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).
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 a man aged 18 or older.
I was referred to a urologist because of suspected prostate cancer.
Exclusion Criteria
I do not want to participate in the study.
I am unable to give consent by myself.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Group I: The controlExperimental Treatment1 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 and /or biopsy based on standard clinical criteria. Once the care path has been decided upon, the results of the ClarityDX Prostate will be shared.
Group II: ClarityDX ProstateExperimental Treatment1 Intervention
The report will be shared for participants randomized into ClarityDX Prostate arm before the healthcare team decided if an MRI and/or biopsy should be done.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Prostate Cancer CentreCalgary, Canada
Kipnes Urology CentreEdmonton, Canada
Loading ...
Who is running the clinical trial?
NanosticsLead Sponsor
Alberta Health servicesCollaborator