Evidence map›Paper›PMID 30108375›Full record

ArticleProstate cancer and prostatic diseases2019

Role of the 4Kscore test as a predictor of reclassification in prostate cancer active surveillance.

Ángel Borque-Fernando, José Rubio-Briones, Luis M Esteban, Yan Dong, Ana Calatrava, Álvaro Gómez-Ferrer, Enrique Gómez-Gómez, Jesús M Gil Fabra, Nuria Rodríguez-García, Pedro Á López González and 11 more

Registry-linked trialAbstract read
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In one paragraph

Article in Prostate cancer and prostatic diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02865330 (Spanish Urological Association Registry of Patients on Active Surveillance), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02865330 recruitingnot on this map

Spanish Urological Association Registry of Patients on Active Surveillance

Typeobservational_patient_registrySponsorFundación Instituto Valenciano de OncologíaRan2014 to 2034Enrolled946ConditionsProstate CancerArmsRegistry
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  12. Using active surveillance for Gleason 7 (3+4) prostate cancer: A narrative review.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2024
    Review
  13. Article
  14. Review
  15. Article
  16. [Active surveillance in prostate cancer].Der Urologe. Ausg. A · 2019
    Review
  17. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Ángel Borque-FernandoDepartment of Urology, Hospital Universitario Miguel Servet. IIS Aragon., Zaragoza, Spain. aborque@comz.org.ORCID http://orcid.org/0000-0003-0178-4567
José Rubio-BrionesDepartment of Urology, Instituto Valenciano de Oncología, Valencia, Spain.
Luis M EstebanEscuela Universitaria Politécnica La Almunia, Universidad de Zaragoza, Zaragoza, Spain.ORCID http://orcid.org/0000-0002-3007-302X
Yan DongOPKO Diagnostics, Woburn, MA, USA.
Ana CalatravaDepartment of Pathology, Instituto Valenciano de Oncología, Valencia, Spain.
Álvaro Gómez-FerrerDepartment of Urology, Instituto Valenciano de Oncología, Valencia, Spain.
Enrique Gómez-GómezDepartment of Urology, Hospital Reina Sofía. IMIBIC, Córdoba, Spain.
Jesús M Gil FabraDepartment of Urology, Hospital Universitario Miguel Servet. IIS Aragon., Zaragoza, Spain.
Nuria Rodríguez-GarcíaDepartment of Urology, Hospital Son Llàtzer, Palma de Mallorca, Spain.
Pedro Á López GonzálezDepartment of Urology, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain.
Jorge García-RodríguezDepartment of Urology, Hospital Universitario Central de Asturias, Oviedo, Spain.
Miguel Rodrigo-AliagaDepartment of Urology, Hospital General Universitario de Castellón, Castellón de La Plana, Spain.
Bernardo Herrera-ImbrodaDepartment of Urology, Hospital Universitario Virgen de la Victoria, Málaga, Spain.
Juan Soto-VillalbaDepartment of Urology, Hospital Universitario Puerta del Mar, Cádiz, Spain.ORCID http://orcid.org/0000-0003-4309-5778
Sara Martínez-BreijoDepartment of Urology, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.
Virginia Hernández-CañasDepartment of Urology, Hospital Universitario Fundación Alcorcón, Madrid, Spain.
Ana M Soto-PovedaDepartment of Urology, Hospital de Manises, Valencia, Spain.
Carlos Sánchez-RodríguezDepartment of Urology, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Spain.
Carlos Carrillo-GeorgeDepartment of Urology, Hospital General Universitario Morales Meseguer, Murcia, Spain.
Yumaira E Hernández-MartínezDepartment of Urology, Hospital de Manacor, Manacor, Spain.
David OkronglyOPKO Diagnostics, Miami, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundManagement 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.

methodsObservational, 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.

resultsA 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.

conclusionsOur 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.

Indexed as

AgedBiomarkersBiopsyHumansMaleMiddle AgedNeoplasm GradingNeoplasm StagingOdds RatioPopulation SurveillancePrognosisProstatic NeoplasmsRisk AssessmentRisk FactorsSensitivity and SpecificityBiomarkers

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