NICE 2019 Guidelines on diagnosis and management of Prostate cancer released

Written by Hina Zahid Published On 2019-07-18T19:00:00+05:30 | Updated On 13 Aug 2021 2:50 PM IST

NICE has released its 2019 guidelines on diagnosis and management of Prostate cancer.

Following are the major recommendations:

2. Assessment and diagnosis

Magnetic resonance imaging and biopsy

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 table 1). If a person opts to have a biopsy, offer systematic prostate biopsy. [2019]

Table 1 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, transrectal ultrasound-guided (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).

Do not offer mapping transperineal template biopsy as part of an initial assessment, unless as part of a clinical trial. [2019]

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 origin)

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 digital rectal examination. [2014]

If the MRI or biopsy is negative

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 ng/ml/ml or PSA velocity greater than 0.75 ng/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 ng/ml/ml) or velocity (0.75 ng/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 ng/ml/ml or PSA velocity greater than 0.75 ng/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 ng/ml/ml) or velocity (0.75 ng/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]

Staging

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]

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 2) to all newly diagnosed people with localised prostate cancer. [2008]

Table 2 Risk stratification for people with localised prostate cancer

Level of risk	PSA		Gleason score		Clinical stage
Low risk	<10 ng/ml	and	≤6	and	T1 to T2a
Intermediate risk	10–20 ng/ml	or	7	or	T2b
High risk¹	>20 ng/ml	or	8–10	or	≥T2c
Abbreviation: PSA, prostate-specific antigen. ¹ High-risk localised prostate cancer is also included in the definition of locally advanced prostate cancer.

Do not routinely offer isotope bone scans to people with low-risk localised prostate cancer. [2008]

3. Localised and locally advanced prostate cancer

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]

Low-risk localised prostate cancer

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. Use table 3 to discuss the benefits and harms with them. [2019]

Table 3 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: active surveillance^a radical prostatectomy radical radiotherapy.
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 progression^b?	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 prostate-specific antigen (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.

Multiparametric MRI and protocol for active surveillance

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 4 for people who have chosen active surveillance. [2019]

Table 4 Protocol for active surveillance

Timing	Tests ^a
Year 1 of active surveillance	Every 3 to 4 months: measure prostate-specific antigen (PSA)^b Throughout active surveillance: monitor PSA kinetics^c At 12 months: digital rectal examination (DRE)^d At 12 to 18 months: multiparametric MRI
Year 2 and every year thereafter until active surveillance ends	Every 6 months: measure PSA^b Throughout active surveillance: monitor PSA kinetics^c Every 12 months: DRE^d
^a If there is concern about clinical or PSA changes at any time during active surveillance, reassess with multiparametric MRI and/or re‑biopsy. ^b Could be carried out in primary care if there are agreed shared-care protocols and recall systems. ^c Could include PSA density and velocity. ^d Should be performed 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.

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]

Intermediate-risk localised prostate cancer

For people with intermediate-risk localised prostate cancer:

offer radical prostatectomy or radical radiotherapy and

consider active surveillance for people who choose not to have immediate radical treatment.Use table 3 to discuss the benefits and harms of each option. [2019]

High-risk localised prostate cancer

Do not offer active surveillance to people with high-risk localised prostate cancer. [2019]

Offer radical prostatectomy or radical radiotherapy to people with high-risk localised prostate cancer when it is likely the person's cancer can be controlled in the long term. [2019]

Radical treatment

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 intermediate- and high-risk localised prostate cancer a combination of radical radiotherapy and androgen deprivation therapy, rather than radical radiotherapy or androgen deprivation therapy alone. [2014]

Offer people with intermediate- and high-risk localised prostate cancer 6 months of androgen deprivation therapy before, during or after radical external beam radiotherapy. [2014]

Consider continuing androgen deprivation therapy for up to 3 years for people with high-risk localised prostate cancer, and discuss the benefits and risks of this option with them. [2014]

Consider brachytherapy in combination with external beam radiotherapy for people with intermediate- and high-risk localised prostate cancer. [2019]

Do not offer brachytherapy alone to people with high-risk localised prostate cancer. [2008]

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 ng/ml.Explain the benefits and harms (see table 5) and make a shared decision about whether the person should have this treatment. [2019]

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 intervention. [2008]

Table 5 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^a, 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.
^a James 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.

Watchful waiting

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]

Locally advanced prostate cancer

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]

Do not offer immediate post-operative radiotherapy after radical prostatectomy, even to people with the 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]

Do not offer bisphosphonates for the prevention of bone metastases in people with prostate cancer. [2008]

Managing adverse effects of radical treatment

Sexual dysfunction

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]

Urinary incontinence

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]

Radiation-induced enteropathy

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]

Follow-up for people with localised or locally advanced prostate cancer having radical treatment or on watchful waiting

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 digital rectal examination 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]

Managing relapse 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]

4. People having hormone therapy

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 ng/ml or above, or if there is symptomatic progression. [2014]

Managing adverse effects of hormone therapy

Hot flushes

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]

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]

Sexual dysfunction

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]

Osteoporosis

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]

Gynaecomastia

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]

Fatigue

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]

5. Metastatic prostate cancer

Information and support

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]

Treatment

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]

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]

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]

Hormone-relapsed metastatic prostate cancer

Recommendations in this section marked with an asterisk (*) 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, see the NICE technology appraisal guidance on:

abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen

enzalutamide for metastatic hormone-relapsed prostate cancer previously treated with a docetaxel-containing regimen. [2019]

Bone-targeted therapies

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 guidance on treatments for people with bone metastases from prostate cancer, see the NICE technology appraisal guidance on radium-223 dichloride. [2019]

Pelvic-targeted therapies

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]

For more details click on the link: www.nice.org.uk

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Hina Zahid