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Prostate-Specific-Antigen (PSA) in Prostate Cancer Screening and Robot-Assisted Surgery

Submitted by on 06 Oct 2011 – 11:10

PSA in Prostate Cancer Screening and Robot-Assisted Surgery Dr Hans van Brabandt, Medical Doctor and Medical Expert at the Belgium Health Care Knowledge Centre, KCE

The present document summarises the conclusions of the 2006 report from the Belgian Health Care Knowledge Centre (KCE): “Prostate-specific-antigen (PSA) in prostate cancer screening”. In 2009,  KCE issued a report on “Robot-assisted surgery” which covered prostate surgery and indirectly PSA as well. Both reports are available from our website: www.kce.fgov.be.

The availability of a valid screening test is crucial to a screening program. The test’s sensitivity should be as high as possible in order to exclude cancer with confidence in those patients testing negative, while maintaining an acceptable specificity to minimise the number of patients testing falsely positive, thus avoiding further invasive procedures. Unfortunately, for a cut-off point of 4ng/ml, the diagnostic value of the total PSA level is insufficient for screening conditions, with sensitivity ranging from 20% in biopsy verified patients to 50% in patients eventually diagnosed with clinical prostate cancer. The test is not able to identify only those tumours that are clinically relevant, and thus may lead to over-diagnosis. There is insufficient evidence on other tests, such as the PSA velocity or free/total PSA.

Treatment alternatives are radical prostatectomy, radiotherapy or active surveillance. The standard curative treatments of prostate cancer are radical prostatectomy and radiotherapy (external or internal). The optimal treatment for localised stages with an intermediate or good prognosis (stage T1 to T2b, PSA<15 and Gleason ≤ 7) remains unknown. The treatment-induced harms for the patient vary greatly, but may affect the quality of life to a great extent. No convincing evidence was found that screening decreases disease-specific mortality.[1]

Given the current lack of evidence, it is impossible to estimate the cost-effectiveness of prostate cancer screening with the PSA test.

A screening recommendation is only justified if the benefits of earlier detection by the test can reasonably be expected to outweigh (1) the risks of over-treatment of true positives, (2) treatment of  false positives and (3) harms induced by false reassurance (in case of a high number of false negatives). According to different studies, as many as 18%–44% of men diagnosed with prostate cancer by PSA testing would be subjected to substantial and sometimes enduring treatment complications, without a proven benefit.

If physicians are steering a patient towards a certain diagnosis and treatment path, they also become ethically implicated and responsible for the likely outcome (both harms and benefits) of the treatment trajectory. From this responsibility, the least obligation of the physician is to inform the patient about benefits and potential harms and uncertainties of choices and decisions. Therefore, the potential for over-diagnosis should not be underestimated or overlooked. Only if the patient is clearly and well informed, he becomes co-responsible for the decision, as he should be aware of his right to refuse the test and treatment.

Mass media or marketing campaigns (possibly inspired by the availability of a surgical robot) urging asymptomatic men to ask for PSA-tests will lead to a further supplier-induced demand for the test and subsequent invasive treatment. The PSA test is considered more and more a routine test and the number of PSA tests shows an average annual increase of about 18% since 1995 in Belgium. Our estimations show that currently over half of all men above 50 undergo a PSA test. The uncertainties surrounding PSA screening can explain the discrepancy between the strong increase in the use of the PSA test and the more moderate increase in the use of biopsy and  prostate cancer treatment as found in the Belgian health insurance data.

[1]A study recently published in 2011 in BMJ confirms this finding: After 20 years of follow-up, the rate of death from prostate cancer did not differ significantly between men in the screening group and those in the control group (Sandblom et al., BMJ 2011;342:d1539).