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Prostate cancer

About

What is covered

This interactive flowchart covers the diagnosis and management of prostate cancer in secondary care, including information on the best way to diagnose and identify different stages of the disease, and how to manage adverse effects of treatment. It also includes recommendations on follow-up in primary care for people diagnosed with prostate cancer.

Updates

Updates to this interactive flowchart

14 May 2019 Enzalutamide for hormone-relapsed non-metastatic prostate cancer (NICE technology appraisal guidance 580) added to hormone therapy.
8 May 2019 Major update on publication of the prostate cancer: diagnosis and management guideline update (NICE guideline NG131).
20 November 2018 Padeliporfin for untreated localised prostate cancer (NICE technology appraisal guidance 546) added to low- and intermediate-risk localised prostate cancer.
31 January 2018 Memokath-051 stent for ureteric obstruction (NICE medical technologies guidance 35) added to obstructive uropathy.
22 August 2017 Biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer (NICE interventional procedures guidance 590) added to radiotherapy.
20 December 2016 Irreversible electroporation for treating prostate cancer (NICE interventional procedures guidance 572) added to cryotherapy, electroporation and ultrasound.
27 September 2016 Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases (NICE technology appraisal guidance 412) added to bone metastases.
23 August 2016 Structure revised, and summarised recommendations replaced with full recommendations. Degarelix for treating advanced hormone-dependent prostate cancer (NICE technology appraisal guidance 404) added to treatment. Recommendations for cabazitaxel updated in treatment options after chemotherapy with a docetaxel regimen.
24 May 2016 Cabazitaxel for hormone-relapsed metastatic prostate cancer previously treated with a docetaxel-containing regimen (NICE technology appraisal guidance 391) added to treatment options after chemotherapy with a docetaxel regimen.
26 April 2016 Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (NICE technology appraisal guidance 387) added to treatment options before chemotherapy is indicated.
26 January 2016
  • Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (NICE technology appraisal guidance 377) added to treatment options before chemotherapy is indicated.
  • Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases (NICE technology appraisal guidance 376) added to bone metastases.
9 November 2015 The dose of cyproterone acetate for managing hot flushes has been amended, and the reference to megestrol acetate has been removed because it is not available in the UK at the dose needed. The changes have been made in managing adverse effects of hormone therapy.
1 July 2015 Sipuleucel-T for treating asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer (NICE technology appraisal guidance 332) removed after the withdrawal of its marketing authorisation.
10 June 2015 Prostate cancer (NICE quality standard 91) added.
24 February 2015 Sipuleucel-T for treating asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer (NICE technology appraisal guidance 332) added to treatment options after chemotherapy with a docetaxel regimen.
22 July 2014 Enzalutamide for metastatic hormone-relapsed prostate cancer previously treated with a docetaxel-containing regimen (NICE technology appraisal guidance 316) added to treatment options after chemotherapy with a docetaxel regimen.
23 October 2012 Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours (NICE technology appraisal guidance 265) added to treatment.
27 June 2012 Abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen (NICE technology appraisal guidance 259) added to treatment options after chemotherapy with a docetaxel regimen.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Short Text

Everything NICE has said on diagnosing and treating prostate cancer in an interactive flowchart

What is covered

This interactive flowchart covers the diagnosis and management of prostate cancer in secondary care, including information on the best way to diagnose and identify different stages of the disease, and how to manage adverse effects of treatment. It also includes recommendations on follow-up in primary care for people diagnosed with prostate cancer.

Updates

Updates to this interactive flowchart

14 May 2019 Enzalutamide for hormone-relapsed non-metastatic prostate cancer (NICE technology appraisal guidance 580) added to hormone therapy.
8 May 2019 Major update on publication of the prostate cancer: diagnosis and management guideline update (NICE guideline NG131).
20 November 2018 Padeliporfin for untreated localised prostate cancer (NICE technology appraisal guidance 546) added to low- and intermediate-risk localised prostate cancer.
31 January 2018 Memokath-051 stent for ureteric obstruction (NICE medical technologies guidance 35) added to obstructive uropathy.
22 August 2017 Biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer (NICE interventional procedures guidance 590) added to radiotherapy.
20 December 2016 Irreversible electroporation for treating prostate cancer (NICE interventional procedures guidance 572) added to cryotherapy, electroporation and ultrasound.
27 September 2016 Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases (NICE technology appraisal guidance 412) added to bone metastases.
23 August 2016 Structure revised, and summarised recommendations replaced with full recommendations. Degarelix for treating advanced hormone-dependent prostate cancer (NICE technology appraisal guidance 404) added to treatment. Recommendations for cabazitaxel updated in treatment options after chemotherapy with a docetaxel regimen.
24 May 2016 Cabazitaxel for hormone-relapsed metastatic prostate cancer previously treated with a docetaxel-containing regimen (NICE technology appraisal guidance 391) added to treatment options after chemotherapy with a docetaxel regimen.
26 April 2016 Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (NICE technology appraisal guidance 387) added to treatment options before chemotherapy is indicated.
26 January 2016
  • Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (NICE technology appraisal guidance 377) added to treatment options before chemotherapy is indicated.
  • Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases (NICE technology appraisal guidance 376) added to bone metastases.
9 November 2015 The dose of cyproterone acetate for managing hot flushes has been amended, and the reference to megestrol acetate has been removed because it is not available in the UK at the dose needed. The changes have been made in managing adverse effects of hormone therapy.
1 July 2015 Sipuleucel-T for treating asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer (NICE technology appraisal guidance 332) removed after the withdrawal of its marketing authorisation.
10 June 2015 Prostate cancer (NICE quality standard 91) added.
24 February 2015 Sipuleucel-T for treating asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer (NICE technology appraisal guidance 332) added to treatment options after chemotherapy with a docetaxel regimen.
22 July 2014 Enzalutamide for metastatic hormone-relapsed prostate cancer previously treated with a docetaxel-containing regimen (NICE technology appraisal guidance 316) added to treatment options after chemotherapy with a docetaxel regimen.
23 October 2012 Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours (NICE technology appraisal guidance 265) added to treatment.
27 June 2012 Abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen (NICE technology appraisal guidance 259) added to treatment options after chemotherapy with a docetaxel regimen.

Sources

NICE guidance and other sources used to create this interactive flowchart.
Prostate cancer: diagnosis and management (2019) NICE guideline NG131
Improving outcomes in urological cancers (2002) NICE guideline CSG2
Enzalutamide for hormone-relapsed non-metastatic prostate cancer (2019) NICE technology appraisal guidance 580
Padeliporfin for untreated localised prostate cancer (2018) NICE technology appraisal guidance 546
Degarelix for treating advanced hormone-dependent prostate cancer (2016) NICE technology appraisal guidance 404
Irreversible electroporation for treating prostate cancer (2016) NICE interventional procedures guidance 572
Focal therapy using cryoablation for localised prostate cancer (2012) NICE interventional procedures guidance 423
Transperineal template biopsy and mapping of the prostate (2010) NICE interventional procedures guidance 364
Laparoscopic radical prostatectomy (2006) NICE interventional procedures guidance 193
Cryotherapy as a primary treatment for prostate cancer (2005) NICE interventional procedures guidance 145
Low dose rate brachytherapy for localised prostate cancer (2005) NICE interventional procedures guidance 132
Cryotherapy for recurrent prostate cancer (2005) NICE interventional procedures guidance 119
High-intensity focused ultrasound for prostate cancer (2005) NICE interventional procedures guidance 118
Memokath-051 stent for ureteric obstruction (2018) NICE medical technologies guidance 35
Prostate cancer (2015) NICE quality standard 91
Hormone-sensitive metastatic prostate cancer: docetaxel (2016) NICE evidence summary ESUOM50
Erectile dysfunction: avanafil (2014) NICE evidence summary ESNM45
Prostate cancer: triptorelin (Decapeptyl SR) (2014) NICE evidence summary ESNM30
Axumin for functional imaging of prostate cancer recurrence (2019) NICE medtech innovation briefing 172

Quality standards

Prostate cancer

These quality statements are taken from the prostate cancer quality standard. The quality standard defines clinical best practice for prostate cancer care and should be read in full.

Quality statements

Discussion with a named nurse specialist

This quality statement is taken from the prostate cancer quality standard. The quality standard defines clinical best practice in prostate cancer care and should be read in full.

Quality statement

People with prostate cancer have a discussion about treatment options and adverse effects with a named nurse specialist.

Rationale

Nurse specialists are key points of contact for people with prostate cancer. They provide information about treatment options, answer questions or concerns and support people to make decisions about their care. This is particularly important immediately after diagnosis and when difficult choices about treatment need to be made. Nurse specialists also provide personalised care plans and information about support services.

Quality measures

Structure
Evidence of local arrangements to ensure that people with prostate cancer have a discussion about treatment options and adverse effects with a named nurse specialist.
Process
Proportion of people with prostate cancer who have a recorded discussion about treatment options and adverse effects with a named nurse specialist.
Numerator – the number in the denominator who have a recorded discussion about treatment options and adverse effects with a named nurse specialist.
Denominator – the number of people with prostate cancer.
Outcome
Rates of people with prostate cancer satisfied with the discussion about treatment options and adverse effects.
Data source: Local data collection and National Cancer Patient Experience Survey 2014.

What the quality statement means for different audiences

Service providers (such as hospitals, specialist prostate cancer multidisciplinary teams and specialist prostate cancer services) ensure that people with prostate cancer have a discussion about treatment options and adverse effects with a named nurse specialist.
Healthcare professionals ensure that people with prostate cancer have a discussion about treatment options and adverse effects with a named nurse specialist.
Commissioners (such as clinical commissioning groups and NHS England area teams) ensure that the services they commission have sufficient nurse specialists available to offer a discussion about treatment options and adverse effects to people with prostate cancer.
People with prostate cancer have a discussion about treatment options and adverse effects with a named nurse with experience in prostate cancer. They feel informed about their treatment options and side effects, and supported to make decisions about their treatment.

Source guidance

Definitions of terms used in this quality statement

Adverse effects
Adverse effects of prostate cancer treatment may include:
  • sexual dysfunction
  • loss of libido
  • impotence
  • urinary incontinence
  • radiation-induced enteropathy
  • hot flushes
  • osteoporosis
  • cardiovascular complications
  • gynaecomastia
  • fatigue
  • weight gain
  • metabolic syndrome.
[Adapted from NICE guideline on prostate cancer]
Nurse specialist
A nurse with a urology or oncology background who is a specialist in the management of prostate cancer.
[Expert opinion]
Support services
Supportive care includes a number of services, both generalist and specialist, that may be required to support people with cancer and their carers.

Equality and diversity considerations

People of black African or Caribbean family origin are more likely to develop prostate cancer than other people. Despite this, awareness of prostate cancer is low among people in these groups and the nurse specialist should be aware of this when discussing prostate cancer with them.
Similarly, older people are at higher risk of developing prostate cancer than younger people, but may be less likely to continue to engage with health services after the initial contact. The nurse specialist should be aware of this when discussing prostate cancer with older people.
People who are gay, bisexual or transgender have a risk of developing prostate cancer. Healthcare professionals should be aware of their psychosexual needs, lifestyle and the impact of different treatment options.

Treatment options

This quality statement is taken from the prostate cancer quality standard. The quality standard defines clinical best practice in prostate cancer care and should be read in full.

Quality statement

People with low-risk localised prostate cancer for whom radical treatment is suitable are offered a choice between active surveillance, radical prostatectomy or radical radiotherapy.

Rationale

People who are diagnosed with low risk localised prostate cancer can be offered different treatment options, including radical prostatectomy, radical radiotherapy and active surveillance. It is important that people for whom it is suitable know that active surveillance is also an option for low risk localised prostate cancer. This can reduce overtreatment and increase capacity for rapid treatment of high risk disease. It can also reduce the number of people unnecessarily having radical treatment and therefore experiencing adverse effects, and decrease the cost of treating and managing these adverse effects. By discussing all the treatment options available to them, people can make an informed decision on their preferred option.

Quality measures

Structure
Evidence of local arrangements to ensure that people with low risk localised prostate cancer for whom radical treatment is suitable are offered a choice between active surveillance, radical prostatectomy or radical radiotherapy.
Data source: Local data collection.
Process
Proportion of people with low risk localised prostate cancer for whom radical treatment is suitable who are offered a choice between active surveillance, radical prostatectomy or radical radiotherapy.
Numerator – the number in the denominator who are offered a choice between active surveillance, radical prostatectomy or radical radiotherapy.
Denominator – the number of people with low risk localised prostate cancer for whom radical treatment is suitable.
Data source: Local data collection.
Outcome
a) Rates of people with low risk localised prostate cancer on active surveillance.
Data source: Local data collection.
b) Rates of people with low risk localised prostate cancer satisfied with their chosen treatment option.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (such as hospitals, specialist urological cancer multidisciplinary teams and specialist prostate cancer services) ensure that systems are in place to offer a choice between active surveillance, radical prostatectomy or radical radiotherapy to people with low risk localised prostate cancer for whom radical treatment is suitable.
Healthcare professionals (such as clinical commissioning groups and NHS England area teams) should monitor the treatment options offered to people with low risk localised prostate cancer.
Commissioners (such as clinical commissioning groups and NHS England area teams) should monitor the treatment options offered to people with low risk localised prostate cancer.
People whose cancer has not spread outside the prostate and whose future risk from the cancer is low are offered a choice between having regular tests but no treatment (known as active surveillance), surgery to remove the prostate (radical prostatectomy) or radiation treatment to destroy cancer cells (radiotherapy).

Source guidance

Prostate cancer: diagnosis and management (2019) NICE guideline NG131, recommendations 1.3.7 and 1.3.8 and 1.3.9

Definitions of terms used in this quality statement

Active surveillance
Part of a curative strategy for people with localised prostate cancer for whom radical treatments are suitable. It keeps these people within a ‘window of curability’ whereby only those whose tumours are showing signs of progressing or those with a preference for intervention are considered for radical treatment. Active surveillance may therefore avoid or delay the need for radiation or surgery.
Active surveillance follows the protocol outlined in table 4 in NICE’s guideline on prostate cancer.
[NICE’s guideline on prostate cancer, 2014 full guideline]
Low-risk localised prostate cancer
Prostate-specific antigen (PSA) less than 10 ng/ml, Gleason score 6 or below and clinical stage T1–T2A (confined to the prostate gland).
[Adapted from NICE’s guideline on prostate cancer]
Radical prostatectomy
Removal of the entire prostate gland and lymph nodes by open surgery or a keyhole technique (laparoscopic or robotically assisted laparoscopic prostatectomy).
[NICE’s guideline on prostate cancer, 2014 full guideline]
Radical radiotherapy
Radiation, usually X-rays or gamma rays, used to destroy tumour cells, by external beam radiotherapy or brachytherapy.
[NICE’s guideline on prostate cancer, 2014 full guideline]

Equality and diversity considerations

People of black African or Caribbean family origin are more likely to develop prostate cancer than others. Despite this, awareness of prostate cancer is low among people in these groups. Similarly, older people are at higher risk of developing prostate cancer than younger people, but may be less likely to continue to engage with health services even after the initial contact with the service. For people in these groups for whom active surveillance is suitable, healthcare professionals should highlight its importance as a treatment option.
People who are gay, bisexual or transgender have a risk of developing prostate cancer. Healthcare professionals should be aware of their psychosexual needs, lifestyle and the impact of different treatment options.

Combination therapy

This quality statement is taken from the prostate cancer quality standard. The quality standard defines clinical best practice in prostate cancer care and should be read in full.

Quality statement

People with intermediate or high risk localised prostate cancer who are offered non surgical radical treatment are offered radical radiotherapy and androgen deprivation therapy in combination.

Rationale

Androgen deprivation therapy and radiotherapy are 2 of the treatment options available for people with intermediate or high risk localised prostate cancer. Combining androgen deprivation therapy with radical radiotherapy can increase the effectiveness of treatment and the chances of survival compared with either androgen deprivation therapy or radical radiotherapy alone.

Quality measures

Structure
Evidence of local arrangements to ensure that people with intermediate or high risk localised prostate cancer who are offered non surgical radical treatment are offered radical radiotherapy and androgen deprivation therapy in combination.
Data source: Local data collection.
Process
Proportion of people with intermediate or high risk localised prostate cancer receiving non surgical radical treatment, who receive radical radiotherapy and androgen deprivation therapy in combination.
Numerator – the number in the denominator who received radical radiotherapy and androgen deprivation therapy in combination.
Denominator – the number of people with intermediate or high risk localised prostate cancer receiving non surgical radical treatment.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (such as hospitals, specialised urological cancer multidisciplinary teams and specialised prostate cancer services) ensure that healthcare professionals know that radical radiotherapy and androgen deprivation therapy should be used only in combination for people with intermediate or high risk localised prostate cancer.
Healthcare professionals ensure that people with intermediate or high risk localised prostate cancer who are offered non surgical radical treatment receive radical radiotherapy and androgen deprivation therapy in combination.
Commissioners (such as clinical commissioning groups and NHS England area teams) monitor whether people with intermediate or high risk localised prostate cancer offered non surgical radical treatment are offered radical radiotherapy and androgen deprivation therapy in combination. Commissioners may wish to ask providers for evidence of practice.
People whose cancer has not spread outside the prostate and whose future risk from the cancer is medium or high are offered treatment of combined radiation treatment to destroy the cancer cells (called radiotherapy) and a drug that blocks the production of androgen, a hormone that helps cancer cells to grow, (called androgen deprivation therapy). Having radiotherapy together with androgen deprivation therapy usually works better than having just one of these treatments on its own.

Source guidance

Prostate cancer: diagnosis and management (2019) NICE guideline NG131, recommendation 1.3.19

Definitions of terms used in this quality statement

Androgen deprivation therapy
Treatment with a luteinising hormone-releasing hormone agonist such as goserelin to lower testosterone levels.
[Adapted from NICE’s guideline on prostate cancer, 2014 full guideline]
High-risk localised prostate cancer
Prostate-specific antigen (PSA) greater than 20 ng/ml, Gleason score 8–10 or clinical stage T2C or greater.
[NICE’s guideline on prostate cancer]
Intermediate-risk localised prostate cancer
PSA 10–20 ng/ml, Gleason score 7 or clinical stage T2B.
[NICE’s guideline on prostate cancer]
Radical radiotherapy
Radiation, usually X-rays or gamma rays, used to destroy tumour cells by external beam radiotherapy or brachytherapy.
[Adapted from NICE’s guideline on prostate cancer, 2014 full guideline]

Equality and diversity considerations

Some older people may have previously been offered androgen deprivation therapy alone. Focusing on the benefits of combination therapy for older people with intermediate or high risk localised prostate cancer should help to reduce such inequalities.
People who are gay, bisexual or transgender have a risk of developing prostate cancer. Healthcare professionals should be aware of their psychosexual needs, lifestyle and the impact of different treatment options.

Managing adverse effects of treatment

This quality statement is taken from the prostate cancer quality standard. The quality standard defines clinical best practice in prostate cancer care and should be read in full.

Quality statement

People with adverse effects of prostate cancer treatment are referred to specialist services.

Rationale

Treatments for prostate cancer have various adverse effects that can continue after the treatment is completed. Adverse effects include sexual dysfunction, loss of libido, impotence, urinary incontinence, radiation induced enteropathy, hot flushes, osteoporosis, cardiovascular complications, gynaecomastia and fatigue. These adverse effects can also have an emotional and psychological impact on people. Specialist services that provide interventions such as counselling, drug therapy, radiotherapy, physiotherapy and aerobic exercise can help to manage adverse effects of treatment and substantially improve the person’s quality of life.

Quality measures

Structure
Evidence of local arrangements to ensure that people with adverse effects of prostate cancer treatment are referred to specialist services.
Data source: Local data collection and the National Prostate Cancer Audit.
Process
Proportion of people with adverse effects of prostate cancer treatment who use specialist services.
Numerator – the number in the denominator who use specialist services.
Denominator – the number of people with adverse effects of prostate cancer treatment.
Data source: Local data collection and the National Prostate Cancer Audit.

What the quality statement means for different audiences

Service providers (such as hospitals, specialist urological cancer multidisciplinary teams and specialist prostate cancer services) ensure that systems are in place for people with adverse effects of prostate cancer treatment to be referred to specialist services.
Healthcare professionals refer people with adverse effects of prostate cancer treatment to specialist services.
Commissioners (such as clinical commissioning groups and NHS England area teams) have pathways in place to ensure that men with adverse effects of prostate cancer treatment are referred to specialist services.
People who have side effects from prostate cancer treatment are referred to specialist services (such as erectile dysfunction or continence services) to help stop or ease the side effects.

Source guidance

Prostate cancer: diagnosis and management (2019) NICE guideline NG131, recommendations 1.3.33, 1.3.36, 1.3.39, 1.4.3, 1.4.8, 1.4.13, 1.4.14, 1.4.16, 1.4.18 and 1.4.19

Definitions of terms used in this quality statement

Adverse effects
Adverse effects include:
  • sexual dysfunction
  • loss of libido
  • impotence
  • urinary incontinence
  • radiation-induced enteropathy
  • hot flushes
  • osteoporosis
  • cardiovascular complications
  • gynaecomastia
  • fatigue
  • weight gain
  • metabolic syndrome.
[Adapted from NICE’s guideline on prostate cancer]
Specialist services
The specialist services include erectile dysfunction services, continence services and psychosexual counselling.
[Adapted from NICE’s guideline on prostate cancer]

Equality and diversity considerations

Older people may need encouragement to engage with specialist services as they tend not to use the health service as much as other people.
People who are gay, bisexual or transgender have a risk of developing prostate cancer. Healthcare professionals should be aware of their psychosexual needs, lifestyle and the impact of different treatment options.

Hormone-relapsed metastatic prostate cancer

This quality statement is taken from the prostate cancer quality standard. The quality standard defines clinical best practice in prostate cancer care and should be read in full.

Quality statement

People with hormone relapsed metastatic prostate cancer have their treatment options discussed by the urological cancer multidisciplinary team (MDT).

Rationale

Discussion by the urological cancer MDT is a means of ensuring that an opinion from an oncologist and/or palliative care specialist is obtained. Having a variety of opinions from experts who are aware of all current treatment options means that there is a better chance to identify the best options for the person. Those options can then be discussed with the person.

Quality measures

Structure
Evidence of local arrangements to ensure that people with hormone relapsed metastatic disease have their treatment options discussed by the urological cancer MDT.
Data source: Local data collection and the National Prostate Cancer Audit.
Process
Proportion of people with hormone relapsed metastatic disease who have their treatment options discussed by the urological cancer MDT.
Numerator – the number in the denominator who have their treatment options discussed by the urological cancer MDT.
Denominator – the number of people with hormone relapsed metastatic prostate cancer.
Data source: Local data collection and the National Prostate Cancer Audit.

What the quality statement means for different audiences

Service providers (such as hospitals, specialist urological cancer MDTs and specialist prostate cancer services) ensure that systems are in place for people with hormone relapsed metastatic prostate cancer to have their treatment options discussed by the urological cancer MDT.
Healthcare professionals ensure that people with hormone relapsed metastatic prostate cancer have their treatment options discussed by the urological cancer MDT.
Commissioners (such as clinical commissioning groups and NHS England area teams) monitor whether providers have systems in place to ensure that people with hormone relapsed metastatic prostate cancer have their treatment options discussed by the urological cancer MDT.
People with cancer that has spread outside the prostate and whose drug treatment (to block the production of hormones that help cancer cells to grow) has stopped working have their treatment options discussed by a specialist team of healthcare professionals with different kinds of expertise in prostate cancer. This is to make sure that all the different treatment options are discussed and all suitable treatments are offered.

Source guidance

Prostate cancer: diagnosis and management (2019) NICE guideline NG131, recommendation 1.5.11

Definitions of terms used in this quality statement

Hormone-relapsed prostate cancer
Prostate cancer after failure of primary androgen deprivation therapy.
[NICE’s guideline on prostate cancer, 2014 full guideline]
Urological cancer MDT
A team that includes specialists in urology, oncology, pathology, radiology, palliative care, diet and nursing.
[Adapted from NICE’s guideline on prostate cancer, full guideline and the British Uro Oncology Group and British Association of Urological Surgeons MDT (multi-disciplinary team) guidance for managing prostate cancer]

Effective interventions library

Effective interventions library

Successful effective interventions library details

Implementation

Information for the public

NICE has written information for the public on each of the following topics.

Pathway information

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Supporting information

Factors to consider when discussing the option of docetaxel chemotherapy for people with high-risk, non-metastatic prostate cancer

What does treatment with docetaxel involve?
Docetaxel chemotherapy is given at 6 appointments, each 3 weeks apart. It is given as an intravenous infusion that takes about 1 hour.
What are the benefits of docetaxel treatment for people with high-risk, non-metastatic prostate cancer?
  • There is clear, high-quality evidence that docetaxel chemotherapy delays disease progression in people with high-risk, non-metastatic disease.
  • In a large UK randomised triala, the average person who did not receive docetaxel experienced disease progression about 5 years after the start of the trial, whereas the average person receiving docetaxel experienced disease progression after about 6 years.
  • We do not yet know whether docetaxel improves survival in people with high-risk, non-metastatic disease and we will only be confident about whether it does when trials have been running for longer.
  • In a large UK randomised trial, 80 out of 100 people with high-risk disease who did not receive docetaxel were still alive after 5 years compared to 84 out of 100 people who did. However, this difference could be because of chance.
What are the risks associated with docetaxel treatment?
A large UK randomised trial found that:
  • 15 out of 100 people who took docetaxel developed febrile neutropenia (that is, they got a fever because the chemotherapy had reduced their white blood cells' ability to fight infection).
  • 1 out of 100 people who took docetaxel died because of infections that, in the opinion of the investigators, they might not have developed if they had not received docetaxel.
  • 8 out of 100 people who took docetaxel felt unusually weak or tired.
  • 8 out of 100 people who took docetaxel experienced gastrointestinal symptoms (including diarrhoea, abdominal pain, constipation and/or vomiting).
  • 5 out of 100 people who took docetaxel experienced respiratory symptoms (including breathlessness and/or chest infections).
  • 4 out of 100 people who took docetaxel experienced problems with their nervous systems (for example, numbness or weakness).
  • 1 out of 100 people who took docetaxel experienced problems with their nails that were serious enough to interfere with their daily lives.
aJames ND, Sydes MR, Clarke NW et al. (2016) Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 387(10024): 1163–77.

Factors to consider when discussing active surveillance, radical prostatectomy or radical radiotherapy as treatment options for people with low-risk or intermediate-risk localised prostate cancer, using evidence from a large UK trial

What are the treatment options for people with localised prostate cancer?
There are 3 options for treatment:
Effects on survival and disease progression at 10 years
What effect does each treatment option have on survival?
The evidence does not show a difference in the number of deaths from prostate cancer among people offered active surveillance, prostatectomy or radical radiotherapy.
People who had not died of prostate cancer were:
  • 98 out of 100 patients offered active surveillance
  • 99 out of 100 patients offered radical prostatectomy
  • 99 out of 100 patients offered radical radiotherapy.
What effect does each treatment option have on disease progressionb?
There is good evidence that both prostatectomy and radiotherapy reduce disease progression compared with active surveillance.
Signs of disease progression were reported in:
  • 21 out of 100 patients offered active surveillance
  • 8 out of 100 patients offered radical prostatectomy
  • 8 out of 100 patients offered radical radiotherapy.
What effect does each treatment option have on the rate of development of distant metastases?
There is good evidence that both prostatectomy and radiotherapy reduce the rate of development of distant metastases compared with active surveillance.
Distant metastases were developed in:
  • 8 out of 100 patients offered active surveillance
  • 3 out of 100 patients offered radical prostatectomy
  • 3 out of 100 patients offered radical radiotherapy.
Potential side effects of treatment
What effect does each treatment option have on urinary function?
There is some evidence that urinary function is better for people offered active surveillance or radiotherapy than those offered prostatectomy.
Problems with urinary continence:
At 6 months, problems were reported in:
  • 39 out of 100 patients offered active surveillance
  • 71 out of 100 patients offered radical prostatectomy
  • 38 out of 100 patients offered radical radiotherapy.
At 6 years, problems were reported in:
  • 50 out of 100 patients offered active surveillance
  • 69 out of 100 patients offered radical prostatectomy
  • 49 out of 100 patients offered radical radiotherapy.
Moderate to severe urinary incontinence problems:
At 6 months, problems were reported in:
  • 4 out of 100 patients offered active surveillance
  • 19 out of 100 patients offered radical prostatectomy
  • 6 out of 100 patients offered radical radiotherapy.
At 6 years, problems were reported in:
  • 8 out of 100 patients offered active surveillance
  • 13 out of 100 patients offered radical prostatectomy
  • 5 out of 100 patients offered radical radiotherapy.
What effect does each treatment option have on erectile dysfunction?
There is some limited evidence that sexual function is better for people offered active surveillance or radiotherapy than those offered prostatectomy.
Erectile dysfunction, moderate or severe problems:
At 6 months, problems were reported in:
  • 29 out of 100 patients offered active surveillance
  • 66 out of 100 patients offered radical prostatectomy
  • 48 out of 100 patients offered radical radiotherapy.
At 6 years, problems were reported in:
  • 40 out of 100 patients offered active surveillance
  • 50 out of 100 patients offered radical prostatectomy
  • 36 out of 100 patients offered radical radiotherapy.
What effect does each treatment option have on bowel function?
There is some evidence that bowel function is better for people offered active surveillance or prostatectomy than those offered radiotherapy in the short term.
Problems with faecal incontinence more than once per week:
At 6 months, problems were reported in:
  • 2 out of 100 patients offered active surveillance
  • 1 out of 100 patients offered radical prostatectomy
  • 5 out of 100 patients offered radical radiotherapy.
At 6 years, problems were reported in:
  • 3 out of 100 patients offered active surveillance
  • 2 out of 100 patients offered radical prostatectomy
  • 4 out of 100 patients offered radical radiotherapy.
Moderate to severe impact of bowel habits on quality of life:
At 6 months, it was reported in:
  • 3 out of 100 patients offered active surveillance
  • 3 out of 100 patients offered radical prostatectomy
  • 10 out of 100 patients offered radical radiotherapy.
At 6 years, it was reported in:
  • 4 out of 100 patients offered active surveillance
  • 3 out of 100 patients offered radical prostatectomy
  • 2 out of 100 patients offered radical radiotherapy.
a The trial used the intention-to-treat method of analysis and some of the patients in the active surveillance arm may therefore have undergone prostatectomy or radiotherapy during the follow-up period.
b The trial defined disease progression as:
  • evidence of metastases or
  • diagnosis of clinical T3 or T4 disease or
  • need for long-term androgen deprivation therapy or
  • rectal fistula or the need for a urinary catheter owing to local tumour growth.
Disease progression was suspected if there was:
  • any rise in PSA >20% between consecutive measures at any time during follow-up or
  • any rise in PSA level of 50% or greater in any 12-month period confirmed by repeat tests or
  • any indication of the appearance of symptomatic systemic disease.

Factors to consider when discussing the options for people whose multiparametric MRI Likert score is 1 or 2

Advantages of undergoing prostate biopsy
Disadvantages of undergoing prostate biopsy
You may have prostate cancer that the MRI scan missed:
  • between 11 and 28 out of 100 people with a low-risk MRI actually have clinically significant cancer
  • there are many effective treatments for clinically significant cancer, which work best for disease that is caught early; this means that, if you actually do have clinically significant cancer that the MRI missed, you will have a better chance of long-term survival if the biopsy finds it.
There is no guarantee that a prostate biopsy will find any disease that is there. Prostate biopsies find less than half of the clinically significant prostate cancers that MRI scans miss.
You may be diagnosed with clinically insignificant prostate cancer. This is disease that is unlikely to be life-threatening, but will need monitoring and may lead to treatment. Therefore, if someone has prostate cancer that truly is clinically insignificant, it is better not to find it. Between 18 and 23 out of 100 people with a low-risk MRI get a diagnosis of clinically insignificant prostate cancer if they have a prostate biopsy.
The most common type of biopsy, TRUS, has some rare but important complications. The most serious is sepsis, which develops in a bit less than 1 out of 100 people. Other serious complications, including acute urinary retention, severe haematuria and severe rectal bleeding may need hospitalisation.
TRUS biopsy has less serious complications that make it unpleasant to undergo for some people. On average:
  • 3 out of 100 people feel light-headed or dizzy immediately after the biopsy
  • 44 out of 100 people report pain; in 15 of them, it will last for at least 2 weeks; 7 will consider it a moderate or serious problem
  • 20 out of 100 people develop a fever; in 3 of them, it will last for at least 2 weeks; 5 will consider it a moderate or serious problem
  • 66 out of 100 people have blood in their urine; in 20 of them, it will last for at least 2 weeks; 6 will consider it a moderate or serious problem
  • 37 out of 100 people have blood in their bowel movements; in 5 of them, it will last for at least 2 weeks; 2 will consider it a moderate or serious problem
  • 90 out of 100 people have blood in their semen; in 60 of them, it will last for at least 2 weeks; 25 will consider it a moderate or serious problem.
There is more than 1 type of prostate biopsy. The most common approach is TRUS biopsy. The data in this table come from the PROMIS and ProtecT studies, which used TRUS. There are no equivalent data for other types of biopsy.
The ranges given in the figures above reflect different definitions of clinically significant prostate cancer (UCL1 and UCL2; see PROMIS publications).

Rationale: padeliporfin

Current treatments for low-risk prostate cancer include active surveillance and, for people whose disease has progressed (usually beyond low-risk disease), radical therapies such as surgery and radiotherapy. Focal therapies such as cryotherapy and high-intensity focused ultrasound can also be used, but are not routinely available.
Professional organisations and NHS England say that there is a growing trend for people with low-risk disease to have active surveillance rather than radical therapy. This is because long-term studies show that people with low-risk disease live as long whichever they have, but radical therapies are associated with long-term, severe side effects. Also, improvements in diagnostic tests mean that low-risk disease can be more accurately identified.
The company proposes padeliporfin as an option for people with low-risk disease who choose not to have active surveillance and so would otherwise have radical therapies. There is no clinical evidence on how effective padeliporfin is at slowing the disease compared with radical therapies. Also, there is no evidence to support the company's assumption that the length of time people live with padeliporfin is the same as with radical therapies.
Clinical trial evidence comparing padeliporfin with active surveillance does show that, at 2 years, it is more effective at slowing prostate cancer. However, it is unclear whether the benefit seen at 2 years leads to people living longer. Also, it is unclear whether some of the people in the trial would have had intermediate-risk prostate cancer.
Professional organisations and NHS England do not support using padeliporfin for low-risk prostate cancer because, like radical therapies, it is associated with long-term side effects, without supporting evidence of long-term clinical benefit.
The company's cost-effectiveness analyses compare padeliporfin with radical therapies. However, because there is no clinical-effectiveness evidence comparing padeliporfin and radical therapies, it is not possible to consider these analyses. Therefore, padeliporfin cannot be recommended for untreated, unilateral, low-risk prostate cancer.
For more information see the committee discussion in the NICE technology appraisal guidance on padeliporfin for untreated localised prostate cancer.
Do not offer immediate post-operative radiotherapy after radical prostatectomy, even to people with margin-positive disease, other than in the context of a clinical trial.
Do not offer bisphosphonates for the prevention of bone metastases in people with prostate cancer.
Follow up people with prostate cancer who have chosen a watchful waiting regimen with no curative intent in primary care only if protocols for this have been agreed between the local urological cancer MDT and the relevant primary care organisation(s). Measure their PSA at least once a year.
Surgery to remove part, or all of the prostate gland. Radical prostatectomy aims at the removal of the entire prostate gland and lymph nodes. This can be performed by an open approach or by keyhole technique (laparoscopic or robotically assisted laparoscopic prostatectomy).
This is part of a strategy for 'controlling' rather than 'curing' prostate cancer and is aimed at people with localised prostate cancer who do not ever wish to have curative treatment, or it is not suitable for them. Instead, it involves the deferred use of hormone therapy. Watchful waiting avoids the use of surgery or radiation, but implies that curative treatment will not be attempted.
This is part of a 'curative' strategy and is aimed at people with localised prostate cancer for whom radical treatments are suitable, keeping them within a 'window of curability' whereby only those whose tumours are showing signs of progressing, or those with a preference for intervention are considered for radical treatment. Active surveillance may thus avoid or delay the need for radiotherapy or surgery.
A template biopsy is normally performed under a general anaesthetic, and involves taking transperineal core biopsies using a grid system. This might involve taking multiple cores from multiple sites, but usually 2 to 3 cores from 8 sites. A mapping template biopsy is where 20 sites are systematically sampled, with 2 or 3 cores per site, sometimes meaning over 50 core biopsies are taken.
The information from the mpMRI scan taken before prostate biopsy is used to determine the best needle placement. In rare cases, the biopsy may be MRI-guided (the needle is inserted within the MRI machine). In most cases, the biopsy that follows the mpMRI will be ultrasound-guided, but the specific area(s) targeted will be predetermined by the mpMRI data.
The site for biopsy can be targeted based on multiparametric MRI findings, or systematically but not guided by MRI. Most often there is a combination of both targeted and systematic MRI. The method used for the biopsy can be either transperineal or TRUS.

Glossary

atypical small acinar proliferation
(this includes any prostate cancer of Gleason score 7 and above)
digital rectal examination
Eastern Cooperative Oncology Group
(this is radiotherapy given by using ionising radiation [for example, high energy X-rays] produced in a machine and directed at the tumour from outside the patient)
high-grade prostatic intra-epithelial neoplasia
(refers to prostate cancer after failure of primary androgen deprivation therapy)
intensity modulated radiation therapy
(cancer that has been staged as T1 or T2 [confined to the prostate gland])
(this includes: high-risk localised prostate cancer [PSA over 20 ng/ml, or Gleason score 8 to 10, or clinical stage T2c or more]; T3b and T4, N0 prostate cancer; and any T, N1 prostate cancer)
multidisciplinary team
multidisciplinary teams
(an MRI study that incorporates anatomical and functional information about the prostate; the minimum functional information includes T2-weighted, diffusion-weighted imaging and dynamic contrast enhanced imaging)
phosphodiesterase type 5
prostate-specific antigen
(transrectal ultrasound guided biopsy; this is where core biopsies of the prostate are taken via the rectum under local anaesthetic)

Paths in this pathway

Pathway created: October 2011 Last updated: May 2019

© NICE 2019. All rights reserved. Subject to Notice of rights.

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