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La Rivista Italiana della Medicina di Laboratorio 2020 Marzo;16(1):60-72

DOI: 10.23736/S1825-859X.20.00047-X

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: Italian

Recommendations for the management of patients’ preanalytical variables in PSA assessment for prostate cancer screening and follow-up

Ennio POLILLI 1 , Piero CAPPELLETTI 2, Simone BAROCCI 3, Beatrice CARUSO 4, Fabio DEL BEN 5, Valentina DI VINCENZO 6, Romolo DORIZZI 7, Gianna IMPICCIATORE 8, Mario LANEVE 9, Maria Grazia MARIN 10, Stefano MARTINOTTI 11, Marco MORETTI 12, Luciano PASINI 13, Antonio D. PROCOPIO 14, Elisabetta STENNER 15, Roberto TESTA 16, Emanuela TOFFALORI 17, Elena TONIATO 18, Anna VERO 19, Maria GOLATO 6

1 Unità Operativa Complessa Laboratorio Analisi Cliniche, ASL 03 Pescara, Pescara, Italia; 2 Società Italiana di Patologia Clinica e Medicinadi Laboratorio (SIPMeL), Castelfranco Veneto, Treviso, Italia; 3 Unità di Patologia Clinica, Dipartimento dei Servizi, ASUR Marche, Senigallia, Ancona, Italia; 4 Laboratorio di Chimica Clinica ed Ematologia, Azienda Ospedaliera, Verona, Italia; 5 Dipartimento di Area Medica, Azienda Sanitaria Universitaria Integrata, Udine, Italia; 6 Dipartimento di Patologia Clinica Aziendale, ASL 02 Lanciano-Vasto-Chieti, Ospedale Clinicizzato SS Annunziata, Chieti, Italia; 7 Unità di Patologia Clinica, AUSL Romagna, Pievesestina di Cesena, Forlì-Cesena, Italia; 8 Dipartimento di Ostetricia e Ginecologia, A.S.R.E.M. Molise, Presidio Ospedaliero S. Timoteo, Termoli, Italia; 9 Dipartimento di Medicina di Laboratorio, Presidio Ospedaliero Centrale SS. Annunziata, ASL di Taranto, Taranto, Italia; 10 Dipartimento di Patologia Clinica, Azienda Ospedaliera, Desenzano del Garda, Brescia, Italia; 11 Dipartimento di Patologia Clinica, Ospedale Clinicizzato SS. Annunziata, Università di Chieti, Chieti, Italia; 12 Dipartimento di Patologia Clinica, Azienda Ospedaliera Ospedali Riuniti di Ancona, Ancona, Italia; 13 Reparto di Patologia Clinica, Casa di Cura Giovanni XXIII, Monastier di Treviso, Treviso, Italia; 14 Università Politecnica delle Marche, Ancona, Italia; 15 Dipartimento di Patologia Clinica, Azienda Sanitaria Universitaria Integrata, Trieste, Italia; 16 Laboratorio Analisi Chimico Cliniche Molecolari, IRCCS-INRCA, Ancona, Italia; 17 Laboratorio di Biochimica ed Ematologia, Ospedale Santa Chiara, Trento, Italia; 18 Dipartimento di Medicina Sperimentale, Università di Chieti, Chieti, Italia; 19 Laboratorio Analisi Chimico Cliniche, Azienda Ospedaliera Pugliese Ciaccio, Catanzaro, Italia



BACKGROUND: Prostate-specific antigen (PSA) has been shown to be useful in the screening, diagnosis and staging of prostatic cancer as well as in monitoring response to therapy, although its use in screening of asymptomatic men is still under debate. Several pre-analytical and analytical factors may influence the serum level of PSA, and the patients’ pre-analytical factors (timing of sample collection after physiological and diagnostic events) are the most important ones. For these reasons, the SIPMeL Oncologic Diagnostics Study Group (GdS DO) suggests recommendations for the management of the main patients’ preanalytical variables in the determination of PSA (ejaculation, bicycle riding, digital rectal examination, rigid cystoscopy, needle biopsy).
METHODS: The SIPMeL GdS DO has compiled the recommendations on the basis of bibliographic research carried out on PubMed, using the criteria of strength of recommendations and level of evidence according to GRADE and by a modified Delphi method.
RESULTS: The GdS DO recommendations for the management of the main patients’ preanalytical variables are as follows:
• do not take the sample for PSA determination before 7 days after digital rectal examination (quality of evidence: very low; strength of recommendations: weak);
• do not take the sample for PSA determination before 24/48 hours after strong physical exercises (quality of evidence: very low; strength of recommendations: weak);
• do not take the sample for PSA determination before 24 hours after ejaculation (quality of evidence: very low; strength of recommendations: weak);
• do not take the sample for PSA determination before 6 weeks after needle biopsy (quality of evidence: very low; strength of recommendations: strong);
• do not take the sample for PSA determination before 3 weeks after rigid cystoscopy (quality of evidence: very low; strength of recommendations: weak).
CONCLUSIONS: The quality of evidences for the pre-analytical factors affecting the PSA determination is generally low or very low mainly because they are old and/or based on very few patients. Consequently, the recommendations are generally weak. Nevertheless, our recommendations are based on a cautious approach, so that an effective and safe outcome is warranted also when the preanalytical factors could interfere only in a small number of patients.


KEY WORDS: Prostate-specific antigen; Ejaculation; Bicycling; Digital rectal examination; Cystoscopy; Needle biopsy

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