This resource has been developed, reviewed or revised more than five years ago. It may no longer reflect current evidence or best practice.
For explanation of levels of evidence and grades for recommendations, see Levels of evidence and grades for recommendations below. You may also like to refer to the Appendix - Guideline development process
Psychosocial care
| Recommendation
|
Grade
|
 Men with advanced prostate cancer should be offered education about their cancer, treatment options, and the benefits and disadvantages of available approaches, as well as strategies to manage treatment side effects at each stage in the progression of prostate cancer. A range of formats including written information, verbal instruction and multimedia could be considered.
|
C
|
| Recommendation
|
Grade
|
| Men with advanced prostate cancer should be offered psychosocial interventions to enhance their adjustment.
Effective approaches include group-based cognitive behavioural interventions, nurse delivered education and support, sensory patient education, one-to-one peer support and group education and discussion (support groups).
However, psychosocial intervention research for prostate cancer has predominantly been undertaken with men with localised disease. Research addressing the unique psychosocial needs of men with advanced disease is needed.
|
B
|
| Recommendation
|
Grade
|
| Men with advanced prostate cancer should be advised that resistance exercise and moderate to strenuous physical activity with expert supervision/support can improve quality of life and muscular fitness and reduce fatigue and the impact of fatigue on daily living. Unstable bone lesions and co-morbidities such as cardiovascular disease are exclusion criteria for studies on this topic and so are likely contraindications for this approach.
|
D
|
| Recommendation
|
Grade
|
| No recommendations are able to be made about effective ways to improve sexual
adjustment in men with advanced prostate cancer and their female or male partners. Research into effective interventions for men with advanced prostate cancer is needed.
|
D
|
| Recommendation
|
Grade
|
| As yet there is insufficient evidence to strongly recommend a specific approach to reducing psychological distress and improving quality of life for the partners of men with advanced prostate cancer. However, group psycho-education may be of benefit. Research into effective interventions for the partners of men with advanced prostate cancer is urgently needed.
|
D
|
| Recommendation
|
Grade
|
| Health professionals should be aware of risk factors for the development of anxiety and
depression and be prepared to treat appropriately.
|
B
|
Locally advanced disease
Androgen deprivation therapy (ADT)
| Recommendation
|
Grade
|
| No strong recommendation can be made for the use of androgen deprivation therapy in locally advanced disease. However, there may be a modest benefit for immediate or primary androgen deprivation therapy for patients with locally advanced disease deemed not suitable for definitive local therapy. However, this has to be weighed against the impact of androgen deprivation therapy on quality of life.
|
C
|
| Recommendation
|
Grade
|
| A recommendation cannot be made on the basis of the evidence currently available.
|
D
|
| Recommendation
|
Grade
|
It is recommended that the prescriber take into account the following points when commencing ADT:
- The use of non-steroidal anti-androgens as monotherapy may have fewer and less severe adverse events than medical or surgical castration but may still have a toxicity profile that impairs quality of life, and there is little to no efficacy data to support their use as monotherapy.
- Extrapolating from evidence with metastatic disease (see Overt metastatic disease and/or loco-regional progressive disease), Combined androgen blockade (CAB) with an antiandrogen does increase the adverse event profile versus medical or surgical castration monotherapy and this needs to be weighed up against its marginal additional survival benefits seen in patients with metastatic disease.
- When the unwanted effects of treatment are preferable to the unwanted effects of the tumour (e.g. prevent recurrence with increased overall survival in adjuvant setting), the side-effect profiles of the treatment options should be explained and strategies to minimise these effects should be considered with the patient.
|
B
|
| Recommendation
|
Grade
|
| Before commencing patients on androgen deprivation therapy, consider the likely duration of that treatment and the risk–benefit analysis for the indication for treatment, and take into account the effects on bone mineral density and risks of pathological fractures from osteoporosis.
|
C
|
| Recommendation
|
Grade
|
| Toxicities should be considered in the context of what is important to each individual patient, as for some patients impairment of sexual function may have a significant impact on their quality of life and overall adjustment, as well as affecting adversely those close to them.
|
C
|
Radiotherapy
| Recommendation
|
Grade
|
| When radiation therapy alone is used, limited field radiotherapy has similar efficacy and has less toxicity than whole pelvis and therefore is recommended. The role of whole pelvis radiation is yet to be defined.
Consideration should be given to dose escalation (74Gy or higher) if it can be delivered
safely.
Patients with locally advanced prostate cancer should receive 3D conformal radiation to minimise toxicity.
|
C
|
| Recommendation
|
Grade
|
| Based on randomised trial evidence, it is not possible to quantify the degree of benefit
provided by radiotherapy alone for locally advanced prostate cancer. The role of surgery or hormonal therapy alone in this group of patients remains to be defined.
|
D
|
| Radiation in addition to hormone therapy improves survival and is recommended.
|
B
|
| Recommendation
|
Grade
|
| 3D conformal dose escalated external beam radiotherapy alone, or reduced dose external beam radiation treatment in combination with high dose-rate brachytherapy, are well recognised radical treatments for locally advanced disease. There is no randomised evidence to suggest superiority or to recommend one modality over the other.
|
D
|
Radiotherapy and androgen deprivation therapy (ADT)
| Recommendation
|
Grade
|
| Androgen deprivation therapy can be used in combination with radiotherapy without additional radiotherapy toxicities (urinary and gastrointestinal). Effect on sexual functioning has not been defined.
|
C
|
Surgery
| Recommendation
|
Grade
|
| There is insufficient evidence to support the use of surgery in the management of advanced prostate cancer, with the possible exception of a transurethral resection of the prostate in men who are unable to void after androgen deprivation therapy.
|
C
|
Surgery plus androgen deprivation therapy
| Recommendation
|
Grade
|
| For locally advanced prostate cancer, anti-androgens as an adjuvant monotherapy to radical prostatectomy are not recommended.
|
B
|
| For node-positive disease androgen deprivation therapy (ADT) should be considered. For patients with fully resected node-positive disease (prostatectomy and lymphadenectomy), it is strongly recommended that patients be counselled on the overall survival benefit of ADT and weighed against the short- and long-term toxicities of androgen deprivation. It is further recommended that patients be counselled on the 'benefit’ of improved survival in relation to the ‘risk’ of therapy – namely the impact of ADT on quality of life.
|
C
|
| Recommendation
|
Grade
|
| It is recommended that patients with extracapsular extension, seminal vesicle involvement or positive surgical margins receive post-operative EBRT within four months of surgery. The role of active surveillance and early salvage radiotherapy has not been defined.
|
B
|
Node-positive disease
| Recommendation
|
Grade
|
| If radical radiotherapy is given to patients with node-positive disease it is reasonable to offer long-term androgen deprivation in addition to radiotherapy.
|
D
|
| Recommendation
|
Grade
|
| There is insufficient evidence to make a recommendation for the use of external beam
radiation as alternative or adjuvant to hormone therapies in node-positive patients.
|
|
Biochemical relapse
| Recommendation
|
Grade
|
| The optimal timing of androgen deprivation therapy in patients with biochemical relapse of disease without evidence of overt metastatic disease is not defined. Eligible patients should be informed about the current TROG Trial comparing early versus delayed hormonal therapy in this group.
|
|
Overt metastatic disease and/or loco-regional progressive disease
Castration-resistant prostate cancer
Androgen deprivation therapy
| Recommendation
|
Grade
|
| There is a sequence of actions that should be followed when a patient is shown to have progressive cancer on androgen deprivation therapy.
First, confirm that the patient has a castrate level of testosterone if on an LHRH agonist therapy. If the patient is also on a nonsteroidal anti-androgen, this agent could be withdrawn and observed for the possibility of an anti-androgen withdrawal phenomenon.
It is reasonable to trial further hormone manipulations if the patient is asymptomatic or minimally symptomatic prior to use of chemotherapy (e.g. docetaxel).
|
C
|
| Recommendation
|
Grade
|
| There is insufficient evidence to make a recommendation as to whether a patient should continue LHRH agonist therapy once his disease has progressed while on androgen deprivation.
|
D
|
Bisphosphonates
| Recommendation
|
Grade
|
| Zoledronic acid should be considered for the prevention of skeletal related events in men with asymptomatic or mildly symptomatic hormone resistant/castrate resistant metastatic prostate cancer.
Men as part of the informed consent process should be made aware that nine men will need to be treated for one to achieve a benefit and that there is a 5% risk of osteonecrosis of the jaw occurring during treatment.
Renal function needs to be monitored during treatment. Ideally treatment should be confined to men whose serum creatinine is less than 265umol/L at the time of starting treatment.
|
B
|
| Recommendation
|
Grade
|
| On the basis of the available evidence, bisphosphonates are not recommended for routine palliation of symptomatic bone disease in men, with hormone-resistant prostate cancer with a possible exception of zoledronic acid, where there is some evidence of a benefit in castrate-resistant men.
|
C
|
Chemotherapy
| Recommendation
|
Grade
|
| The combination of mitoxantrone and prednisolone also offers palliative benefit but no survival benefit compared to docetaxel.
|
C
|
| Docetaxel in combination with prednisone is appropriate in the first line setting to improve survival, pain and quality of life in good performance patients with castrate-resistant metastatic prostate cancer.
|
B
|
Palliative care
| Recommendation
|
Grade
|
| Men with metastatic prostate cancer should be referred for specialist palliative care or a coordinated palliative approach to assist in advance care planning.
|
C
|
| Recommendation
|
Grade
|
| Men with metastatic prostate cancer should be referred for interdisciplinary palliative care to assist in symptom control and in providing emotional, social and spiritual support.
|
C
|
| Recommendation
|
Grade
|
| Men with metastatic prostate cancer and their families should be referred for a coordinated palliative approach to assist in providing effective end-of-life care.
|
C
|
Complementary and alternative therapies
| Recommendation
|
Grade
|
| Health professionals should ask their patients about their use of CAM therapies in a supportive, understanding and non-judgmental way.
|
D
|
| Calcitriol in combination with docetaxel chemotherapy is not recommended on the basis of a large randomised trial which found excess mortality.
|
A
|
| Lycopene may benefit a small group of men with metastatic prostate cancer who have had no radiotherapy, no hormone therapy and who have had orchidectomy. In view of these findings, lycopene deserves to be further trialled.
|
C
|
| There is insufficient evidence to make any recommendations on dietary supplements in relation to quality of life, pain relief and toxicity.
|
C
|
Socio-economic aspects of advanced prostate cancer
| Recommendation
|
Grade
|
| Based on a lack of evidence from randomised trials or observational studies, it is not possible to determine whether socio-economic status is associated with differences in outcomes for men with locally advanced or metastatic prostate cancer.
|
D
|
Levels of evidence and grades for recommendations
These guidelines are intended for use by all practitioners and health workers who require information about the management of patients with locally advanced and metastatic prostate cancer. They are wide-ranging in scope, covering prevention, screening, diagnosis and psychosocial matters, as well as the clinical aspects of surgery, radiotherapy and chemotherapy.
The guidelines have been produced by a process of systematic literature review; critical appraisal and consultation encompassing all interested parties in Australia (see Appendix - Guideline development process)
The Summary of Recommendations table above provides a list of the evidence-based recommendations detailed in the text of each section. Table 1 below provides details on the highest level of evidence identified to support each recommendation (I-IV). The Summary of Recommendations table includes the grade for each recommendation (A-D) as shown in the table below. Individual levels of evidence can be found in the Evidence Summaries for each recommendation in each question.
Each recommendation 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.
| Grade of recommendation
|
Description
|
| A
|
Body of evidence can be trusted to guide practice
|
| B
|
Body of evidence can be trusted to guide practice in most situations
|
| C
|
Body of evidence provides some support for recommendation(s) but care should be taken in its application
|
| D
|
Body of evidence is weak and recommendation must be applied with caution
|
Table 1. Designations of levels of evidence according to type of research question (NHMRC, 2005)
| Level
|
Intervention
|
| I
|
A systematic review of level II studies
|
| II
|
A randomised controlled trial
|
| III-1
|
A pseudo-randomised controlled trial (i.e. alternate allocation or some other method)
|
| III-2
|
A comparative study with concurrent controls:
- Non-randomised, experimental trial
- Cohort study
- Case-control study
- Interrupted time series with a control group
|
| III-3
|
A comparative study without concurrent controls:
- Historical control study
- Two or more single arm study
- Interrupted time series without a parallel control group
|
| IV
|
Case series with either post-test or pre-test/post-test outcomes
|
