Information

1.1.1.

For advice on communication and patient-centred care throughout the patient journey, follow the recommendations in the NICE guidelines on improving outcomes in urological cancers and improving supportive and palliative care for adults with cancer. [2008]

1.1.2.

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]

1.1.3.

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]

1.1.4.

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]

Decision support

1.1.5.

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]

1.1.6.

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]

1.1.7.

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]

1.1.8.

Explain the reliability, validity and limitations of any predictions made using nomograms. [2008]

1.1.9.

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]

1.1.10.

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]

1.1.11.

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]

1.1.12.

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]

1.1.13.

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]

MRI and biopsy

1.2.1.

Do not routinely offer multiparametric MRI to people with prostate cancer who are not going to be able to have radical treatment. [2019]

1.2.2.

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]

1.2.3.

Offer multiparametric MRI-influenced prostate biopsy to people whose Likert score is 3 or more. [2019]

1.2.4.

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).

1.2.5.

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

1.2.6.

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]

1.2.7.

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]

1.2.8.

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]

1.2.9.

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]

If the MRI or biopsy is negative

1.2.10.

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]

1.2.11.

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]

1.2.12.

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]

1.2.13.

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

Risk stratification for localised or locally advanced prostate cancer

1.2.15.

Urological cancer MDTs should assign a risk category (see table 1) to all people with newly diagnosed localised or locally advanced prostate cancer. [2021]

Table 1

Risk stratification for people with localised or locally advanced prostate cancer.

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.

Treatment options for localised and locally advanced prostate cancer

1.3.7.

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]

1.3.8.

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]

1.3.9.

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]

1.3.10.

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]

1.3.11.

Do not offer active surveillance to people with CPG 4 and 5 localised and locally advanced prostate cancer. [2019, amended 2021]

1.3.12.

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]

Multiparametric MRI and protocol for active surveillance

1.3.13.

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]

1.3.14.

Consider using the protocol in table 2 for people who have chosen active surveillance. [2019]

Table 2

Protocol for active surveillance.

1.3.15.

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]

1.3.16.

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]

Radical treatment

1.3.17.

Commissioners of urology services should consider providing robotic surgery to treat localised prostate cancer. [2014]

1.3.18.

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]

1.3.19.

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]

1.3.20.

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]

1.3.21.

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]

1.3.22.

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]

1.3.23.

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]

1.3.24.

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]

1.3.25.

Do not offer brachytherapy alone to people with CPG 4 and 5 localised or locally advanced prostate cancer. [2008, amended 2021]

1.3.26.

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.

1.3.27.

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]

1.3.28.

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.

Watchful waiting

1.3.29.

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

1.3.30.

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]

1.3.31.

Risk of pelvic node lymph involvement estimated using the Roach formula: %LN risk = 2/3 PSA + (10 × [Gleason score - 6]).

1.3.32.

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]

1.3.33.

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]

1.3.34.

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.

1.3.35.

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

Managing adverse effects of radical treatment

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

1.3.45.

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]

1.3.46.

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]

1.3.47.

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]

1.3.48.

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]

1.3.49.

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]

1.3.50.

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

1.3.51.

Analyse serial PSA levels after radical treatment using the same assay technique as used before. [2008]

1.3.52.

Do not offer biopsy of the prostatic bed to people with prostate cancer who have had a radical prostatectomy. [2008]

1.3.53.

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]

1.3.54.

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]

1.3.55.

Take into account that biochemical relapse (a rising PSA) alone should not mean an immediate change in treatment is needed. [2008]

1.3.56.

Estimate PSA doubling time if biochemical relapse occurs. Base this on a minimum of 3 measurements over at least a 6-month period. [2008]

1.3.57.

Offer people with biochemical relapse after radical prostatectomy, with no known metastases, radical radiotherapy to the prostatic bed. [2008]

1.3.58.

Consider entry to appropriate clinical trials for people with biochemical relapse. [2008]

1.3.59.

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]

Managing adverse effects of hormone therapy

Information and support

1.5.1.

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]

1.5.2.

Integrate palliative interventions at any stage into coordinated care, and facilitate any transitions between care settings as smoothly as possible. [2008]

1.5.3.

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]

1.5.4.

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]

1.5.5.

Offer a regular assessment of needs to people with metastatic prostate cancer. [2008]

Initial treatment

1.5.6.

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.

1.5.7.

Offer bilateral orchidectomy to all people with metastatic prostate cancer as an alternative to continuous luteinising hormone-releasing hormone agonist therapy. [2008]

1.5.8.

Do not offer combined androgen blockade as a first-line treatment for people with metastatic prostate cancer. [2008]

1.5.9.

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.

1.5.10.

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

1.5.11.

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]

1.5.12.

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]

1.5.13.

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]

1.5.14.

Repeat cycles of treatment with docetaxel are not recommended if the disease recurs after completion of the planned course of chemotherapy. [2008]

1.5.15.

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]

1.5.16.

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]

1.5.17.

Do not routinely offer spinal MRI to all people with hormone-relapsed prostate cancer and known bone metastases. [2008]

1.5.18.

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]

Bone-targeted therapies

1.5.19.

For people with hormone-relapsed metastatic prostate cancer, consider zoledronic acid to prevent or reduce skeletal-related events. [2019]

1.5.20.

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]

1.5.21.

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]

Pelvic-targeted therapies

1.5.22.

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]

1.5.23.

Discuss the option of no intervention as a treatment choice with people with obstructive uropathy secondary to hormone-relapsed prostate cancer. [2008]

1. Follow up during active surveillance

What is the most suitable surveillance protocol (including the role of digital rectal examination [DRE] and prostate-specific antigen [PSA] measures) for people for whom active surveillance is appropriate, as assessed by multiparametric MRI and biopsy, when there are no clinical concerns during follow up?

2. Follow up after radical treatment

What is the most clinically and cost-effective follow-up protocol for people with prostate cancer who have had radical treatment, with specific regard to risk stratification, duration of follow up, frequency of follow-up appointments, the type of examination or blood tests, and the roles of primary and secondary care in follow up?

3. Diagnosis of clinically significant cancer

What is the most clinically and cost-effective pathway for diagnosing clinically significant prostate cancer?

4. Progression of cancer

What is the most clinically and cost-effective pathway for excluding the clinically significant progression of cancer in people with CPG 1, 2 and 3 prostate cancer?

5. Natural history of prostate cancer

What is the natural history of people with a Likert score on MRI of less than 3 without biopsy at long-term follow up?

Staging investigations for CPG 3 prostate cancer

What is the diagnostic accuracy of staging investigations for CPG 3 prostate cancer?

Diagnosing prostate cancer

In patients with negative MRI (Likert score 1 or 2), what is the next best diagnostic investigation to rule out clinically significant prostate cancer?

What is the diagnostic accuracy of transperineal mapping biopsy compared with transperineal non-mapping biopsy in the diagnosis of clinically significant prostate cancer?

Zoledronic acid

What is the effectiveness and cost effectiveness of different scheduling of zoledronic acid in the prevention and reduction of skeletal events in people with hormone-refractory prostate cancer?

Why the committee made the recommendations

The committee saw no new evidence to suggest that any changes were needed to the recommendations on imaging in people who are not going to have radical treatment.

There was good evidence that showed that multiparametric MRI is useful in identifying lesions before biopsy, and the combination of MRI with prostate biopsy leads to better identification of clinically significant prostate cancer than systematic prostate biopsy alone. The committee recommended using a 5-point Likert scale because this scale takes into account clinical factors and not just the lesion size, improving the diagnostic ability of multiparametric MRI.

The committee made a recommendation to consider omitting prostate biopsy for people whose multiparametric MRI Likert score is 1 or 2 because there was some evidence that this is safe to do. However, there is a small risk that in some cases significant cancers may be missed, so the committee recommended clinicians discuss the risk and benefits with the person.

Based on their expertise and economic evidence, the committee recommended not offering mapping transperineal template biopsy as an initial biopsy, because the technique is currently too resource intensive to be used as an initial assessment – it requires general anaesthetic and extensive histological analysis. The committee recognised that this technique could be allowed as part of a clinical trial because it is often used as the benchmark or gold standard test in those trials. The committee did not see any evidence that allowed them to clearly differentiate between transperineal (non-mapping) and transrectal biopsy, so it agreed to refer to ‘prostate biopsy’ throughout the recommendations.

As there was limited evidence on the most effective pathway for excluding clinically significant progression of prostate cancer in people with low to intermediate risk, the committee made a recommendation for research on this topic. They also identified that there was a gap in the evidence on the most suitable surveillance protocol in this population group.

How the recommendations might affect practice

The recommendations should not have a significant resource impact as many centres already perform MRI-influenced biopsy. Since all people who have a biopsy will previously have had an MRI, using the MRI to target the biopsy will be more efficient and need fewer biopsy cores to be taken. Health economic evidence shows that MRI-influenced prostate biopsy may be more cost effective than systematic prostate biopsy as it takes less time and is more efficient in identifying clinically significant cancer.

Return to recommendations

Why the committee made the recommendations

There was no clinical evidence in this area, therefore the committee used evidence from economic modelling that showed people with a negative diagnosis of prostate cancer can still be at substantial risk of having prostate cancer, so follow up is important. The evidence showed that the prevalence of initially undetected, but clinically significant, prostate cancer varies based on a person’s diagnostic history, so their diagnostic history should influence the frequency of follow up.

The committee recommended that people with a Likert 3 score should be discussed at a multidisciplinary team (MDT) meeting. It made the recommendation because these cases can be difficult to deal with. Scoring of scans may fluctuate by 20% between raters and therefore a discussion in an MDT is warranted. The committee noted that this does not necessarily imply the full cancer MDT, but is subject to local arrangement.

The follow-up strategies recommended for primary care are based on standard prostate-specific antigen (PSA) tests, with which primary care healthcare professionals are familiar. The committee agreed it was important that specialist healthcare professionals should calculate thresholds for re-referral and provide these when discharging people, rather than expecting the calculations to be made in primary care.

The recommendations in NICE’s previous guidance on PCA3 assay and the Prostate Health Index (NICE diagnostic guidance 17) are updated by this guideline. The committee saw no evidence that either technique represents an effective use of NHS resources in the follow up of people who have had a negative transrectal ultrasound-guided (TRUS) prostate biopsy, and therefore the committee did not recommend use of these technologies.

The committee identified a gap in the evidence for the performance of transperineal route (non-mapping) biopsy, and therefore made a recommendation for research in this area.

The committee also noted that there is limited long-term follow-up evidence on the natural history of people whose multiparametric MRI Likert score is 1 or 2. In addition, there is limited evidence on the number of people whose multiparametric MRI is Likert score 1 or 2, who have normal PSA density and kinetics and who are found to have clinically significant cancer. Further recommendations for research were made in these areas to help provide evidence across the prostate cancer treatment pathway.

How the recommendations might affect practice

Currently, there is substantial variation in clinical practice in the follow up of people with a negative prostate biopsy. The committee’s recommendations should help to standardise practice.

Other recommendations made by the committee make it likely that more people will have a negative diagnosis on the basis of low-risk multiparametric MRI findings and no biopsy. This is a new population who will need effective follow-up strategies, and the recommendations give guidance on approaches that are likely to provide a good balance of benefits, harms and costs for this group.

The committee were confident that none of the recommendations would have a significant resource impact, as they are based on PSA measurements that are commonly used within primary care settings. In addition, if further multiparametric MRI is needed during follow up, the evidence showed that MRI-influenced prostate biopsy may be more cost effective than systematic prostate biopsy, as it takes less time and is more efficient in identifying clinically significant cancer.

Return to recommendations

Why the committee made the recommendation

The 2019 guideline used a 3-tier model for risk stratification. The committee agreed that newer evidence shows 5-tier risk stratification models are better at predicting prostate cancer-specific mortality than 3-tier models. More accurate prognosis will mean that more people are given the most effective treatment. The committee recommended the 5-tier Cambridge Prognostic Group (CPG) model over other 5-tier models because it has been tested in UK populations.

Impact on other recommendations

The committee considered the impact of recommending the CPG risk stratification model on other recommendations in the guideline. Recommendations were amended as necessary, taking into account the original evidence for each recommendation and the committee’s knowledge and experience.

How the recommendation might affect practice

The committee were confident that recommending the 5-tier CPG risk stratification model would not have a significant resource impact. This was because the same information is used to calculate both the CPG model and the previously recommended 3-tier model. However, MDTs will need to be aware of the new 5-tier model when assessing patient risk.

Under the 5-tier CPG risk stratification model more people would be in the lowest risk group (CPG 1) than were previously categorised as ‘low risk’. The previous ‘intermediate-risk’ group now consists of some people in CPG 1, and all people in CPG 2 and CPG 3, and recommendations that were previously for people at ‘intermediate risk’ would now apply to a smaller group. CPG 4 and CPG 5 directly align to the previous ‘high-risk’ group, so the number of people in this category would not change. These changes are not expected to affect treatment choices in a way that would have a significant resource impact.

Return to recommendation

Why the committee made the recommendation

The 2019 guideline recommended that bone scans should not be used for people with low-risk prostate cancer. This recommendation was amended to refer to the CPG 1 and 2 populations. The committee were aware that this population is broader than the original low-risk population, but agreed that it was in line with current practice not to offer bone scans to these groups because they have very low risks of bone metastases. The committee highlighted the lack of evidence on when to offer staging investigations to the CPG 3 group and the potential resource impact of the investigations, and made a recommendation for research in this area.

How the recommendation might affect practice

Recommendations where low risk was replaced with CPG 1 and 2 will apply to a broader population due to the inclusion of people with T2b prostate cancer. However, the committee agreed that the associated resource impact of this change would be minimal because it is in line with current practice.

Return to recommendation

Why the committee made the recommendations

How the recommendations might affect practice

Recommendations where low risk was replaced with CPG 1 are likely to apply to a broader population due to the inclusion of people with T2b prostate cancer. However, the committee agreed that the associated resource impact of this change would be minimal because although there is more emphasis on active surveillance, the other treatment options are still available.

Return to recommendations

Why the committee made the recommendations

The committee made recommendations based on a good body of evidence that multiparametric MRI can be used as part of an active surveillance protocol to identify clinically significant cancer, or restage prostate cancer after diagnosis. The committee took into account the benefits seen in using multiparametric MRI pre-biopsy in people who have not had a biopsy and who have suspected prostate cancer. The committee concluded that this benefit can be extended to people having active surveillance without having had an MRI to allow for confirmation or reclassification of the prostate cancer.

The committee amended the protocol for active surveillance based on their expertise and good evidence on PSA-derived measures to monitor, and the use of multiparametric MRI to identify, clinically significant prostate cancer. The committee kept the use of digital rectal examination (DRE) in this population because they did not see any new evidence to not recommend it for this group. In addition, DRE was part of the protocol in 1 of the studies included in the evidence review.

Because of the limited evidence on the most effective pathway for excluding clinically significant progression of prostate cancer in people with low to intermediate risk, the committee made recommendations for research in this area. They also identified that there was a gap in the evidence on the most suitable surveillance protocol for this population group, including the use of DRE.

How the recommendations might affect practice

The use of multiparametric MRI in people who are enrolled on active surveillance will influence active surveillance protocols across the country. Multiparametric MRI is clinically and cost effective, because clinically significant cancers are more likely to be identified, therefore decisions on treatment can be made earlier in the diagnosis pathway saving on future treatment costs.

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Why the committee made the recommendations

The 2014 and 2019 recommendations on hormone treatment and brachytherapy for intermediate and high-risk prostate cancer were amended to cover the CPG 2 to 5 groups. The committee agreed these groups are broadly equivalent to the groups in the 2019 guideline and reflect the populations that will have radical radiotherapy. The recommendations for high-risk prostate cancer were amended to CPG 4 and 5 as these are the equivalent groups.

In 2019, the committee considered a large body of evidence showing that hypofractionated radiotherapy and conventional radiotherapy were equally effective. The committee noted that hypofractionated radiotherapy is associated with higher rates of acute gastrointestinal toxicity, but overall it could enable people to have a better quality of life because they would need to make fewer clinic visits. Fewer clinic visits for hypofractionated radiotherapy would also mean fewer resources were needed compared with conventional radiotherapy treatment. Therefore, hypofractionated radiotherapy was recommended as the first option.

The committee agreed that 60 Gy in 20 fractions was the optimal dose for people having hypofractionated radiotherapy. This was the dosage used in the large UK CHHiP trial that was associated with greater efficacy compared with a 57 Gy schedule, although the 60 Gy schedule did also show slightly greater toxicity.

The 2019 committee considered evidence from a large trial that showed a reduction in biochemical failure (for example, local recurrence or distant metastases) associated with the use of low dose-rate brachytherapy plus external beam radiotherapy for people with high-risk localised prostate cancer (now updated to the equivalent CPG 4 and 5 groups in the recommendation). As a result, the committee amended the 2014 recommendation so it was not limited to high dose-rate brachytherapy. The committee also agreed that as most centres do not offer both types of brachytherapy, the advice gives clinicians a choice of either high dose-rate or low dose-rate brachytherapy.

How the recommendations might affect practice

As hypofractionated radiotherapy is already routinely used in practice (alongside other non-radiotherapy treatment options) for people with localised prostate cancer, these recommendations are unlikely to have an impact on resources.

For brachytherapy (high dose-rate or low dose-rate), the committee agreed that only a small number of people (typically those with CPG 4 and 5 prostate cancer) would currently have brachytherapy, so the changes to the recommendations are unlikely to have a significant impact on current practice.

Recommendations where intermediate risk was replaced with CPG 2 and 3 are likely to apply to a smaller group of people. Therefore, the committee agreed that the changes were unlikely to result in an increased use of resources.

Recommendations for high-risk prostate cancer were changed to be for CPG 4 and 5, but because these groups are equivalent there would be no resource impact.

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Why the committee made the recommendations

There was good evidence that showed docetaxel improves overall survival, prostate cancer-specific survival and clinical progression-free survival in people with newly diagnosed metastatic prostate cancer who are starting long-term hormone therapy. The committee agreed these benefits outweighed the potential harms of the treatment.

The evidence also showed docetaxel slows clinical progression in people with newly diagnosed high-risk, non-metastatic cancer starting long-term hormone therapy. However, the evidence did not show any extension of overall survival. Because of the known toxicities associated with docetaxel treatment, the benefits and harms are more finely balanced in this population. As a result, the committee identified this decision as being preference sensitive, and the person’s values and preferences are likely to be particularly important in their decision about the best course of action for them.

The committee also made a recommendation for research as it identified a gap in the evidence related to there being no universal definition of locally advanced prostate cancer. A risk stratification study will help identify patients at various levels of risks, and help tailor treatment according to need.

How the recommendations might affect practice

Off-label use of docetaxel in people diagnosed with hormone-sensitive metastatic prostate cancer is current practice, therefore the recommendation for the metastatic prostate cancer population is likely to have no impact. However, this does not include high-risk, non-metastatic prostate cancer. Therefore, the recommendation for this population could result in an increase in the number of people with high-risk, non-metastatic prostate cancer receiving docetaxel chemotherapy. Although this could result in an increase in some shorter-term costs to the NHS, the economic evidence showed a reduction in longer-term management costs, with the net effect that docetaxel is likely to be cost-saving in the long term in this population and, once its benefits are also taken into account, almost certain to represent a good use of NHS resources.

Return to recommendations 1.3.26 and 1.3.27

Return to recommendation 1.5.6

Why the committee made the recommendations

The committee saw no new evidence to suggest any changes were needed to the recommendations on follow-up strategies after radical treatment. The committee did not change the existing recommendations that DRE should not be offered, as there was no new evidence to suggest it was beneficial for people who were not on active surveillance.

Based on their expertise, the committee amended the recommendations on the location of the follow up. The committee discussed different strategies already in use across the country such as shared care, supported self-management and telephone-based follow up. Because it had not looked at the specific evidence for these, it was unable to recommend a specific programme. The committee agreed that the 2-year follow up recommended in the previous guideline was conservative, and based on their expertise, people with no complications and with a stable PSA could be cared for outside of the hospital environment. Complex cases might need longer contact with hospital-based services.

Given the lack of evidence, the committee also made a recommendation for research in this area.

How the recommendations might affect practice

The committee noted that follow-up strategies are variable across the country and the recommendations will therefore have a varied resource impact across the country depending on the level of follow up that is currently in place locally. Depending on the changes implemented, there may be a large resource impact.

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Why the committee made the recommendations

There was some evidence that showed zoledronic acid prolonged the time without skeletal-related events in people with hormone-refractory metastatic prostate cancer. However, the committee could not make a stronger recommendation because the evidence did not show whether zoledronic acid affects mortality in this population.

There was no new evidence that could affect the existing recommendation on the administration of bisphosphonates for pain relief for people with hormone-refractory metastatic prostate cancer.

How the recommendations might affect practice

There may be a small increase in the cost of hormone-refractory metastatic prostate cancer treatment, but as zoledronic acid is now out of patent, this should limit the cost impact.

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