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PSA Testing for Prostate Cancer in Asymptomatic Men: Information for Health Practitioners submission

ID: 
11
This submission reflects the views of
Organisation Name: 
Cancer Council Victoria's Clinical Network
Please identify the best term to describe the Organisation: 
Non-government organisation
Personal Details
Specific Questions
3. How frequent are these benefits and harms?: 

We have significant concerns regarding the figures quoted in this section:

  1. Overall figures are misleading, since they vary considerably with patient age, medical history, family history and other factors. Although quoted figures are meant to refer to low-risk men aged 60, although it is not defined what “low risk” means. Recommend including figures for other risk groups as well.
  2. Mortality reduction & other figures are derived from specific studies – other studies suggest greater benefit – a range (2-5/1000) may be better.
  3. The use of the word “many” in the context of over-diagnosis & overtreatment is pejorative, and not reflective of the uncertainty surrounding these concepts – “some” would be better
  4. No account is taken of recent changes in practice which impact quoted figures:
    1. Changes in biopsy technique, use of anaesthesia and analgesia to mitigate discomfort, increasing use of trans-perineal route
    2. Increased application of active surveillance (~40% of low-risk men in Victorian data from the Prostate Cancer Registry) to minimise treatment-related harm – invalidates the quoted figures for treatment side-effects
4. What research has been done to study the effectiveness of PSA testing for prostate cancer?: 

Restricting the analysis of evidence to randomised controlled trials (RCTs) only does not allow an adequate assessment of the impact of PSA testing on prostate cancer outcomes. The RCTs are heterogeneous, and suffer from significant shortcomings in design that make them less likely to detect a true impact.

The RCTs also focus on population-wide screening, which is distinct from the current approach in Australia, which is usually opportunistic.

There are additional sources of evidence, especially from epidemiological studies which suggest diminishing rates of prostate cancer mortality resulting from PSA testing.

5. Does PSA testing in asymptomatic men reduce their risk of dying from prostate cancer?: 

The most reliable data on prostate cancer mortality derive from the ERSPC and Goteborg trials, with other trials being too small or methodologically flawed.

Additional data from epidemiological studies (see above) that has not been considered.

6. Does PSA testing in asymptomatic men reduce their overall risk of dying?: 

Overall survival is a less meaningful endpoint than cancer specific survival in the screening studies. Certainly the power to detect any impact on overall survival was limited, and in the older population that is at risk for prostate cancer, death from competing causes is common.

7. Does PSA testing in asymptomatic men reduce their risk of having metastases present at diagnosis of prostate cancer?: 

This is a very important endpoint for PSA testing, since even if men do not die from their prostate cancer, if they develop metastatic disease and need androgen deprivation therapy, this causes significant suffering and impact on quality of life.

8. Does PSA testing in asymptomatic men affect the quality of life of men who are diagnosed with prostate cancer?: 

This section is misleading - PSA testing does impact the quality of life of men diagnosed with prostate cancer, by reducing the risk of metastatic disease and consequent androgen deprivation therapy.

10. How accurate is a PSA test?: 

The “accuracy” of the PSA test is variable, depending on factors such as patient age, family history, degree and rate of elevation, DRE findings etc. The overall figure of 7/10 is potentially misleading without taking the above into account.

Currently, additional measures such as PSA kinetics and isoforms, as well as new biomarkers and imaging findings are being assessed in an effort to improve the selection of men for prostate biopsy.

Again the use of the word “many” in the context of “slow-growing” cancers is pejorative, and would be better to replace with “some” – the future behaviour of a particular man’s prostate cancer is often not predictable at the time of diagnosis, and the proportion of so-called “insignificant” or non life-threatening cancers varies depending on a range of factors such as PSA level, DRE findings, age, family history etc.

11. Are there any other screening tests available for prostate cancer?: 

It is important to stress that DRE should be performed along with PSA-testing, since a proportion of prostate cancers may present with a normal PSA but abnormal findings on DRE.

13. What are normal and abnormal PSA test results?: 

The impact of pharmacological treatment with 5-alpha reductase inhibitors on lowering PSA levels (approximately 50%) is worth including

The importance of age-specific reference ranges needs to be stressed – younger men with relatively modest PSA levels may be at greater risk of serious prostate cancer.

15. What happens if a man receives an abnormal PSA test result?: 

The information presented regarding prostate biopsy over-emphasises the negative impact of biopsies. While it is reasonable to list them, it is important to point out:

  1. False negative rates from current biopsy approaches are low, around 5-10%.
  2. Most adverse effects of biopsies are mild and self-limited, serious complications are rare.
16. If a man receives a diagnosis of prostate cancer after an abnormal PSA test, what choices does he have?: 

The summary of treatment options comes across as confusing. Watchful waiting and active surveillance are different in their intent, and applied to different patient populations. The terms have not been defined, and the differences are not necessarily clear to all GPS. Curative local treatment usually entails either radical prostatectomy or radiotherapy. Androgen deprivation therapy is usually a palliative treatment for patients with metastatic disease.

The side-effects of treatments are characterised as being “common” – although they vary significantly depending on many factors. It would be more appropriate to state “known side-effects”.

It is worth pointing out the utility of PSA testing in monitoring men with a known diagnosis of prostate cancer, during and after treatment.

17. If a man decides not to have a PSA test what risks should he and his family be aware of?: 

“In the unlikely event that prostate cancer is present” – makes the unwarranted presupposition that the man has a low risk of prostate cancer – better replaced with “If prostate cancer is present”

General Comments
18. Considering the Information Document is for Health Practitioners, do you have any other comments?: 

There are several decision aids in use for men contemplating PSA testing. This document tries to use some of the points of these without using the whole validated aid; and does not reference any of the aids. It should contain direct links to the validated decision aids.

 The fact that this document refers to PSA testing in asymptomatic men needs to be made clearer – e.g. by inclusion in the first box on p1.

There is a need for a consistent consensus between all specialities/organisations - RACGP, RACS, AUA, CCV and similar organisations. For GPs/providers on the ground and patients, there is much confusion which is not helped by media and divergent views from experts.

We would encourage and support a streamlined guideline reflecting the complex aspects of PSA screening to be developed.

Given the continuing high level research in this area, the changing landscape of risk stratification and active surveillance in PSA screening, it is likely that a more nuanced strategy will better assist in care of patients with prostate cancer. 

 We would also suggest keeping in mind the following caveats:

  • Prostate cancer remains a common condition, and as such continues to cause a large number of deaths. Currently, PSA testing and early detection provides the main means of preventing these deaths.
  • Prostate cancer also causes significant symptoms and complications in many men even when it is not fatal for them – the focus on death can be misleading because prostate cancer occurs in older men, who have competing causes of death. Published trials clearly show that PSA testing reduces the occurrence of metastatic prostate cancer.
  • Some men are at a higher risk of developing and dying from prostate cancer (e.g. those with a family history of prostate cancer) – if they are discouraged from PSA testing, they may miss a critical opportunity for early detection and treatment.
  • The guidelines refer to asymptomatic men only, and it should be remembered that PSA testing has a well-defined role in the assessment of men with urinary symptoms. 

Page reviewed: 4 March, 2014