Indication - Cancer
Prostate-specific antigen (PSA)
Facility level:
Assay formats
Status history
First added in 2019
Changed in 2020
Purpose type
Aid to diagnosis, Monitoring, Prognosis
To aid in diagnosis, prognosis and monitoring of prostate cancer
Specimen types
Peripheral blood
WHO prequalified or recommended products
WHO supporting documents
WHO classification of tumours of the urinary system and male genital organs. WHO classification of tumours, 4th edition, volume 8 http://publications.iarc.fr/Book-And-Report-Series/Who-Iarc-Classification-Of-Tumours/Who-Classification-Of-Tumours-Of-The-Urinary-System-And-Male-Genital-Organs-2016
ICD11 code: 2C82.Z

Summary of evidence evaluation

While PSA has a stated role in prognostic models for recurrence, in the diagnostic workup of symptomatic patients and in post-treatment surveillance, the supporting evidence is poorly presented.

Summary of SAGE IVD deliberations

PSA is recommended for use in the diagnosis of prostate cancer and in risk stratification and surveillance. The levels of evidence for these recommendations are considered to be moderate to high.

SAGE IVD recommendation

SAGE IVD recommended that the test for determination of total PSA be included conditionally on the EDL, pending evidence for its use as an aid in the diagnosis of prostate cancer and for prognosis and monitoring, including triaging patients with newly diagnosed prostate cancer to decide on the intensity of treatment. The Group noted that the test is not suitable for use in screening or for a definitive diagnosis. The Group recommended that rapid, semi-quantitative point-of-care tests for use in primary care be evaluated at a future meeting.

Details of submission from 2020


Disease condition and impact on patients: Prostate cancer is the second most frequently diagnosed cancer in 105 countries, affecting 1.3 million men in 2018 (1). In low-income countries, prostate cancer is the most frequently diagnosed cancer in men and is associated with a poorer prognosis than in higher-income countries, with a mortality incidence ratio of 0.63, which is much higher than the average world ratio (0.27) and that in high-income countries (0.19). Prostate cancer is the leading cause of death from cancer in 46 countries, particularly in sub‐Saharan Africa and the Caribbean (2). Does this test meet a medical need? The role of PSA in the work-up and prognosis of prostate cancer has been evaluated in several studies, and PSA has been included in the prognostic risk score for localized prostate cancer for deciding whether to provide conservative (active surveillance) or interventional treatment, the intensity of interventions (surgery with or without radiation, hormone therapy or chemotherapy) and the type of intervention (surgery and/or radiation) (3, 4). The role of PSA in clinical diagnosis, staging, prognostication and monitoring of prostate cancer is recognized in all principal international, regional and national clinical guidelines. Use of a composite score for recurrence and clinical staging at presentation permits health care providers to discriminate between low- (87% recurrence-free) and high-risk patients (59% recurrence-free) as compared with patients treated by prostatectomy (5), with possible risk-adapted intensification of treatment with radiation therapy (4) or hormone therapy (6). PSA is also essential for following up patients. How this test is used: Included in the prognostic risk score for localized prostate cancer for deciding whether to provide conservative (active surveillance) or interventional treatment, the intensity of interventions and the type of intervention (surgery and/or radiation) (3, 4).

Public health relevance

Prevalence: Globally, 3.7 million patients today live with prostate cancer (2), with 70% of the prevalence reported in high-income countries, where the probability of survival is much higher as a result of timely access to early diagnosis and high- quality curative treatment. Socioeconomic impact: The age-standardized mortality from prostate cancer is highest in some African and Caribbean countries. For instance, sub-Saharan LMICs are most strongly affected, due to a combination of constraints in access to timely diagnosis and treatment and intrinsically more aggressive pathology

WHO or other clinical guidelines relevant to the test

PSA is included in WHO guidance on Priority medical devices for cancer management (6).

Evidence for clinical usefulness and impact

Treatments for localized prostate cancer are chosen on the basis of clinical and pathological features, and PSA provides essential information. Use of a composite clinical–pathological score to estimate the risk of recurrence, including histological grading on the basis of PSA results and clinical stage at presentation, allows health care providers to categorize cases into prognostic groups and to provide risk-adapted therapy (3–5). PSA is also essential in follow-up for biochemical relapse in patients who have undergone resection and for progression of disease in patients with metastases, in whom PSA recurrence often precedes clinical recurrence or resistance to therapy (7, 8).

Evidence for economic impact and/or cost–effectiveness

No analysis of the cost–effectiveness of PSA in the management of prostate cancer has been reported, although there are studies of its cost–effectiveness in screening. In view of the use of PSA in defining risk for recurrence, a cost– effectiveness study was conducted of active surveillance versus treatment of low-risk prostate cancer, which showed that conservative management of low- risk disease optimizes health outcomes and significantly reduces costs (9). The cost of a PSA test in both Italy and the USA is US$ 20–50. PSA testing requires a laboratory for diagnostics, with technicians; however, no additional training is required for following the instructions for testing provided by the manufacturers.

Ethical issues, equity and human rights issues

Consent is required to obtain a blood sample. PSA is not proposed for screening in asymptomatic populations in view of the lack of robust data that it reduces mortality from prostate cancer. A PSA programme for active surveillance of patients with low-risk, localized prostate cancer or with resection should be associated with a diagnostic facility for timely referral of those who are more likely to have progression or recurrence of disease. PSA can be used with pathological (Gleason score) and clinical monitoring (for co-morbid conditions) to personalize the treatment of prostate cancer and avoid overtreatment of indolent cancers. Thus, access and equity are assured by risk stratification, with more equitable treatment among population groups.
1. Global Cancer Observatory. Lyon: International Agency for Research on Cancer; 2019 (https://gco. iarc.fr/). 2. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clinicians. 2018;68(6):394–424. 3. D’Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998;280(11):969–74. 4. Antebi E, Eldefrawy A, Katkoori D, Soloway CT, Manoharan M, Soloway MS. Oncological and functional outcomes following open radical prostatectomy: how patients may achieve the “Trifecta”? Int Braz J Urol. 2011;37(3):320–7. 5. Denham JW, Steigler A, Lamb DS, Joseph D, Turner S, Matthews J, et al. Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial. Lancet Oncol. 2011;12(5):451–9. 6. Priority medical devices for cancer management (WHO Medical Device Technical Series). Geneva: World Health Organization; 2017 (http://www.who.int/medical_devices/publications/priority_ med_dev_cancer_management/en/). 7. Horwitz EM, Thames HD, Kuban DA, Levy LB, Kupelian PA, Martinez AA, et al. Definitions of biochemical failure that best predict clinical failure in patients with prostate cancer treated with external beam radiation alone: a multi-institutional pooled analysis. J Urol 2005;173(3): 797–802. 8. Stephenson AJ, Kattan MW, Eastham JA, Dotan ZA, Bianco FJ Jr, Lilja H, et al. Defining biochemical recurrence of prostate cancer after radical prostatectomy: a proposal for a standardized definition. J Clin Oncol. 2006;24(24):3973–8. 9. Prostate cancer guidelines. Arnhem: European Association of Urology; 2018 (https://uroweb.org/ guideline/prostate-cancer/).