TY - JOUR
T1 - A 4Kscore Cut-off of 7.5% for Prostate Biopsy Decisions Provides High Sensitivity and Negative Predictive Value for Significant Prostate Cancer
AU - Bhattu, Amit S.
AU - Zappala, Stephen M.
AU - Parekh, Dipen J.
AU - Punnen, Sanoj
N1 - Funding Information:
The authors acknowledge the collaborators including Daniel D. Sjoberg, Scott W. Asroff, James L. Bailen, James S. Cochran, Raoul Concepcion, Richard D. David, Kenneth B. Deck, Igor Dumbadze, Michael Gambla, Michael S. Grable, Ralph J. Henderson, Lawrence Karsh, Evan B. Krisch, Timothy D. Langford, Daniel W. Lin, Shawn M. McGee, John J. Munoz, Christopher M. Pieczonka, Kimberley Rieger-Christ, Daniel R. Saltzstein, John W. Scott, Neal D. Shore, Paul R. Sieber, Todd M. Waldmann, Fredrick N. Wolk, Stephen J. Freedland, Thomas J. Polascik, Stacy Loeb, Michael C. Risk, Stephen Savage, Sharad C. Mathur, Edward Uchio, Jonathan L. Silberstein. Funding disclosure: The authors declare that they have no relevant financial interests.
PY - 2021/2
Y1 - 2021/2
N2 - OBJECTIVE: To evaluate the 4Kscore test's low risk cut-off of 7.5% as the indication to proceed with a prostate biopsy by combining data from 2 independent prospective multicentre trials in the United States which have validated the 4Kscore test as a continuous score to predict clinically significant prostate cancer. MATERIALS AND METHODS: We analyzed the data from 2 prospective multicenter trials in the United states to determine the number of men who could safely avoid a prostate biopsy and the presence of clinically significant cancers detected, at a 4Kscore cut-off of 7.5%. We evaluated this in the entire cohort, and 3 subgroups of men aged 45-75 years with a total prostate specific antigen between 3.0 and 10.0 ng/mL, African American, and non-African American men. RESULTS: The analysis included 1378 patients. The combination analysis at a 7.5% threshold to decide upon a prostate biopsy, was associated with a 32% biopsy reduction. A total of 21 men (4.8%) with a low risk 4Kscore had International society of Urological Pathology, prostate cancer Grade group (GG) 2 or 3 cancer, leading to a sensitivity of 94% for detecting GG ≥2 cancer, and a negative predictive value of 95%. There were no GG ≥4 cancers with a low risk 4Kscore. Analyses in various subgroups afforded similar results. CONCLUSION: A 4Kscore test cut-off of 7.5% allowed a significant biopsy reduction, while maintaining high sensitivity and NPV for detecting and ruling out aggressive prostate cancer.
AB - OBJECTIVE: To evaluate the 4Kscore test's low risk cut-off of 7.5% as the indication to proceed with a prostate biopsy by combining data from 2 independent prospective multicentre trials in the United States which have validated the 4Kscore test as a continuous score to predict clinically significant prostate cancer. MATERIALS AND METHODS: We analyzed the data from 2 prospective multicenter trials in the United states to determine the number of men who could safely avoid a prostate biopsy and the presence of clinically significant cancers detected, at a 4Kscore cut-off of 7.5%. We evaluated this in the entire cohort, and 3 subgroups of men aged 45-75 years with a total prostate specific antigen between 3.0 and 10.0 ng/mL, African American, and non-African American men. RESULTS: The analysis included 1378 patients. The combination analysis at a 7.5% threshold to decide upon a prostate biopsy, was associated with a 32% biopsy reduction. A total of 21 men (4.8%) with a low risk 4Kscore had International society of Urological Pathology, prostate cancer Grade group (GG) 2 or 3 cancer, leading to a sensitivity of 94% for detecting GG ≥2 cancer, and a negative predictive value of 95%. There were no GG ≥4 cancers with a low risk 4Kscore. Analyses in various subgroups afforded similar results. CONCLUSION: A 4Kscore test cut-off of 7.5% allowed a significant biopsy reduction, while maintaining high sensitivity and NPV for detecting and ruling out aggressive prostate cancer.
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U2 - 10.1016/j.urology.2020.11.008
DO - 10.1016/j.urology.2020.11.008
M3 - Article
C2 - 33217456
AN - SCOPUS:85096878592
VL - 148
SP - 53
EP - 58
JO - Urology
JF - Urology
SN - 0090-4295
ER -