Magnetic resonance imaging (MRI) has become the current standard of care in risk stratifying men with an elevated Prostate-specific antigen (PSA) to determine who needs to undergo prostate biopsy, which is invasive and carries a 3-5% risk of serious infection. Recent data shows the negative predictive value of MRI to be only 77%, indicating that some men may inappropriately forego biopsy based on a negative MRI. Urinary exosomes can be captured and analyzed by the ExosomeDx (ExoDx) Prostate test, a urine based, gene signature derived from PCA3 (prostate cancer antigen 3) and ERG (erythroblast transformation-specific related gene), and SPDEF (SAM pointed domain-containing ETS transcription factor); ExoDx carries a 90% negative predictive value. The use of ExoDx test among patients with negative MRIs has the potential to improve the risk stratification of patients with an elevated PSA in a way that the Urologist can more accurately determine which patients need to undergo prostate biopsy. In doing so, the Urologist can better risk-stratify which patients should undergo prostate biopsy and be exposed to the associated potential risks, and also be more confident about the safety of foregoing biopsy in those patients with negative MRI and negative ExoDx test.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
425
A urine sample for ExoDx Study Kit will be collected onsite and shipped to Exosome Diagnostic's laboratory.
Participants will be scheduled for transrectal ultrasound-guided prostate biopsy as per the standard diagnostic practice after urinary test.
Participants will be scheduled for transperineal 12-core prostate biopsy as per the standard diagnostic practice after urinary test.
Mount Sinai Beth Israel / Union Square
New York, New York, United States
Mount Sinai West
New York, New York, United States
Mount Sinai Morningside
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Mount Sinai Queens
New York, New York, United States
Mount Sinai Brooklyn
New York, New York, United States
Sensitivity
Sensitivity is defined as the probability that clinically significant cancer is detected when it is cancer. Sensitivity = true positive cases / true positive cases + false negative cases
Time frame: duration of study, average 3 months
Specificity
Specificity is defined as the probability that clinically significant cancer is not detected when it is not cancer. Specificity = true negative cases / true negative cases + false positive cases
Time frame: duration of study, average 3 months
Cancer Detection Rate
Cancer Detection Rate (CDR): Cancer detection rate is defined as the proportion of enrolled patients with histologically Gleason grade group 1+ cancers and as determined by the Investigator. Cancer detection rate = true positive (histologically Gleason grade 1+) / all tests performed
Time frame: duration of study, average 3 months
csPCa Detection Rate
csPCa Detection Rate (csCDR): clinically significant cancer detection rate is defined as the proportion of enrolled patients with histologically Gleason grade group 2+ cancers. csPCa detection rate = true positive (histologically Gleason grade 2+) / all tests performed
Time frame: duration of study, average 3 months
Biopsy aversion rate
Biopsy aversion rate is defined as the proportion of patients in whom the biopsy could have been potentially averted using ExosomeDx, as compared to decisions based on PSA density.
Time frame: duration of study, average 3 months
Net Benefit
Decision curve analysis will be used to calculate the net benefit of adding ExoDx to PSA density (including kinetics and density) and MRI in the diagnostic workflow following. Net benefit is calculated across a range of threshold probabilities, defined as the minimum probability of disease at which further intervention would be warranted, as net benefit = sensitivity × prevalence - (1 - specificity) × (1 - prevalence) × w where w is the odds at the threshold probability.
Time frame: duration of study, average 3 months
Diagnostic Accuracy
Accuracy is defined as the potential of ExoDx to correctly detect the presences or absence of disease. Diagnostic Accuracy = (True Positive) + True Negative / All) \* 100
Time frame: duration of study, average 3 months
Positive Predictive Value (PPV)
Positive predictive value is defined as the probability that an elevated ExoDx actually has cancer. Positive Predictive Value = (True Positive)/(True Positive + False Positive)
Time frame: duration of study, average 3 months
Negative Predictive Value (NPV)
Negative predictive value is defined as the probability a negative ExoDx test does not cancer. Negative Predictive Value = (True Negative)/(True Negative + False Negative)
Time frame: duration of study, average 3 months
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