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

ID: 
8
This submission reflects the views of
Organisation Name: 
Prostate Cancer Foundation of Australia
Please identify the best term to describe the Organisation: 
Consumer organisation
Personal Details
Specific Questions
1. What are the potential benefits of PSA testing?: 

PSA testing has been shown to result in diagnosis of prostate cancer at an earlier stage and grade of disease.  Specifically, ERSPC showed a reduction of up to 30% in the risk of having metastatic disease present at diagnosis.  Once metastasis has occurred curative treatment is no longer possible.  Further, the primary treatment for advanced disease -androgen deprivation therapy - has a significant adverse effect on quality of life, typically over many years, and is costly relative to treatment for localised disease.  Hence, the benefits of early detection and treatment and consequent avoidance of advanced disease should be noted as a potential benefit of PSA testing.

2. What are the potential harms of PSA testing?: 

Prostate cancer diagnosis should be uncoupled from prostate cancer intervention.  It is incorrect to assume that radical intervention automatically follows diagnosis.  Many men with low risk prostate cancer do not require radical treatment.  Active surveillance protocols have been shown to be a reasonable and safe option for men with low volume, low risk prostate cancer.  Currently some 40% of newly diagnosed, low risk men in Victoria undergo active surveillance rather than radical treatment.  Hence, whilst PSA testing is known to result in over diagnosis it does not of itself lead to over treatment.

3. How frequent are these benefits and harms?: 

In this section the variation with age and familial risk should be quantified to enable informed decision making.  PCFA’s 2013 Community Attitudes Survey reveals that men are being tested from their early twenties onwards even though less than 3% of prostate cancer diagnoses occur in men under age 50.  This section should therefore explain that:

  • Incidence rises steeply from age 45 to 70
  • There is a 1 in 7 risk of being diagnosed by age 75 and a 1 in 5 risk of being diagnosed by age 85
  • Men who have a father or brother who has been diagnosed with prostate cancer are at twice the risk of developing the disease as men with no relatives affected
  • There is a trend of increasing risk with increasing number of affected family members such that men with two or three first degree relatives affected have a five and eleven fold increased risk of developing the disease.

The reduced risk of having metastatic disease present at diagnosis should be quantified and mentioned as a benefit of PSA testing.

Prostate cancer diagnosis should be uncoupled from prostate cancer intervention (see 2 above).

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

The statement “one trial found that PSA testing does lead to a small reduction in death from prostate cancer” is misleading.  ERSPC found a 21% reduction in the core age group and Goteborg found a 44% reduction.  These are significant reductions in prostate cancer specific mortality.  We acknowledge that PLCO found no reduction and that the conclusion that the present evidence is inconclusive is correct.  Phrasing such as “Of the two largest trials, one found that PSA testing does lead to at least a 20% reduction in death from prostate cancer, whereas the other found that PSA testing does not reduce death from prostate cancer.  Thus, the present evidence is inconsistent as to whether there is an effect of PSA testing on the risk of dying from prostate cancer.” would be a more accurate statement of the present evidence.

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

The conclusion in this section that the evidence shows that PSA testing reduces the risk of having metastases present at diagnosis of prostate cancer is important and should be included as a potential benefit of PSA testing

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

It is unclear what the reader is expected to infer from the statement “It is unknown if PSA testing affects quality of life due to advanced prostate cancer.”  It is known that PSA testing reduces the risk of having metastases present at diagnosis of prostate cancer and that the primary treatment for advanced disease - androgen deprivation therapy - has a significant adverse effect on quality of life, typically over many years.

10. How accurate is a PSA test?: 

The use of the word “screening” in the first sentence is unhelpful because of the possible confusion with population based screening.  Phrasing such as “A PSA test is only able to detect possible prostate health issues – it cannot be used to diagnose prostate cancer.” would be preferable.

The statement “For most men, PSA testing cannot accurately determine which cancers are likely to threaten his health and which will not.” is misleading and should be removed.  As noted earlier in the same section, PSA testing cannot be used to diagnose prostate cancer, let alone distinguish between indolent and aggressive disease.

This section should also describe in brief the Gleason system used following prostate biopsy to grade the cancer and evaluate the prognosis.  It should also describe the staging system for prostate cancer. 

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

This section should note that PSA testing in combination with DRE is currently the best available approach.  Other tests such as Prostate Health Index (PHI), PCA3 and multi-parametric magnetic resonance imaging remain to be established.

12. How can men prepare for a PSA test?: 

Mention should be made that a PSA test with or without a DRE would normally be conducted as part of a routine health check and that, given the limited time available to GPs to assist in informed decision making, men can prepare themselves by informing themselves about the potential benefits and potential harms of testing and subsequent treatment for prostate cancer.  Consideration needs to be given to strategies to assist men make an informed decision.

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

Anecdotal evidence indicates that many health practitioners are not aware of what represents an abnormal PSA result that would warrant referral to a specialist.  We therefore recommend that the age specific reference ranges are included here for the benefit of health practitioners.

Oesterling et al (Serum prostate specific antigen in a community-based population of healthy men: Establishment of age-specific reference ranges. JAMA 1993;270:860-4 ) gives the following recommended reference ranges for serum PSA (95th percentile):

  • 40 to 49 years:  0.0 to 2.5 ng/mL
  • 50 to 59 years:  0.0 to 3.5 ng/mL
  • 60 to 69 years:  0.0 to 4.5 ng/mL
  • 70 to 79 years:  0.0 to 6.5 ng/mL

The commonly quoted figure of 4.0 ng/mL is quite arbitrary and has little validity on its own.

14. What happens if a man receives a normal PSA test result?: 

We recommend that specific guidance is included on what constitutes a normal/ abnormal PSA test result (see 11 above).  The absence of such information risks inconsistencies in clinical practice.  Anecdotal evidence indicates some men with very high PSA levels are not referred to a specialist for further investigation.  The absence of such guidance may result in late referral for men who are at risk having advanced disease, and potentially poorer outcome at definitive diagnosis.

The PCFA-CCA clinical guidelines (see 18 below) will address this issue.

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

See comments in 14 above.

16. If a man receives a diagnosis of prostate cancer after an abnormal PSA test, what choices does he have?: 

This section reads as though the terms watchful waiting (an approach to management of disease in older men with limited life expectancy under which the specialist will recommend treatment with palliative intent if the disease progresses) and active surveillance (a strictly defined protocol for monitoring low volume, low risk prostate cancer under which the specialist will recommend treatment with curative intent if the disease progresses) are synonymous, which they are not.  Active surveillance involves repeat serum PSA measurements/ DREs and repeat visits to a specialist.  Repeat biopsies are taken typically 2 to 3 years apart.  This approach reduces exposure to radical treatment.  Currently some 40% of newly diagnosed, low risk men in Victoria undergo active surveillance rather than radical treatment. 

This section reads as though radical prostatectomy, radiation therapy and androgen deprivation therapy are alternative treatment modalities applicable in every situation, which they are not.  It also does not refer to the various different types of radiation therapy e.g. 3D conformal external beam, IMRT with fiducials and brachytherapy.

It would be helpful to describe in broad terms how the Gleason score aids in choosing appropriate treatment options i.e. low grade Gleason 6 cancers, which are the most commonly diagnosed, are generally suitable for active surveillance or watchful waiting.  Intermediate Gleason 7 cancers are sometimes suitable for active surveillance, or watchful waiting in men greater than 75 years old, but are also suitable for radical treatment in younger men.  High grade Gleason 8+ cancers always require radical treatment (if possible) either with or without androgen ablation or androgen ablation alone.

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

The statement “The cancer may not be diagnosed and treated until it causes symptoms, by which time it may have spread beyond the prostate and may be harder to manage.” is misleading in that advanced disease is incurable, not just harder to manage.  Phrasing such as “The cancer may not be diagnosed and treated until it causes symptoms, by which time it is likely to have spread beyond the prostate.  Once the cancer has spread well beyond the prostate, although treatment is possible it cannot be cured.” would be more accurate.

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

We recommend that a statement that parallel to NHMRC’s work on PSA testing, Prostate Cancer Foundation of Australia (PCFA) and Cancer Council Australia (CCA) are jointly developing evidence-based clinical practice guidelines.  These guidelines will supplement NHMRC’s work by providing further clinical guidance for doctors consulting with men about having a PSA test.  The guidelines will be developed using the NHMRC procedures and requirements to meet the 2011 NHMRC standard for clinical practice guidelines (the 2011 NHMRC Standard). The guidelines are due to be finalised in late 2014.

It should be noted that PSA is an extremely useful tumour marker in advanced disease allowing staging, monitoring response to treatments and prognostic information all of which benefit patient care.

As noted in the evidence reports there is limited level 1 evidence to guide the development of this statement and the clinical guidelines.  Hence, we recommend the inclusion of other evidence, which whilst less conclusive, is nevertheless potentially informative in developing guidance for health practitioners.

Page reviewed: 4 March, 2014