IsoPSA Performance Characteristics are Unaffected by 5-Alpha Reductase Inhibitors or Alpha-Blockers: Results From the IsoPSA Validation Study - 29/05/23
ABSTRACT |
Objective |
To. determine the impact of 5-α reductase inhibitors or α-blockers on IsoPSA performance for the detection of actionable prostate cancer.
Materials and Methods |
This is a secondary analysis of data from an institutional review board approved, prospective, multicenter(8-sites) study evaluating IsoPSA in men ≥ 50 years of age with a total PSA ≥ 4 ng/mL with planned prostate biopsy who met previously described inclusion and exclusion criteria. Analytic groups included (i)all subjects, (ii-iii)+/- 5-ARI use, (iv-v)+/- α-blocker use. The performance characteristics of IsoPSA in these groups were assessed by ROC curve, sensitivity, and specificity (SP) analysis.
Results |
A total of 1385 men were recruited with 888 men included in final analysis. Actionable prostate cancer, defined as GG2+, was identified in a total of 316 patients with 40 and 217 patients reporting 5-ARI and α-blocker use respectively. Sensitivity to detect both prostate cancer and actionable cancer was similar between patient subsets (P >.05). SP was similar between patients regardless of 5-ARI(P >.05). Increased SP was noted in patients on α-blockers(GG1+: No-α-blocker: 0.360 vs α-blocker: 0.529, P <.05; GG2+: No-α-blocker: 0.40 vs α-blocker: 0.61, P <.05). ROC analysis demonstrates that IsoPSA performance is unaffected by 5-ARI or α-blocker use for prostate cancer and actionable cancer (GG2+) detection.
Conclusion |
The performance of IsoPSA for detecting any prostate cancer and clinically actionable prostate cancer is unaffected by commonly used medications (5-ARI and α-blockers) for symptoms of benign prostatic hyperplasia.
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| Financial Disclosure: AK and MS are employees of Cleveland Diagnostics, Inc. and hold equity positions in the company. JS and EAK are employees of the Cleveland Clinic, which holds an equity stake in Cleveland Diagnostics, Inc. EAK is a consultant to Cleveland Diagnostics. Cleveland Diagnostics, Inc. provided funding for study logistics and performed IsoPSA on clinical plasma specimens collected at study sites. Cleveland Diagnostics, Inc. participated in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation and review of the manuscript. |
Vol 175
P. 132-136 - maggio 2023 Ritorno al numero
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