NCT06678828

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. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,074

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
31mo left

Started Apr 2025

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Apr 2025Dec 2028

First Submitted

Initial submission to the registry

September 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

April 14, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

September 26, 2024

Last Update Submit

April 14, 2025

Conditions

Prostate Cancer

Keywords

ClarityDX ProstateUtility StudyClinical Utility of ClarityDX ProstateEstablishing the Clinical Utility of ClarityDX Prostate

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

  • +3 more secondary outcomes

Study Arms (2)

The control

OTHER

Control/Standard of Care arm- ClarityDX Prostate will be run for these participants. Participants and healthcare providers will be blinded to the results report and participants will be considered for prostate MRI/advanced imaging and /or biopsy based on standard clinical criteria. The results of the ClarityDX Prostate will be unblinded to the study teams at the 12 months follow-up visit. 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.

Other: ClarityDX Prostate, blinded

ClarityDX Prostate

EXPERIMENTAL

The report will be shared with the healthcare team of participants randomized into the ClarityDX Prostate arm before the healthcare team decides whether to perform an MRI/advanced imaging and/or biopsy.

Other: ClarityDX Prostate

Interventions

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
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.

The control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prostate Cancer Centre

Calgary, Alberta, Canada

RECRUITING

Kipnes Urology Centre

Edmonton, Alberta, T6G 1Z1, Canada

RECRUITING

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: 38902526BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Adam Kinnaird, MD PhD FRCSC

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • M Eric Hyndman, MD, PhD, FRCSC

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catalina Vasquez, MSc. C.Mgr.

CONTACT

800-672-2027info@nanosticsdx.com

Juliana Valencia, PhD

CONTACT

800-672-2027info@nanosticsdx.com

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)

April 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)