

  12 months

• Number of biopsies deferred

  12 months

Study Arms (2)

Blinded Control

OTHER

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

EXPERIMENTAL

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

Interventions

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

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.

Blinded Control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unwilling to participate in the study
• Unable to consent

Sponsors & Collaborators

• Nanostics: lead

Study Sites (5)

Prostate Cancer Centre

Calgary, Alberta, Canada

Location

Kipnes Urology Centre

Edmonton, Alberta, T6G 1Z1, Canada

Location

Vancouver Prostate Center

Vancouver, British Columbia, Canada

Location

Men's Health Clinic, Manitoba

Winnipeg, Manitoba, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 38902526 BACKGROUND

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: November 7, 2024
• Study Start: April 14, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)