An interventional study of ClarityDX Prostate and ClarityDX Prostate, blinded in Prostate Cancer, Prostate Cancer Screening Decision and Prostate Cancer Screening, sponsored by Nanostics. Enrolling by invitation at 5 sites in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Nanostics · Not applicable, Interventional, and Screening
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:
PRIMARY OBJECTIVE The purpose of this study is to investigate the clinical utility of ClarityDX Prostate in reducing further healthcare utilization for men identified to be at risk of prostate cancer.
SECONDARY OBJECTIVES
DESIGN
When stratifying patients for prostate cancer, it is ideal to avoid delay in treating high-risk participants that do require a biopsy, while avoiding unnecessary procedures in low-risk patients. The purpose of this study is to investigate in a real-world setting whether the use of ClarityDX Prostate would further reduce potentially unnecessary healthcare utilization of men referred to urology clinics with suspicion of prostate cancer.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 1,450 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Nanostics is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Control/Standard of Care arm- ClarityDX Prostate will be run for these participants. Participants and healthcare providers will be blinded to the ClarityDX Prostate results for 12 months ± 2 months. Participants care path will be decided based on the current standard of care. The ClarityDX Prostate results will be unblinded to the study teams at the 12 months follow-up visit. The attending urologist may or may not change the decision on the tests or procedures prescribed after receiving the results of the ClarityDX Prostate test.
Other: ClarityDX Prostate, blinded
The results from ClarityDX Prostate will be given to the participant's healthcare team before before they see the participant to decide if an MRI/advanced imaging and/or biopsy should be done. The results of ClarityDX Prostate may or may not influence the decision on what other tests and/or procedures the participant will receive.
Other: ClarityDX Prostate
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 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.
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
Time frame: 12 months
Proportion of patients diagnosed with clinically significant prostate cancer
Time frame: 12 months
Proportion of patients who undergo advanced imaging
Time frame: 12 months
Proportion of patients who undergo biopsy
Time frame: 12 months
Time from first urologist consultation to clinically significant prostate cancer diagnosis
Time in days from seeing urologist for the first time to getting diagnosed with cancer
Time frame: 12 months
Number of biopsies deferred
A biopsy deferred is a biopsy that was ordered by the physicians but was not performed
Time frame: 12 months
Inferred usability of ClarityDX Prostate for prostate cancer screening prior to urology referral
Time frame: 12 months
Inferred reduction in referrals to urology by family physicians as a result of a low-Risk Score from ClarityDX Prostate
Time frame: 12 months
Comparison of associated healthcare costs with and without the use of ClarityDX Prostate
Time frame: 12 months
Plan to share: No
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