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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, ClarityDX Prostate, designed to help doctors decide who needs further tests for prostate cancer. It uses various models to assess risk, based on factors like PSA levels (a protein made by prostate cells) and MRI scans. The goal is to determine if this tool can reduce unnecessary procedures and focus care on those most at risk. Men referred to a urology clinic due to suspected prostate cancer might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance prostate cancer diagnosis and care.

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.

What prior data suggests that the ClarityDX Prostate models are safe for use in prostate cancer risk assessment?

Research has shown that ClarityDX Prostate helps predict the risk of serious prostate cancer. It analyzes data using computer programs to provide a risk score, aiding doctors in deciding whether further tests, such as MRI scans or biopsies, are necessary.

ClarityDX Prostate is not a drug or treatment, so it does not pose the same safety concerns. It uses existing data, like PSA levels and MRI results, to generate a risk score, resulting in no physical side effects from the tool itself.

Past studies found the tool to be highly accurate, with a sensitivity of 95%. This indicates it effectively identifies individuals with high-risk cancer. While it does not directly impact health like a drug, it supports safer, informed decisions about additional testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ClarityDX Prostate because it offers a new way to decide if prostate cancer patients need an MRI or biopsy. Unlike the standard approach, which relies heavily on standard clinical criteria to make these decisions, ClarityDX Prostate provides a specific test whose results are shared with healthcare teams to guide more personalized care. This could mean fewer unnecessary procedures and a more tailored treatment path for patients, potentially improving outcomes and reducing anxiety.

What evidence suggests that ClarityDX Prostate is effective for prostate cancer?

Research has shown that ClarityDX Prostate effectively predicts the risk of serious prostate cancer. In studies, it correctly identified 95% of individuals with high-risk cancer, demonstrating 95% sensitivity. Its specificity was 35%, meaning it could rule out 35% of cases that are not high-risk. This tool surpasses traditional PSA tests alone in predicting serious prostate cancer. In this trial, participants in the ClarityDX Prostate arm will have their test results shared with their healthcare team to help determine who might need further tests like MRIs or biopsies. Meanwhile, participants in the control arm will have their results unblinded at the 12-month follow-up to assess any changes needed in their care path. ^{2 3 5 6 7}

Who Is on the Research Team?

Adam Kinnaird, MD

Principal Investigator

University of Alberta

M Eric Hyndman, MD, PhD, FRCSC

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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 am willing to participate in the study.

Availability for cancer care in the jurisdiction of recruitment

I have never been diagnosed with prostate cancer.

Exclusion Criteria

I am unable to give consent by myself.

I do not want to participate in the study.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. nature.com nature.com/articles/s41746-024-01167-9

Development of an effective predictive screening tool for ... When predicting high risk cancer in the validation cohort, ClarityDX Prostate showed 95% sensitivity, 35% specificity, 54% positive predictive ...

2. urologytimes.com urologytimes.com/view/published-data-show-value-of-claritydx-prostate-for-prostate-cancer-screening

Published data show value of ClarityDX Prostate for ... Overall, data from the study showed that at a threshold of 25% or greater, ClarityDX Prostate demonstrated a sensitivity of 95% and a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03957252

Validation of ClarityDX Prostate as a Reflex Test to Refine ... This study is designed to determine the accuracy of blood test ClarityDX Prostate to predict the results of prostate biopsies in men who have PSA (Prostate ...

4. targetedonc.com targetedonc.com/view/claritydx-prostate-utility-trial-enrolls-first-patient

ClarityDX Prostate Utility Trial Enrolls First Patient Overall, ClarityDX Prostate demonstrated superior predictive accuracy for clinically significant prostate cancer vs PSA testing alone and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38902526/

Development of an effective predictive screening tool for ... When predicting high risk cancer in the validation cohort, ClarityDX Prostate showed 95% sensitivity, 35% specificity, 54% positive predictive ...

6. proteanbiodx.com proteanbiodx.com/claritydx

Clarity DX for Prostate — Protean BioDx ClarityDX Prostate is a decision support tool that provides a risk score based on clinical and biological biomarkers.

7. nanosticsdx.com nanosticsdx.com/claritydx-prostate/

ORDER ClarityDX Prostate-Payment-Purchase- ... ClarityDX Prostate is a clinically proven decision support tool that uses a machine learning platform to calculate an accurate prostate cancer risk score.