Ángel Borque-Fernando1, José Rubio-Briones2, Luis M Esteban3, Yan Dong4, Ana Calatrava5, Álvaro Gómez-Ferrer2, Enrique Gómez-Gómez6, Jesús M Gil Fabra7, Nuria Rodríguez-García8, Pedro Á López González9, Jorge García-Rodríguez10, Miguel Rodrigo-Aliaga11, Bernardo Herrera-Imbroda12, Juan Soto-Villalba13, Sara Martínez-Breijo14, Virginia Hernández-Cañas15, Ana M Soto-Poveda16, Carlos Sánchez-Rodríguez17, Carlos Carrillo-George18, Yumaira E Hernández-Martínez19, David Okrongly20. 1. Department of Urology, Hospital Universitario Miguel Servet. IIS Aragon., Zaragoza, Spain. aborque@comz.org. 2. Department of Urology, Instituto Valenciano de Oncología, Valencia, Spain. 3. Escuela Universitaria Politécnica La Almunia, Universidad de Zaragoza, Zaragoza, Spain. 4. OPKO Diagnostics, Woburn, MA, USA. 5. Department of Pathology, Instituto Valenciano de Oncología, Valencia, Spain. 6. Department of Urology, Hospital Reina Sofía. IMIBIC, Córdoba, Spain. 7. Department of Urology, Hospital Universitario Miguel Servet. IIS Aragon., Zaragoza, Spain. 8. Department of Urology, Hospital Son Llàtzer, Palma de Mallorca, Spain. 9. Department of Urology, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain. 10. Department of Urology, Hospital Universitario Central de Asturias, Oviedo, Spain. 11. Department of Urology, Hospital General Universitario de Castellón, Castellón de La Plana, Spain. 12. Department of Urology, Hospital Universitario Virgen de la Victoria, Málaga, Spain. 13. Department of Urology, Hospital Universitario Puerta del Mar, Cádiz, Spain. 14. Department of Urology, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain. 15. Department of Urology, Hospital Universitario Fundación Alcorcón, Madrid, Spain. 16. Department of Urology, Hospital de Manises, Valencia, Spain. 17. Department of Urology, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Spain. 18. Department of Urology, Hospital General Universitario Morales Meseguer, Murcia, Spain. 19. Department of Urology, Hospital de Manacor, Manacor, Spain. 20. OPKO Diagnostics, Miami, FL, USA.
Abstract
BACKGROUND: Management of active surveillance (AS) in low-risk prostate cancer (PCa) patients could be improved with new biomarkers, such as the 4Kscore test. We analyze its ability to predict tumor reclassification by upgrading at the confirmatory biopsy at 6 months. METHODS: Observational, prospective, blinded, and non-randomized study, within the Spanish National Registry on AS (AEU/PIEM/2014/0001; NCT02865330) with 181 patients included after initial Bx and inclusion criteria: PSA ≤10 ng/mL, cT1c-T2a, Grade group 1, ≤2 cores, and ≤5 mm/50% length core involved. Central pathological review of initial and confirmatory Bx was performed on all biopsy specimens. Plasma was collected 6 months after initial Bx and just before confirmatory Bx to determine 4Kscore result. In order to predict reclassification defined as Grade group ≥2, we analyzed 4Kscore, percent free to total (%f/t) PSA ratio, prostate volume, PSA density, family history, body mass index, initial Bx, total cores, initial Bx positive cores, initial Bx % of positive cores, initial Bx maximum cancer core length and initial Bx cancer % involvement. Wilcoxon rank-sum test, non-parametric trend test or Fisher's exact test, as appropriate established differences between groups of reclassification. RESULTS: A total of 137 patients met inclusion criteria. Eighteen patients (13.1%) were reclassified at confirmatory Bx. The %f/t PSA ratio and 4Kscore showed differences between the groups of reclassification (Yes/No). Using 7.5% as cutoff for the 4Kscore, we found a sensitivity of 89% and a specificity of 29%, with no reclassifications to Grade group 3 for patients with 4Kscore below 7.5% and 2 (6%) missed Grade group 2 reclassified patients. Using this threshold value there is a biopsy reduction of 27%. Additionally, 4Kscore was also associated with changes in tumor volume. CONCLUSIONS: Our preliminary findings suggest that the 4Kscore may be a useful tool in the decision-making process to perform a confirmatory Bx in active surveillance management.
BACKGROUND: Management of active surveillance (AS) in low-risk prostate cancer (PCa) patients could be improved with new biomarkers, such as the 4Kscore test. We analyze its ability to predict tumor reclassification by upgrading at the confirmatory biopsy at 6 months. METHODS: Observational, prospective, blinded, and non-randomized study, within the Spanish National Registry on AS (AEU/PIEM/2014/0001; NCT02865330) with 181 patients included after initial Bx and inclusion criteria: PSA ≤10 ng/mL, cT1c-T2a, Grade group 1, ≤2 cores, and ≤5 mm/50% length core involved. Central pathological review of initial and confirmatory Bx was performed on all biopsy specimens. Plasma was collected 6 months after initial Bx and just before confirmatory Bx to determine 4Kscore result. In order to predict reclassification defined as Grade group ≥2, we analyzed 4Kscore, percent free to total (%f/t) PSA ratio, prostate volume, PSA density, family history, body mass index, initial Bx, total cores, initial Bx positive cores, initial Bx % of positive cores, initial Bx maximum cancer core length and initial Bx cancer % involvement. Wilcoxon rank-sum test, non-parametric trend test or Fisher's exact test, as appropriate established differences between groups of reclassification. RESULTS: A total of 137 patients met inclusion criteria. Eighteen patients (13.1%) were reclassified at confirmatory Bx. The %f/t PSA ratio and 4Kscore showed differences between the groups of reclassification (Yes/No). Using 7.5% as cutoff for the 4Kscore, we found a sensitivity of 89% and a specificity of 29%, with no reclassifications to Grade group 3 for patients with 4Kscore below 7.5% and 2 (6%) missed Grade group 2 reclassified patients. Using this threshold value there is a biopsy reduction of 27%. Additionally, 4Kscore was also associated with changes in tumor volume. CONCLUSIONS: Our preliminary findings suggest that the 4Kscore may be a useful tool in the decision-making process to perform a confirmatory Bx in active surveillance management.
Authors: Joseba Salguero; Enrique Gómez-Gómez; José Valero-Rosa; Julia Carrasco-Valiente; Juan Mesa; Cristina Martin; Juan Pablo Campos-Hernández; Juan Manuel Rubio; Daniel López; María José Requena Journal: Korean J Radiol Date: 2020-11-26 Impact factor: 3.500
Authors: Belén Pastor-Navarro; José Rubio-Briones; Ángel Borque-Fernando; Luis M Esteban; Jose Luis Dominguez-Escrig; José Antonio López-Guerrero Journal: Int J Mol Sci Date: 2021-06-10 Impact factor: 5.923