People have the right to be involved in discussions and make informed decisions about their care, as described in NICE's information on making decisions about 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.
For advice on communication and patient-centred care throughout the patient journey, follow the recommendations in the NICE guidelines on patient experience in adult NHS services and improving supportive and palliative care for adults with cancer. [2008]
Offer people with prostate cancer information tailored to their own needs. This information should be given by a healthcare professional (for example, a consultant or specialist nurse) and may be supported by written and visual media. [2008]
Offer people with prostate cancer advice on how to get information and support from websites, local and national cancer information services, and from cancer support groups. [2008]
Choose or recommend information resources for people with prostate cancer that are clear, reliable and up to date. Ask for feedback from people with prostate cancer and their partners or carers to identify the highest quality information resources. [2008]
Find out the extent to which the person wishes to be involved in their decision making, and ensure that they have sufficient information to do so. [2008]
Use an up-to-date decision aid in all urological cancer multidisciplinary teams (MDTs). Healthcare professionals trained in its use should offer it to people with localised prostate cancer when making treatment decisions. [2008]
Use nomograms together with people with prostate cancer to help:
with decision making
predict biopsy results
predict pathological stage
predict risk of treatment failure. [2008]
Explain the reliability, validity and limitations of any predictions made using nomograms. [2008]
Discuss all relevant management options in this guideline with people with prostate cancer and their partners or carers, even if they are not available through their local services. [2008]
Tell people with prostate cancer:
about treatment options and their risks and benefits in an objective, unbiased manner and
that there is limited evidence for some treatment options. [2014]
Ensure that mechanisms are in place so people with prostate cancer and their primary care providers have access to specialist services throughout the course of their disease. [2008]
Tell people with prostate cancer and their partners or carers about the effects of prostate cancer and the treatment options on their:
sexual function
physical appearance
continence
other aspects of masculinity.
Support people and their partners or carers in making treatment decisions, taking into account the effects on quality of life as well as survival. [2008]
Offer people with prostate cancer, and their partners or carers, the opportunity to talk to a healthcare professional experienced in dealing with psychosexual issues at any stage of the condition and its treatment. [2008]
Do not routinely offer multiparametric MRI to people with prostate cancer who are not going to be able to have radical treatment. [2019]
Offer multiparametric MRI as the first-line investigation for people with suspected clinically localised prostate cancer. Report the results using a 5‑point Likert scale. [2019]
Offer multiparametric MRI-influenced prostate biopsy to people whose Likert score is 3 or more. [2019]
Consider omitting a prostate biopsy for people whose multiparametric MRI Likert score is 1 or 2, but only after discussing the risks and benefits with the person and reaching a shared decision (see box 1). If a person opts to have a biopsy, offer systematic prostate biopsy. [2019]
There is more than 1 type of prostate biopsy. The most common approach is transrectal ultrasound-guided (TRUS) biopsy. The data in box 1 comes from the PROMIS and ProtecT studies, which used TRUS. There is no equivalent data for other types of biopsy. The ranges given in box 1 reflect different definitions of clinically significant prostate cancer (UCL1 and UCL2; see PROMIS publications).
Box 1 Factors to consider when discussing the options for people whose multiparametric MRI Likert score is 1 or 2
Advantages 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.
Disadvantages of undergoing prostate biopsy
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, transrectal ultrasound-guided (TRUS), has some rare but important complications. The most serious is sepsis, which develops in a bit fewer 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 fewer 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.
Do not offer mapping transperineal template biopsy as part of an initial assessment, unless as part of a clinical trial. [2019]
For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on MRI and biopsy.
Full details of the evidence and the committee's discussion are in evidence review D: diagnosing and identifying clinically significant prostate cancer.
Help people decide whether to have an MRI or prostate biopsy by discussing:
their prostate-specific antigen (PSA) level
their digital rectal examination (DRE) findings (including an estimate of prostate size)
any comorbidities, together with their risk factors (including increasing age and black African–Caribbean family background)
any history of a previous negative prostate biopsy.
Do not automatically offer a prostate biopsy on the basis of serum PSA level alone. [2008]
Give people and their partners or carers information, support and adequate time to decide whether or not they wish to have an MRI or prostate biopsy. Explain the risks (including the increased chance of having to live with the diagnosis of clinically insignificant prostate cancer) and benefits. [2008]
If the clinical suspicion of prostate cancer is high, because of a high PSA value and evidence of bone metastases (identified by a positive isotope bone scan or sclerotic metastases on plain radiographs), do not offer prostate biopsy for histological confirmation unless this is needed as part of a clinical trial. [2008]
Have a core member of the urological cancer MDT review the risk factors of all people who have had a negative first prostate biopsy. Discuss with the person that:
there is still a risk that prostate cancer is present and
the risk is slightly higher if any of the following risk factors are present:
the biopsy showed high-grade prostatic intra-epithelial neoplasia (HGPIN)
the biopsy showed atypical small acinar proliferation (ASAP)
abnormal DRE. [2014]
For people with a negative biopsy who have an MRI Likert score of 3 or more, discuss the possibility of significant disease in an MDT meeting with a view to repeating the prostate biopsy. [2019]
For people who have a raised PSA and MRI Likert score of 1 or 2, and who have not had a prostate biopsy, repeat PSA test at 3 to 6 months and:
offer prostate biopsy if there is a strong suspicion of prostate cancer (for example, PSA density greater than 0.15 nanogram/ml/ml or PSA velocity greater than 0.75 nanogram/ml/year, or strong family history), taking into account their life expectancy and comorbidities
discharge the person to primary care if the level of suspicion is low; advise PSA follow up at 6 months and then every year, and set a PSA level for primary care at which to re‑refer based on PSA density (0.15 nanogram/ml/ml) or velocity (0.75 nanogram/ml/year). [2019]
For people who have a raised PSA, an MRI Likert score of 1 or 2 (or a contraindication to MRI), and negative biopsy, repeat PSA at 3 to 6 months and:
offer prostate biopsy if there is a strong suspicion of prostate cancer (for example, PSA density greater than 0.15 nanogram/ml/ml or PSA velocity greater than 0.75 nanogram/ml/year, or strong family history), taking into account their life expectancy and comorbidities
discharge the person to primary care if the level of suspicion is low; advise PSA follow up every 2 years, and set a PSA level for primary care at which to re‑refer, based on PSA density (0.15 nanogram/ml/ml) or velocity (0.75 nanogram/ml/year). [2019]
The PROGENSA PCA3 assay and the Prostate Health Index is not recommended in people having investigations for suspected prostate cancer who have had a negative or inconclusive prostate biopsy. [2019]
For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on if the MRI or biopsy is negative.
Full details of the evidence and the committee's discussion are in evidence review E: following up people at risk of prostate cancer.
Consider CT for people with histologically proven prostate cancer for whom MRI is contraindicated if knowledge of the T or N stage could affect management. [2014]
Urological cancer MDTs should assign a risk category (see table 1) to all people with newly diagnosed localised or locally advanced prostate cancer. [2021]
| Cambridge Prognostic Group | Criteria |
|---|---|
|
1 |
Gleason score 6 (grade group 1)
and
and |
|
2 |
Gleason score 3 + 4 = 7 (grade group 2) or PSA 10 microgram/litre to 20 microgram/litre |
|
3 |
Gleason score 3 + 4 = 7 (grade group 2) and PSA 10 microgram/litre to 20 microgram/litre and Stages T1–T2 |
|
4 |
One of: Gleason score 8 (grade group 4), PSA more than 20 microgram/litre, Stage T3 |
|
5 |
Two or more of: Gleason score 8 (grade group 4), PSA more than 20 microgram/litre, Stage T3 |
For a short explanation of why the committee made this recommendation and how it might affect practice, see the rationale and impact section on risk stratification for localised or locally advanced prostate cancer
Full details of the evidence and the committee's discussion are in evidence review I: risk stratification for localised prostate cancer.
Do not routinely offer isotope bone scans to people with Cambridge Prognostic Group (CPG) 1 or 2 localised prostate cancer. [2008, amended 2021]
For a short explanation of how the committee amended this recommendation to take into account the 5‑tier CPG risk model and how it might affect practice, see the rationale and impact section on bone scans for newly diagnosed prostate cancer.
Full details of the committee's discussion on how the recommendations were amended to take into account the 5‑tier CPG risk model are in evidence review I: risk stratification for localised prostate cancer.
Offer isotope bone scans when hormonal therapy is being deferred as part of watchful waiting to asymptomatic people who are at high risk of developing bone complications. [2008]
Before radical treatment, explain to people and, if they wish, their partner, that radical treatment for prostate cancer will result in an alteration of sexual experience, and may result in loss of sexual function. [2008, amended 2014]
Explain to people and, if they wish, their partner, about the potential loss of ejaculation and fertility associated with radical treatment for prostate cancer. Offer sperm storage. [2008, amended 2014]
Warn people undergoing radical treatment for prostate cancer of the likely effects of the treatment on their urinary function. [2008, amended 2014]
Offer a urological assessment to people who have troublesome urinary symptoms before treatment. [2008]
People with prostate cancer who are candidates for radical treatment should have the opportunity to discuss the range of treatment modalities and their serious side effects in relation to their treatment options with a specialist surgical oncologist and a specialist clinical oncologist. [2008]
Explain to people that there is a small increase in the risk of colorectal cancer after radical external beam radiotherapy for prostate cancer. [2014]
When discussing treatment options with people with CPG 1, 2 and 3 localised prostate cancer, use box 2 to discuss the benefits and harms with them and refer to the NICE guideline on shared decision making. [2019, amended 2021]
Box 2 Factors to consider when discussing active surveillance, radical prostatectomy or radical radiotherapy as treatment options for people with CPG 1, 2 and 3 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:
active surveillance (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)
radical prostatectomy
radical radiotherapy.
What effect does each treatment option have on survival at 10 years?
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 progression at 10 years?
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.
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 prostate-specific antigen (PSA) of more than 20% between consecutive measures at any time during follow up or
any rise in PSA level of 50% or more in any 12‑month period confirmed by repeat tests or
any indication of the appearance of symptomatic systemic disease.
What effect does each treatment option have on the rate of development of distant metastases at 10 years?
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.
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.
At 6 months, problems with urinary continence 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 with urinary continence 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.
At 6 months, moderate to severe urinary incontinence 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, moderate to severe urinary incontinence 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.
At 6 months, moderate or severe problems with erectile dysfunction 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, moderate or severe problems with erectile dysfunction 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.
At 6 months, problems with faecal incontinence more than once per week 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 with faecal incontinence more than once per week 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.
At 6 months, moderate to severe impact of bowel habits on quality of life 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, moderate to severe impact of bowel habits on quality of life 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.
For people with CPG 1 localised prostate cancer:
offer active surveillance
consider radical prostatectomy or radical radiotherapy if active surveillance is not suitable or acceptable to the person. [2019, amended 2021]
For people with CPG 2 localised prostate cancer, offer a choice between active surveillance, radical prostatectomy or radical radiotherapy if radical treatment is suitable. [2019, amended 2021]
For people with CPG 3 localised prostate cancer:
offer radical prostatectomy or radical radiotherapy and
consider active surveillance (in line with recommendation 1.3.14) for people who choose not to have immediate radical treatment. [2019, amended 2021]
Do not offer active surveillance to people with CPG 4 and 5 localised and locally advanced prostate cancer. [2019, amended 2021]
Offer radical prostatectomy or radical radiotherapy to people with CPG 4 and 5 localised and locally advanced prostate cancer when it is likely the person's cancer can be controlled in the long term. [2019, amended 2021]
For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on treatment options for localised and locally advanced prostate cancer.
Full details of the evidence and the committee's discussion are in evidence review G: active surveillance, radical prostatectomy or radical radiotherapy in people with localised prostate cancer. Full details of the committee's discussion on how the recommendations were amended to take into account the 5‑tier CPG risk model are in evidence review I: risk stratification for localised prostate cancer.
Offer multiparametric MRI to people having active surveillance who have not had an MRI previously. If the MRI results do not agree with the biopsy findings, offer a new MRI-influenced biopsy. [2019]
Consider using the protocol in table 2 for people who have chosen active surveillance. [2019]
| Timing | Tests (if there is concern about clinical or prostate-specific antigen changes at any time during active surveillance, reassess with multiparametric MRI and/or re‑biopsy) |
|---|---|
|
Year 1 of active surveillance |
Every 3 to 4 months: measure prostate-specific antigen (PSA; could be carried out in primary care if there are agreed shared-care protocols and recall systems) Throughout active surveillance: monitor PSA kinetics (could include PSA density and velocity) At 12 months: digital rectal examination (DRE; should be done by a healthcare professional with expertise and confidence in performing DRE. In a large UK trial that informed this protocol, DREs were carried out by a urologist or a nurse specialist) At 12 to 18 months: multiparametric MRI |
|
Year 2 and every year thereafter until active surveillance ends |
Every 6 months: measure PSA (could be carried out in primary care if there are agreed shared-care protocols and recall systems) Throughout active surveillance: monitor PSA kinetics (could include PSA density and velocity) Every 12 months: DRE (should be done by a healthcare professional with expertise and confidence in performing DRE. In a large UK trial that informed this protocol, DREs were carried out by a urologist or a nurse specialist) |
For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on multiparametric MRI for active surveillance.
Full details of the evidence and the committee's discussion are in evidence review F: identifying prostate cancer clinical progression in people with low- to intermediate-risk cancer.
If a person wishes to move from active surveillance to radical treatment at any stage in their care, make a shared decision to do so based on the person's preferences, comorbidities and life expectancy. [2019]
Offer radical treatment to people with localised prostate cancer who had chosen an active surveillance regimen and who now have evidence of disease progression. [2019]
Commissioners of urology services should consider providing robotic surgery to treat localised prostate cancer. [2014]
Commissioners should base robotic systems for the surgical treatment of localised prostate cancer in centres that are expected to perform at least 150 robot-assisted laparoscopic radical prostatectomies per year to ensure they are cost effective. [2014]
For people having radical external beam radiotherapy for localised prostate cancer:
offer hypofractionated radiotherapy (60 Gy in 20 fractions) using image-guided intensity modulated radiation therapy (IMRT), unless contraindicated or
offer conventional radiotherapy (74 Gy in 37 fractions) to people who cannot have hypofractionated radiotherapy. [2019]
Offer people with localised and locally advanced prostate cancer receiving radical external beam radiotherapy with curative intent planned treatment techniques that optimise the dose to the tumour while minimising the risks of normal tissue damage. [2008]
Offer people with CPG 2, 3, 4 and 5 localised or locally advanced prostate cancer a combination of radical radiotherapy and androgen deprivation therapy, rather than radical radiotherapy or androgen deprivation therapy alone. [2014, amended 2021]
Offer people with CPG 2, 3, 4 and 5 localised or locally advanced prostate cancer 6 months of androgen deprivation therapy before, during or after radical external beam radiotherapy. [2014, amended 2021]
Consider continuing androgen deprivation therapy for up to 3 years for people with CPG 4 and 5 localised or locally advanced prostate cancer, and discuss the benefits and risks of this option with them. [2014, amended 2021]
Consider brachytherapy in combination with external beam radiotherapy for people with CPG 2, 3, 4 and 5 localised or locally advanced prostate cancer. [2019, amended 2021]
Do not offer brachytherapy alone to people with CPG 4 and 5 localised or locally advanced prostate cancer. [2008, amended 2021]
For a short explanation of why the committee made the recommendations on radiotherapy and how they might affect practice, see the rationale and impact section on radiotherapy.
Full details of the evidence and the committee's discussion are in evidence review C: radical radiotherapy. Full details of the committee's discussion on how the recommendations were amended to take into account the 5-tier CPG risk model are in evidence review I: risk stratification for localised prostate cancer.
Discuss the option of docetaxel chemotherapy with people who have newly diagnosed non‑metastatic prostate cancer who:
are starting long-term androgen deprivation therapy and
have no significant comorbidities and
have high-risk disease, as shown by:
T3/T4 staging or
Gleason score 8 to 10 or
PSA greater than 40 microgram/litre.
Explain the benefits and harms (see box 3) and make a shared decision about whether the person should have this treatment. [2019]
In May 2019, this was an off-label use of docetaxel. See NICE's guidance on prescribing medicines for further information.
For people having docetaxel chemotherapy:
start treatment within 12 weeks of starting androgen deprivation therapy
use six 3‑weekly cycles at a dose of 75 mg/m2 (with or without daily prednisolone). [2019]
Do not offer high-intensity focused ultrasound and cryotherapy to people with localised prostate cancer, other than in the context of controlled clinical trials comparing their use with established interventions. [2008]
NICE's interventional procedures guidance on high-intensity focused ultrasound for prostate cancer, cryotherapy for recurrent prostate cancer and cryotherapy as a primary treatment for prostate cancer evaluated the safety and efficacy of cryotherapy and high-intensity focused ultrasound for the treatment of prostate cancer. NICE guidelines provide guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. Because there was a lack of evidence on quality-of-life benefits and long-term survival, these interventions are not recommended in this guideline.
NICE's interventional procedures guidance on focal therapy using high-intensity focused ultrasound for localised prostate cancer and focal therapy using cryoablation for localised prostate cancer found no major safety concerns, but evidence on efficacy is limited in quantity and there is a concern that prostate cancer is commonly multifocal.
Box 3 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 trial (James et al. 2016), 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 with 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.
For a short explanation of why the committee made the recommendations on docetaxel chemotherapy and how they might affect practice, see the rationale and impact section on docetaxel chemotherapy.
Full details of the evidence and the committee's discussion are in evidence review B: docetaxel in people with hormone-sensitive prostate cancer.
People with localised prostate cancer who have chosen watchful waiting and who have evidence of significant disease progression (that is, rapidly rising PSA level or bone pain) should have their situation reviewed by a member of the urological cancer MDT. [2008]
Consider pelvic radiotherapy for people with locally advanced prostate cancer who have a higher than 15% risk of pelvic lymph node involvement and who are to receive neoadjuvant hormonal therapy and radical radiotherapy. [2008]
Risk of pelvic node lymph involvement estimated using the Roach formula: %LN risk = 2/3 PSA + (10 × [Gleason score - 6]).
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. [2008]
Do not offer adjuvant hormonal therapy in addition to radical prostatectomy, even to people with margin-positive disease, other than in the context of a clinical trial. [2008]
Do not offer high-intensity focused ultrasound and cryotherapy to people with locally advanced prostate cancer other than in the context of controlled clinical trials comparing their use with established interventions. [2008]
NICE's interventional procedures guidance on high-intensity focused ultrasound for prostate cancer, cryotherapy for recurrent prostate cancer and cryotherapy as a primary treatment for prostate cancer evaluated the safety and efficacy of cryotherapy and high-intensity focused ultrasound for the treatment of prostate cancer. NICE guidelines provide guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. Because there was a lack of evidence on quality-of-life benefits and long-term survival, these interventions are not recommended in this guideline.
Do not offer bisphosphonates for the prevention of bone metastases in people with prostate cancer. [2008]
Offer people who have had radical treatment for prostate cancer access to specialist erectile dysfunction services. [2008, amended 2014]
Offer people with prostate cancer who experience loss of erectile function phosphodiesterase type 5 (PDE5) inhibitors to improve their chance of spontaneous erections. [2008]
If PDE5 inhibitors do not restore erectile function or are contraindicated, offer people vacuum devices, intraurethral inserts or penile injections, or penile prostheses as an alternative. [2008]
Ensure that people with prostate cancer who have troublesome urinary symptoms after treatment have access to specialist continence services for assessment, diagnosis and conservative treatment. This could include coping strategies, pelvic floor muscle re-education, bladder retraining and pharmacotherapy. [2008]
Refer people with prostate cancer who have intractable stress incontinence to a specialist surgeon for consideration of an artificial urinary sphincter. [2008]
Do not offer injection of bulking agents into the distal urinary sphincter to treat stress incontinence in people with prostate cancer. [2008]
Offer people with signs or symptoms of radiation-induced enteropathy care from a team of professionals with expertise in radiation-induced enteropathy (who may include oncologists, gastroenterologists, bowel surgeons, dietitians and specialist nurses). [2014]
Include the nature and treatment of radiation-induced enteropathy in training programmes for oncologists and gastroenterologists. [2014]
Carry out full investigations, including flexible sigmoidoscopy, in people who have symptoms of radiation-induced enteropathy to exclude inflammatory bowel disease or malignancy of the large bowel and to ascertain the nature of the radiation injury. Use caution when performing anterior wall rectal biopsy after brachytherapy because of the risk of fistulation. [2014]
A urologist or specialist nurse should discuss the purpose, duration, frequency and location of follow up with each person with localised and locally advanced prostate cancer, and if they wish, their partner or carers. [2019]
A urologist or specialist nurse should advise people with prostate cancer about potential longer‑term adverse effects of treatment and when and how to report them. [2019]
Check PSA levels for all people with prostate cancer who are having radical treatment no earlier than 6 weeks after treatment, at least every 6 months for the first 2 years, and then at least once a year after that. [2019]
Do not routinely offer DRE to people with localised prostate cancer who are not on active surveillance while their PSA remains at baseline levels. [2019]
After at least 6 months' initial follow up, consider a remote follow‑up strategy for people with a stable PSA who have had no significant treatment complications, unless they are taking part in a clinical trial that needs formal clinic-based follow up. [2019]
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. [2019]
For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on follow up.
Full details of the evidence and the committee's discussion are in evidence review H: follow-up protocols after radical treatment.
Analyse serial PSA levels after radical treatment using the same assay technique as used before. [2008]
Do not offer biopsy of the prostatic bed to people with prostate cancer who have had a radical prostatectomy. [2008]
Only offer biopsy of the prostate after radiotherapy to people with prostate cancer who might have local salvage therapy in the context of a clinical trial. [2008]
For people with evidence of biochemical relapse after radical treatment who are thinking about having radical salvage therapy:
do not offer routine MRI scanning before salvage radiotherapy in people with prostate cancer
offer an isotope bone scan if symptoms or PSA trends are suggestive of metastases. [2008]
Take into account that biochemical relapse (a rising PSA) alone should not mean an immediate change in treatment is needed. [2008]
Estimate PSA doubling time if biochemical relapse occurs. Base this on a minimum of 3 measurements over at least a 6‑month period. [2008]
Offer people with biochemical relapse after radical prostatectomy, with no known metastases, radical radiotherapy to the prostatic bed. [2008]
Consider entry to appropriate clinical trials for people with biochemical relapse. [2008]
Do not routinely offer hormonal therapy to people with prostate cancer who have a biochemical relapse unless they have:
symptomatic local disease progression or
any proven metastases or
a PSA doubling time of less than 3 months. [2008]
Consider intermittent therapy for people having long-term androgen deprivation therapy (not in the adjuvant setting). Discuss with the person (and their partner, family or carers if they wish):
the rationale for intermittent therapy
the limited evidence for reduction in side effects from intermittent therapy
the effect of intermittent therapy on progression of prostate cancer. [2014]
For people who are having intermittent androgen deprivation therapy:
measure PSA every 3 months and
restart androgen deprivation therapy if PSA is 10 nanogram/ml or above, or if there is symptomatic progression. [2014]
Offer medroxyprogesterone (20 mg per day), initially for 10 weeks, to manage troublesome hot flushes caused by long-term androgen suppression. Evaluate the effect at the end of the treatment period. [2014]
In May 2019, this was an off-label use of medroxyprogesterone. See NICE's guidance on prescribing medicines for further information.
Consider cyproterone acetate (50 mg twice a day for 4 weeks) to treat troublesome hot flushes if medroxyprogesterone is not effective or not tolerated. [2014]
Tell people that there is no good-quality evidence for the use of complementary therapies to treat troublesome hot flushes. [2014]
Before they start androgen deprivation therapy, tell people and, if they wish, their partner, that long-term androgen deprivation will cause a reduction in libido and possible loss of sexual function. [2014]
Advise people and, if they wish, their partner, about the potential loss of ejaculation and fertility associated with long-term androgen deprivation and offer sperm storage. [2014]
Ensure that people starting androgen deprivation therapy have access to specialist erectile dysfunction services. [2014]
Consider referring people who are having long-term androgen deprivation therapy, and their partners, for psychosexual counselling. [2014]
Offer PDE5 inhibitors to people having long-term androgen deprivation therapy who experience loss of erectile function. [2014]
If PDE5 inhibitors fail to restore erectile function or are contraindicated, offer a choice of:
intraurethral inserts
penile injections
penile prostheses
vacuum devices. [2014]
Do not routinely offer bisphosphonates to prevent osteoporosis in people with prostate cancer having androgen deprivation therapy. [2008]
Consider assessing fracture risk in people with prostate cancer who are having androgen deprivation therapy, in line with the NICE guideline on osteoporosis: assessing the risk of fragility fracture. [2014]
Offer bisphosphonates to people who are having androgen deprivation therapy and have osteoporosis. [2014]
Consider denosumab for people who are having androgen deprivation therapy and have osteoporosis if bisphosphonates are contraindicated or not tolerated. [2014]
For people starting long-term bicalutamide monotherapy (longer than 6 months), offer prophylactic radiotherapy to both breast buds within the first month of treatment. Use a single fraction of 8 Gy using orthovoltage, or electron beam radiotherapy. [2008]
If radiotherapy does not prevent gynaecomastia, consider weekly tamoxifen. [2008]
In May 2019, this was an off-label use of tamoxifen. See NICE's guidance on prescribing medicines for further information.
Tell people who are starting androgen deprivation therapy that fatigue is a recognised side effect of this therapy, and might not be because of their prostate cancer. [2014]
Offer people who are starting or having androgen deprivation therapy supervised resistance and aerobic exercise at least twice a week for 12 weeks to reduce fatigue and improve quality of life. [2014]
Offer people with metastatic prostate cancer tailored information and access to specialist urology and palliative care teams to address their specific needs. Give them the opportunity to discuss any significant changes in their disease status or symptoms as these occur. [2008]
Integrate palliative interventions at any stage into coordinated care, and facilitate any transitions between care settings as smoothly as possible. [2008]
Discuss personal preferences for palliative care as early as possible with people with metastatic prostate cancer, their partners and carers. Tailor treatment/care plans accordingly, and identify the preferred place of care. [2008]
Ensure that palliative care is available when needed and is not limited to the end of life. Care should not be restricted to being associated with hospice care. [2008]
Offer a regular assessment of needs to people with metastatic prostate cancer. [2008]
Offer docetaxel chemotherapy to people with newly diagnosed metastatic prostate cancer who do not have significant comorbidities as follows:
start treatment within 12 weeks of starting androgen deprivation therapy and
use six 3‑weekly cycles at a dose of 75 mg/m2 (with or without daily prednisolone). [2019]
In May 2019, this was an off-label use of docetaxel. See NICE's guidance on prescribing medicines for further information.
For a short explanation of why the committee made these recommendations and how they might affect practice, see rationale and impact section on docetaxel chemotherapy.
Full details of the evidence and the committee's discussion are in evidence review B: docetaxel in people with hormone-sensitive prostate cancer.
Offer bilateral orchidectomy to all people with metastatic prostate cancer as an alternative to continuous luteinising hormone-releasing hormone agonist therapy. [2008]
Do not offer combined androgen blockade as a first-line treatment for people with metastatic prostate cancer. [2008]
For people with metastatic prostate cancer who are willing to accept the adverse impact on overall survival and gynaecomastia with the aim of retaining sexual function, offer anti-androgen monotherapy with bicalutamide (150 mg). [2008]
In May 2019, this was an off-label use of bicalutamide. See NICE's information on prescribing medicines for further information.
Begin androgen deprivation therapy and stop bicalutamide treatment in people with metastatic prostate cancer who are taking bicalutamide monotherapy and who do not maintain satisfactory sexual function. [2008]
Recommendations 1.5.12, 1.5.13 and 1.5.14 are from the NICE technology appraisal guidance on docetaxel for the treatment of hormone-refractory metastatic prostate cancer.
Discuss the treatment options for people with prostate cancer who develop biochemical evidence of hormone-relapsed disease at the urological cancer MDT. Seek an oncologist and/or specialist palliative care opinion, as appropriate. [2008]
Docetaxel is recommended, within its licensed indications, as a treatment option for people with hormone-refractory prostate cancer only if their Karnofsky Performance-Status score is 60% or more. [2008]
It is recommended that treatment with docetaxel should be stopped:
at the completion of planned treatment of up to 10 cycles or
if severe adverse events occur or
in the presence of progression of disease as evidenced by clinical or laboratory criteria, or by imaging studies. [2008]
Repeat cycles of treatment with docetaxel are not recommended if the disease recurs after completion of the planned course of chemotherapy. [2008]
Offer a corticosteroid such as dexamethasone (0.5 mg daily) as third-line hormonal therapy after androgen deprivation therapy and anti-androgen therapy to people with hormone-relapsed prostate cancer. [2008]
Offer spinal MRI to people with hormone-relapsed prostate cancer shown to have extensive metastases in the spine (for example, on a bone scan) if they develop any spinal-related symptoms. [2008]
Do not routinely offer spinal MRI to all people with hormone-relapsed prostate cancer and known bone metastases. [2008]
For advice on treatments for metastatic hormone-relapsed prostate cancer previously treated with docetaxel, including genomic biomarker-based treatment, see the NICE technology appraisal guidance on our topic page on prostate cancer. The point at which to use genomic biomarker-based therapy in solid tumour treatment pathways is uncertain. [2019]
For people with hormone-relapsed metastatic prostate cancer, consider zoledronic acid to prevent or reduce skeletal-related events. [2019]
Consider oral or intravenous bisphosphonates for pain relief for people with hormone-relapsed metastatic prostate cancer when other treatments, including analgesics and palliative radiotherapy, have not given satisfactory pain relief. [2019]
For NICE technology appraisal guidance on treatments for people with bone metastases from prostate cancer, see the NICE technology appraisal guidance on our topic page on prostate cancer. [2019]
For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on bone-targeted therapies (bisphosphonates).
Full details of the evidence and the committee's discussion are in evidence review A: bisphosphonates.
Offer decompression of the upper urinary tract by percutaneous nephrostomy or by insertion of a double J stent to people with obstructive uropathy secondary to hormone-relapsed prostate cancer. [2008]
Discuss the option of no intervention as a treatment choice with people with obstructive uropathy secondary to hormone-relapsed prostate cancer. [2008]
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.
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.
This refers to the 2019 International Society of Urological Pathology grade groupings for prostate cancer.
Refers to prostate cancer after failure of primary androgen deprivation therapy.
For the purposes of this guideline, this includes T3 and T4 prostate cancer.
Cancer that has been staged as T1 or T2 (confined to the prostate gland).
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.
The information from the multiparametric MRI 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 multiparametric MRI will be ultrasound-guided, but the specific area(s) targeted will be predetermined by the multiparametric MRI data.
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 done by an open approach or by keyhole technique (laparoscopic or robotically assisted laparoscopic prostatectomy).
A template biopsy is normally done 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 when 20 sites are systematically sampled, with 2 or 3 cores per site, sometimes meaning over 50 core biopsies are taken.
This is sampling 6 or 8 sites from the prostate using a transperineal route under local anaesthetic.
This is when core biopsies of the prostate are taken via the rectum under local anaesthetic.
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.
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.