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.
Recommendations for the management of patients' preanalytical variables in Psa assessment for prostate cancer screening and follow-up / Polilli, E.; Cappelletti, P.; Barocci, S.; Caruso, B.; Del Ben, F.; Di Vincenzo, V.; Dorizzi, R.; Impicciatore, G.; Laneve, M.; Marin, M. G.; Martinotti, S.; Moretti, M.; Pasini, L.; Procopio, A. D.; Stenner, E.; Testa, R.; Toffalori, E.; Toniato, E.; Vero, A.; Golato, M.. - In: LA RIVISTA ITALIANA DELLA MEDICINA DI LABORATORIO. - ISSN 1825-859X. - 16:1(2020), pp. 60-72. [10.23736/S1825-859X.20.00047-X]
Recommendations for the management of patients' preanalytical variables in Psa assessment for prostate cancer screening and follow-up
Procopio A. D.;
2020-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
