Abstract
Objective
To assess how IsoPSA, a structure-based serum assay which has been prospectively validated
in detecting clinically significant prostate cancer (csPCa), can help the biopsy decision
process when combined with the prostate imaging reporting and data systems (PI-RADS).
Materials and Methods
This was a single-center retrospective review of prospectively collected data on patients
receiving IsoPSA testing for elevated PSA (>4.0ng/mL). Patients were included if they
had received an IsoPSA test and prostate MRI within 1 year of IsoPSA testing, and
subsequently underwent prostate biopsy. Multivariable logistic regression was used
to identify predictors of (csPCa, ie, GG ≥ 2) on biopsy. Predictive probabilities
for csPCa at biopsy were generated using IsoPSA and various PI-RADS scores.
Results
Two hundred and 7 patients were included. Twenty-two percent had csPCa. Elevated IsoPSA
ratio (defined as ≥6.0) (OR: 5.06, P = .015) and a PI-RADS 4-5 (OR: 6.37, P <.001) were significant predictors of csPCa. The combination of elevated IsoPSA ratio
and PI-RADS 4-5 lesion had the highest area under the curve (AUC) (AUC: 0.83, P <.001). The predicted probability of csPCa when a patient had a negative or equivocal
MRI (PI-RADS 1-3) and a low IsoPSA ratio (≤6) was <5%.
Conclusion
The combination of PI-RADS with IsoPSA ratios may help refine the biopsy decision-making
process. In our cohort, a negative or equivocal MRI with a low IsoPSA may provide
a low enough predicted probability to omit biopsy in such patients.
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Article info
Publication history
Published online: March 23, 2023
Accepted:
March 12,
2023
Received:
January 4,
2023
Publication stage
In Press Journal Pre-ProofFootnotes
Financial Disclosure: All conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Petar Bajic, Andrei Purysko, Jane Nguyen, Jihad Kaouk, Georges-Pascal Haber, Mohamed Eltemamy, Robert Stein, Samuel Haywood, Eric A. Klein, Nima Almassi, Steven C. Campbell, Robert Abouassaly, and Christopher Weight work or have worked at Cleveland Clinic which has an equity position in Cleveland Diagnostics, but none have a direct or indirect personal financial interest in the company. Eric Klein is a consultant for Cleveland Diagnostics. The remaining authors have nothing to disclose.
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