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Published: 2015
National Health and Medical Research Council 
These guidelines (recommendations) in the web-version of this guideline were approved by the Chief Executive Officer of the National Health and Medical Research Council (NHMRC) on 2 November 2015 under section 14A of the National Health and Medical Research Council Act 1992 In approving the guidelines (recommendations), NHMRC considers that they meet the NHMRC standard for clinical practice guidelines. This approval is valid for a period of five years. NHMRC is satisfied that the guidelines (recommendations) are systematically derived, based on the identification and synthesis of the best available scientific evidence, and developed for health professionals practising in an Australian health care setting.
This publication reflects the views of the authors and not necessarily the views of the Australian Government.The guidelines have been produced by a process of systematic literature review; critical appraisal and consultation encompassing all interested parties in Australia (see Appendix 1).
This guideline includes evidence-based recommendations (EBR), consensus-based recommendations (CBR) and practice points (PP) as defined in Table 4. Recommendations and practice points were developed by working party members and sub-committee members.
Each EBR was assigned a grade by the expert working group, taking into account the volume, consistency, generalisability, applicability and clinical impact of the body of evidence supporting each recommendation – see Table 2.
Information about levels of evidence can be found in the Evidence Summaries for each recommendation in each chapter.
Recommendations
Risk
The question does not lead to a recommendation.
Testing
PSA Testing strategies
| Recommendation | Grade |
|---|---|
 For men at average risk of prostate cancer who have been informed of the benefits and harms of testing and who decide to undergo regular testing for prostate cancer, offer PSA testing every 2 years from age 50 to age 69, and offer further investigation if total PSA is greater than 3.0 ng/mL.
|
C |
| Consensus-based recommendation(s) |
|---|
 If the necessary data become available and the required processes put in place to ensure effective implementation, consider replacing > 3.0 ng/mL with > 95th percentile for age as the criterion for further investigation.
|
| Do not offer PSA testing at age 40 years to predict risk of prostate cancer death.
|
| For men younger than 50 years who are concerned about their risk for prostate cancer, have been informed of the benefits and harms of testing, and who wish to undergo regular testing for prostate cancer, offer testing every 2 years from age 45 to age 69 years.
If initial PSA is at or below the 75th percentile for age, advise no further testing until age 50. If initial PSA is above the 75th percentile for age, but at or below the 95th percentile for age, reconfirm the offer of testing every 2 years. If a PSA test result before age 50 years is greater than the 95th percentile for age, offer further investigation. Offer testing from age 50 years according to the protocol for all other men who are at average risk of prostate cancer. |
| Advise men 70 years or older who have been informed of the benefits and harms of testing and who wish to start or continue regular testing that the harms of PSA testing may be greater than the benefits of testing in men of their age.iii
iii This Consensus-based recommendation assumes testing with the criterion for further investigation a PSA of ≥ 3 ng/mL. This recommendation will be a high priority for reconsideration when the Australian model of PSA testing has been completed. For example, use of the 95th percentile for age in place of ≥ 3 ng/mL might improve appreciably the balance of harms to benefits of testing in men 70–74 years of age. |
| For men whose risk of prostate cancer is estimated to be at least 2.5–3 times higher than average due to the presence of risk factors (e.g. a brother diagnosed with prostate cancer, particularly if younger than 60 years at diagnosis), and who decide to undergo testing after being informed of the benefits and harms, offer testing every 2 years from age 45–69 years.
For men whose risk of prostate cancer is estimated to be at least 9–10 times higher than average due to the presence of risk factors (e.g. father and two brothers diagnosed with prostate cancer), and who decide to undergo testing after being informed of the benefits and harms, offer testing every 2 years from age 40–69 years. If initial PSA is at or below the 75th percentile for age, advise no further testing until age 50. If initial PSA is above the 75th percentile for age, but at or below the 95th percentile for age, reconfirm the offer of testing every 2 years. If a PSA test result before age 50 years is greater than 95th percentile for age, offer further investigation. Offer testing from age 50 years according to the protocol for men who are at average risk of prostate cancer. |
Role of digital rectal examination
| Recommendation | Grade |
|---|---|
| In asymptomatic men interested in undergoing testing for early diagnosis of prostate cancer, digital rectal examination is not recommended as a routine addition to PSA testing in the primary care setting.
|
C |
| Practice point(s) |
|---|
| Although DRE is not recommended as a routine test for men who, after advice, wish to be tested for the presence of prostate cancer, it will still be an important part of the man's assessment on referral to a urologist or other specialist for further assessment prior to consideration for biopsy.
|
PSA testing and life expectancy
| Recommendation | Grade |
|---|---|
| Since any mortality benefit from early diagnosis of prostate cancer due to PSA testing is not seen within less than 6–7 years from testing, PSA testing is not recommended for men who are unlikely to live another 7 years.
|
C |
| Practice point(s) |
|---|
When discussing the benefits and harms of PSA testing with older men or those with a potentially fatal chronic illness, explain each of the following:
|
| The percentage of men of a given age, and average health status for their age who are expected to live for another 7 years is as shown in the table below.
|
(The table is provided at the bottom of this page)
Testing with variants of PSA to improve sensitivity after an initial total PSA ≤ 3.0 ng/mL
| Recommendation | Grade |
|---|---|
| For men aged 45–69 years whose risk of prostate cancer is at least double the average risk and with total PSA 2.0–3.0 ng/mL, consider offering prostate biopsy if free-to-total PSA is less than 25%.
|
D |
| Consensus-based recommendation(s) |
|---|
| Do not use PSA velocity or the PHI test as adjuncts to total PSA testing in determining whether or not to offer prostate biopsy, except in the context of research conducted to assess their utility for this purpose.
|
Testing with variants of PSA or repeat PSA testing to improve specificity after an initial total PSA > 3.0 ng/mL
| Recommendation | Grade |
|---|---|
| For men aged 50–69 years with initial total PSA greater than 3.0 ng/mL, offer repeat PSA within 1–3 months.
For those with initial total PSA greater than 3.0 ng/mL and up to 5.5 ng/mL, measure free-to-total PSA percentage at the same time as repeating the total PSA. |
D |
| Measurement of PSA velocity is not recommended to increase specificity of a total PSA test result of 3.0 ng/mL or greater.
|
D |
| Consensus-based recommendation(s) |
|---|
For men aged 50–69 years with initial total PSA greater than 3.0 ng/mL who have undergone repeat total PSA and free-to-total PSA percentage tests at follow-up 1–3 months later, offer prostate biopsy:
|
| For men aged 50–69 years with a previous total PSA test result greater than 3.0 ng/mL who are not offered prostate biopsy (or do not accept prostate biopsy when offered) after follow-up PSA testing, explain that there is a small chance of missing a significant cancer and advise them to return for PSA testing within 2 years.
|
| Do not use the PHI test to increase specificity of a total PSA test result of 3.0 ng/mL or greater, except in the context of research conducted to assess its utility for this purpose.
|
Decision support for men considering PSA testing
| Recommendation | Grade |
|---|---|
| Offer evidence-based decisional support to men considering whether or not to have a PSA test, including the opportunity to discuss the benefits and harms of PSA testing before making the decision.
|
C |
| Practice point(s) |
|---|
| Familiarity with the NHMRC fact sheet PSA testing for prostate cancer in asymptomatic men. Information for health practitioners, which summarises evidence on the benefits and harms of PSA testing, should help health practitioners to accurately inform men about PSA testing.
|
Prostate biopsy and multiparametric MRI
Biopsy quality criteria
| Recommendation | Grade |
|---|---|
| Take 21–24 cores in initial biopsies for the diagnosis of prostate cancer. In addition to the sextant biopsies, direct 15–18 additional biopsies to the peripheral zones of the prostate.
|
B |
| Practice point(s) |
|---|
| Before offering biopsy after an elevated total PSA test result, take into account a man’s family history of prostate cancer (see Chapter 1 Risk) and the results of further investigations (see 2.5 Testing with variants of PSA to improve sensitivity after an initial total PSA ≤ 3.0 ng/mL and 2.6 Testing with variants of PSA or repeat PSA testing to improve specificity after an initial total PSA > 3.0 ng/mL).
|
| Transrectal and transperineal biopsy approaches are both acceptable with respect to rates of cancer detection. The approach taken should be based on the man’s wishes, the surgeon’s experience, risk of sepsis and other morbidity, and practical issues such as cost and access to the necessary facilities.
|
Follow-up to a negative prostate biopsy
| Recommendation | Grade |
|---|---|
| Advise men whose initial biopsy is negative for prostate cancer that they should continue to be followed.
Monitor more closely men with abnormal findings on pre-biopsy digital rectal examination, and those whose biopsy findings included either atypical small acinar proliferation or high-grade prostatic intra-epithelial neoplasia. In addition to further PSA testing and digital rectal examination, consider prostate imaging with investigations that can help to localise the site of cancer within the prostate, and repeat biopsy using a targeted approach. |
D |
| Consider multiparametric MRI (using T2- and diffusion-weighted imaging) for men with a negative transrectal ultrasound-guided biopsy to determine whether another biopsy is needed.
Do not offer another biopsy if the multiparametric MRI (using T2- and diffusion-weighted imaging) is negative, unless any of the following risk factors are present:
|
D |
| Practice point(s) |
|---|
| Multiparametric MRI should be used only in centres with experienced radiologists appropriately trained in the use of multiparametric MRI to aid urologists in the management of individual patients.iv
iv Refer to Urological Society of Australasia position statement: Status of mp-MRI prostate 2012: report from the MRI Prostate Working Party (available at www.usanz.org.au). |
| Clinicians and other staff performing multiparametric MRI should do so in accordance with appropriate standards and guidelines for its use.v
v See Moore CM, Kasivisvanathan V, Eggener S, et al. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. European urology 2013; 64: 544-552. |
| The recommendations for multiparametric MRI apply only to its use in patients who have already undergone biopsy. Primary healthcare professionals should not order multiparametric MRI in the initial investigation of suspected prostate cancer in men with raised PSA levels.
|
| Advise patients not undergoing repeat biopsy after a normal multiparametric MRI that there is a 10–15% chance of missing a significant cancer and that further follow-up is recommended.
|
| For men at average risk for prostate cancer whose initial biopsy is negative for prostate cancer, and who have a life expectancy of less than 7 years (e.g. due to their age or due to other illness), advise that no further action is recommended unless they develop symptoms that suggest prostate cancer.
|
Active surveillance and watchful waiting
Active surveillance
| Recommendation | Grade |
|---|---|
Offer active surveillance to men with prostate cancer if all the following criteria are met:
|
C |
| Practice point(s) |
|---|
| Advise men with low-risk prostate cancer that, if they choose active surveillance, their risk of death due to prostate cancer over the next 10 years would be low, and would probably be no greater than if they were to choose immediate definitive treatment.
|
| When considering active surveillance, take into account other factors that may be associated with risk of future pathological progression but for which evidence is inconsistent (e.g. total cancer length at biopsy, tumour volume, PSA doubling time < 3 years and PSA density).
|
| In centres where staff have skills and experience in the use of multiparametric MRI for prostate examination, consider using it to help identify foci of potentially higher-grade disease, aid targeting at reclassification biopsies and aid determination of interval tumour growth. Clinicians and other staff performing multiparametric MRI should refer to appropriate standards and guidelines for its use (Moore CM et al 2013).
|
| Consensus-based recommendation(s) |
|---|
Consider offering active surveillance to men with prostate cancer if all the following criteria are met:
For men aged less than 60 years, consider offering active surveillance based on the above criteria, provided that the man understands that treatment in these circumstances may be delayed rather than avoided. |
Consider offering definitive treatment for:
If the man strongly prefers active surveillance, offer repeat biopsy to ensure that disease classification is accurate. |
Consider offering definitive treatment to men aged less than 60 years with either of the following:
If the man strongly prefers active surveillance, offer repeat biopsy. |
| For men with prostate cancer managed by an active surveillance protocol, offer monitoring with PSA measurements every 3 months, and a physical examination, including digital rectal examination, every 6 months.
|
| Offer a reclassification repeat prostate biopsy within 6–12 months of starting an active surveillance protocol.
Offer repeat biopsies every 2–3 years, or earlier as needed to investigate suspected disease progression: offer repeat biopsy and/or multiparametric MRI (in specialised centres) if PSA doubling time is less than 2–3 years or clinical progression is detected on digital rectal examination. |
| During active surveillance, offer definitive treatment if pathological progression is detected on biopsy, or if the patient prefers to proceed to intervention.
|
Watchful waiting
| Recommendation | Grade |
|---|---|
For men with potentially curable prostate cancer who are considering watchful waiting, advise that:
|
C |
| Practice point(s) |
|---|
For men whose prostate cancer is advanced and is not curable with local treatments, follow guidelines for the management of locally advanced or metastatic prostate cancer. If no treatment is offered or accepted, monitor clinically and by PSA testing and reconsider androgen deprivation therapy if any of the following occur:
|
| Consensus-based recommendation(s) |
|---|
| Offer watchful waiting to men diagnosed with potentially curable prostate cancer who, for reasons other than prostate cancer, are unlikely to live for more than another 7 years.
|
| Offer watchful waiting to men diagnosed with potentially curable prostate cancer who choose not to accept potentially curative therapy when it is offered to them.
|
| For all men choosing watchful waiting, discuss the purpose, duration, frequency and location of follow-up with the man and, if he wishes, with his partner or carers.
Source: adapted from [UK] National Collaborating Centre for Cancer. Prostate cancer: diagnosis and treatment. National Collaborating Centre for Cancer; 2014. |
| Specialists should consider referring men without advanced incurable prostate cancer back to their general practitioners for follow-up in primary care according to a protocol the specialist suggests and/or these guidelines.
If there is no evidence of significant disease progression (as indicated by 3–4 monthly PSA levels over 1 year and absence of relevant symptoms), continue monitoring by 6-monthly PSA levels. If there is evidence of significant disease progression (that is, relevant symptoms and/or rapidly-rising PSA level), refer to a member of the treating team (urologist, medical oncologist or radiation oncologist) for review. |
PSA testing and life expectancy
| Age | Percentage of men remaining alive after 7 years |
| 50 | 97% |
| 55 | 96% |
| 60 | 94% |
| 65 | 91% |
| 70 | 85% |
| 75 | 74% |
| 80 | 57% |
| 85 | 37% |
| 90 | 19% |
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