A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening

Study Overview
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Brief Summary
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To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) comparing to prostate biopsy within the intended use population.

Detailed Description
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To determine the clinical performance of a blood-based test for clinically significant (CS) prostate cancer (PCa) (grade group ≥ 2) intended for use in men with prostate serum antigen levels in the 'grey zone' (PSA < 10 ng/ml). The test quantifies a previously described 3.4 kb mitochondrial DNA (mtDNA) deletion.

Official Title
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A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Mitomic Prostate Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men of screening age (≧45) who are scheduled for prostate needle biopsy due to suspicion of prostate cancer and have a total PSA < 10ng/ml within the previous 3 months. Extended Sextant biopsy pattern that must include a minimum of 12 cores. MRI targeted biopsy preferred where available. Age, total PSA, biopsy pathology, prostate medication history, and ethnicity data must be available; The index biopsy must occur following and within 16 weeks of blood draw. Exclusion Criteria: Subject does not undergo their prostate biopsy within 16 weeks of collection of pre-biopsy blood sample; Previous diagnosis of prostate cancer; Prostate biopsy within the previous 3 months; Men with a total PSA>10ng/ml within the previous 3 months; Provides less than the required amount of blood; Considered incompetent to provide informed consent; Does not understand and read language of informed consent; Age, total PSA, biopsy pathology information, medication history or ethnicity data unavailable; Males who are not of screening age (<45); Subjects whose classification as cancer positive or negative is undetermined following biopsy due to suspicious results such as Atypical Suspicious Acinar Proliferation (ASAP); Blood collected after index biopsy. Subject is taking antibiotics at the time of blood collection or has taken antibiotics within the 2 weeks prior to blood collection.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Mitomic Prostate Test|Mitomic Prostate Test|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitomic Prostate Test (MPT) | To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) within the intended use population. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MPT compared to the current standard of care (SOC). | To evaluate optimal disease screening strategies incorporating MPT compared to the current standard of care (SOC). | 16 weeks |