ClarityDX Prostate for Prostate Cancer

Recruiting at 1 trial location

Overseen By Catalina Vasquez, MSc. C.Mgr.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Nanostics

Disqualifiers: Unwilling to participate, unable to consent

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

1074 Participants Needed

Trial Summary

What is the purpose of this trial?

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 on 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. 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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Research Team

M Eric Hyndman, MD, PhD, FRCSC

Principal Investigator

University of Calgary

Adam Kinnaird, MD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for men over 18 who are suspected of having prostate cancer and have been referred to a urology clinic. They should not have had a previous diagnosis of prostate cancer, must be willing to participate, and live where the study is taking place.

Inclusion Criteria

I have never been diagnosed with prostate cancer.

I am willing to participate in the study.

Availability for cancer care in the jurisdiction of recruitment

Exclusion Criteria

I do not want to participate in the study.

I am unable to give consent by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization

Participants are randomized into either the ClarityDX Prostate arm or the Standard of Care arm

1 week

Treatment

Participants in the ClarityDX Prostate arm receive the risk score report to guide decision-making on MRI/biopsy; Standard of Care arm follows usual clinical criteria

12 months

Regular visits as per clinical need

Follow-up

Participants are monitored for healthcare utilization and biopsy outcomes

12 months

Treatment Details

Interventions

• ClarityDX Prostate

Trial Overview The ClarityDX Prostate test is being studied. It's used alongside PSA levels, age, prior biopsy results, DRE findings, and MRI scans to assess the risk of significant prostate cancer. The goal is to see if this test reduces unnecessary biopsies or imaging.

Participant Groups

Group I: The control Experimental Treatment 1 Intervention

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.

Group II: ClarityDX Prostate Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Nanostics

Lead Sponsor

Trials

2

Recruited

3,900+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+