TY - JOUR
T1 - IsoPSA Performance Characteristics are Unaffected by 5-Alpha Reductase Inhibitors or Alpha-Blockers
T2 - Results From the IsoPSA Validation Study
AU - Scovell, Jason M.
AU - Stovsky, Mark
AU - Partin, Alan
AU - Lotan, Yair
AU - Baniel, Jack
AU - Dineen, Martin
AU - Hafron, Jason
AU - Manickam, Kannan
AU - Pliskin, Marc
AU - Wagner, Matthew
AU - Kestranek, Aimee
AU - Klein, Eric A.
N1 - Funding Information:
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.
Publisher Copyright:
© 2023 The Authors
PY - 2023/5
Y1 - 2023/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85151476080&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85151476080&partnerID=8YFLogxK
U2 - 10.1016/j.urology.2023.01.037
DO - 10.1016/j.urology.2023.01.037
M3 - Article
C2 - 36804443
AN - SCOPUS:85151476080
SN - 0090-4295
VL - 175
SP - 132
EP - 136
JO - Urology
JF - Urology
ER -