Establishing the Clinical Utility of ClarityDX Prostate

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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: 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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Prostate Cancer Centre
RECRUITING
Calgary
Kipnes Urology Centre
RECRUITING
Edmonton
Contact Information
Primary
Catalina Vasquez, MSc. C.Mgr.
info@nanosticsdx.com
800-672-2027
Backup
Juliana Valencia, PhD
info@nanosticsdx.com
800-672-2027
Time Frame
Start Date: 2025-04-14
Estimated Completion Date: 2028-12
Participants
Target number of participants: 1074
Treatments
Other: The control
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.
Experimental: ClarityDX Prostate
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.
Related Therapeutic Areas
Sponsors
Leads: Nanostics

This content was sourced from clinicaltrials.gov