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Implementing NICE guidance

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1 Implementing NICE guidance
Prostate cancer Implementing NICE guidance ABOUT THIS PRESENTATION: This presentation has been written to raise awareness of the NICE clinical guideline on Prostate cancer: diagnosis and treatment. This guideline has been written for healthcare professionals and other staff who care for men with prostate cancer. The guideline is available in a number of formats. You can download these from the NICE website or order printed copies of the quick reference guide by calling NICE publications on or sending an to Quote reference number N1457.You should hand out copies of the quick reference guide at your presentation so that your audience can refer to it. You may also find it helpful to refer to the prostate cancer pathway algorithms provided in appendix C of the NICE guideline which can also be downloaded from You can add your own organisation’s logo alongside the NICE logo. We have included notes for presenters broken down into ‘key points to raise’ for you to highlight these in your presentation and ‘additional information’ that you may want to draw on . Where necessary the recommendations will be given in full. DISCLAIMER This slide set is an implementation tool and should be used alongside the published guidance. This information does not supersede or replace the guidance itself. 2008 NICE clinical guideline 58

2 What this presentation covers
Background Key priorities for implementation Costs and savings Discussion Find out more NOTES FOR PRESENTERS: The NICE guideline contains lots of recommendations about how care can be improved, but the experts who wrote the guideline have chosen 11 key recommendations that they think will have the greatest impact on care and are the most important priorities for implementation. You can find these in your quick reference guide. The key priorities for implementation cover the following areas. Communication and support Diagnosing prostate cancer - biopsy Determining the prostate cancer stage Localised prostate cancer - treatment options Active surveillance Radical treatment Managing the side effects of treatment Managing relapse after radical treatment Metastatic prostate cancer - hormone-refractory prostate cancer Metastatic prostate cancer - palliative care. Costs and savings that are likely to be incurred in implementing the guideline are summarised, followed by a suggested list of questions to help prompt discussion. Information on how to find out more about the support provided by NICE is given at the end of this presentation.

3 Background Prostate cancer is the most common cancer in men, it accounts for 24% of all new male cancer diagnoses The annual incidence in England is about 29,000 cases Evidence shows practice variation and patchy availability of treatments and procedures around the country Treatment and care should take into account the man’s needs and preferences NOTES FOR PRESENTERS: Key points to raise: Information from Cancer Research UK: Prostate cancer is perhaps the most enigmatic malignancy in men. If men lived long enough, they would almost all die with histological evidence of the disease (Selly et al, 1997). However, only 3% of men would die as a consequence of prostate cancer. This clinical guideline will help to address these issues and offer guidance on best practice. Men with prostate cancer should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. Information and support should be available at all stages of treatment and decision making. A holistic approach should be taken when caring for men with prostate cancer. Additional information: This guideline will support current national initiatives outlined in, for example, the ‘NHS Cancer Plan’, the ‘Manual for Cancer Services for England’ and the ‘Wales Cancer Standards’. The guideline also refers to the NICE cancer service guidance documents ‘Improving outcomes in urological cancers’ and ‘Improving supportive and palliative care for adults with cancer’ and the clinical guideline documents ‘Referral guidelines for suspected cancer’.

4 Communication and support
Healthcare professionals should: inform men and their partners or carers about the effects of prostate cancer and the treatment options on their sexual function, physical appearance, continence and other aspects of masculinity support men and their partners or carers in making treatment decisions, taking into account the effects on quality of life as well as survival. NOTES FOR PRESENTERS: General points to raise: More information on communication and support is given in the NICE guideline, section 1.1. Follow the communication recommendations given in ‘Improving outcomes in urological cancers’ and ‘Improving supportive and palliative care for adults with cancer’ (NICE cancer service guidance). Advise on sources of information and support, including cancer information services, support groups and websites (for example, UK Prostate Link – Check their content is clear, reliable and up-to-date and seek feedback on their quality. Key recommendation in full: Healthcare professionals should adequately inform men 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 and other aspects of masculinity. Healthcare professionals should support men and their partners or carers in making treatment decisions, taking into account the effects on quality of life as well as survival. [1.1.10, NICE guideline]

5 Diagnosing prostate cancer: definitions
Prostate specific antigen A protein produced by the prostate gland which tends to be higher in men with prostate cancer Gleason score An internationally agreed grading system which gives an overall cell abnormality score to help predict prostate tumour progression Clinical stage A classification system (TNM) is used in prostate cancer to describe: the extent of the primary tumour (T) - the absence or presence of spread to nearby lymph nodes (N) - the absence or presence of distant spread, or metastasis (M) NOTES FOR PRESENTERS: Key points to raise: Prostate specific antigen (PSA): a protein produced by the prostate gland and identified in the blood. Men with prostate cancer tend to have higher levels of PSA in their blood (although most men with prostate cancer have normal PSA levels). PSA levels may also be increased by conditions other than cancer and levels tend to increase naturally with age. Gleason score: an internationally recognised grading system, based on examination of tissue obtained by prostate biopsy, where a pathologist allocates an overall cell abnormality score that can help predict prostate tumour progression. The scale runs from 2 to 10, with 2− 6 often described as 'non aggressive', 7 as 'moderately aggressive' and 8−10 as 'aggressive'. Clinical stage - The TNM classification (see appendix 2, full guideline) is used to stage prostate cancer. It describes the extent of the primary tumour (T stage), the absence or presence of spread to nearby lymph nodes (N stage) and the absence or presence of distant spread, or metastasis (M stage). T1 - Clinically unapparent tumour, not detected by digital rectal examination, or visible by imaging T2 - Confined within the prostate T3 - Tumour extends through the prostate capsule but has not spread to other organs T4 - Tumour is fixed or invades adjacent structures other than seminal vesicles

6 Diagnosing prostate cancer: biopsy
To help men decide, healthcare professionals should discuss with them their: prostate specific antigen (PSA) level digital rectal examination (DRE) findings comorbidities risk factors (age/ethnicity/family history) history of a previous negative biopsy Serum PSA alone should not automatically lead to biopsy, as it is a poor discriminator of the presence of cancer NOTES FOR PRESENTERS: General points to raise: The aim of prostate biopsy is to detect prostate cancers with the potential for causing harm rather than detecting each and every cancer. Men with clinically insignificant prostate cancers that are unlikely to cause symptoms or affect life expectancy may not benefit from knowing that they have the disease. Indeed, the detection of clinically insignificant prostate cancer should be regarded as an under-recognised adverse effect of biopsy. Risk factors include increasing age and black African or black Caribbean ethnicity. Key recommendation in full: To help men decide whether to have a prostate biopsy, healthcare professionals should discuss with them their PSA level, DRE findings (including an estimate of prostate size) and comorbidities, together with their risk factors (including increasing age and black African or black Caribbean ethnicity) and any history of a previous negative prostate biopsy. The serum PSA level alone should not automatically lead to a prostate biopsy. [1.2.1, NICE guideline] Additional information: PSA alone is a poor discriminator of the presence of cancer. Rationale – Traditionally anything up to 4 ng/ml for total PSA level (tPSA) was considered satisfactory. Above this value a biopsy would be considered. However, only around 30% of men with levels between 4−10 ng/ml will have prostate cancer on biopsy (Raaijmakers et al, 2004). Conversely as many as 15% of men with PSA values below 4 ng/ml will have cancer, and some of these will be clinically significant. A cut-off of 4 ng/ml is therefore not ideal and in clinical practice there is no precise PSA value at which to recommend a biopsy. For more information on the evidence please refer to the full guideline.

7 Localised prostate cancer: treatment options
NOTES FOR PRESENTERS: Key points to raise: This slide summarises the treatment options for men with low, intermediate or high risk localised prostate cancer: watchful waiting, active surveillance and radical treatments. The next slide (8) shows the risk stratification for localised prostate cancer and slide 9 gives more information on radical treatments. Definitions of terms used: Watchful waiting: this is a method of managing men with prostate cancer who are not suitable for radical treatment, involving treatment only if and when they develop symptoms. If men choose watchful waiting and show evidence of disease progression, they should be reviewed by a member of the urological cancer MDT. Active surveillance: this is a method of managing men with low or intermediate-risk localised prostate cancer that aims to target radical treatment only to those who would benefit most. Radical treatment: treatment given with the aim of cure, rather than just improving symptoms. Prostatectomy - surgery to remove part, or all of the prostate gland. Radical prostatectomy aims at the removal of the entire prostate gland and lymph nodes. This can be performed by an open approach or by keyhole technique. Brachytherapy - a form of radiotherapy given by inserting radioactive seeds directly into the prostate. Conformal radiotherapy - radiotherapy that uses a number of different techniques to shape the beam and miss normal tissues. Cryotherapy - treatment which aims to eradicate prostate cancer by freezing the prostate gland. High-intensity focused ultrasound (HIFU) - a technique where high-frequency ultrasound waves are aimed at the cancer, heating up the cells with the aim of causing cell death and eradicating the cancer. Additional information: Gy is an abbreviation for Gray, a unit of measurement of radiation exposure in radiotherapy.

8 Active surveillance Men with low-risk localised prostate cancer who are considered suitable for radical treatment should first be offered active surveillance Risk stratification criteria for men with localised prostate cancer PSA (ng/ml) Gleason score Clinical stage Low risk < 10 and ≤ 6 T1−T2a Intermediate risk 10−20 or 7 T2b−T2c High risk > 20 8−10 T3−T4 NOTES FOR PRESENTERS: Key points to raise: Active surveillance is the preferred option for low-risk men who are candidates for radical treatment. It is particularly suitable for men with clinical stage T1c, Gleason score 3+3 and PSA density < 0.15 ng/ml/ml who have cancer in less than 50% of their biopsy cores, with < 10 mm of any core involved. Candidates for active surveillance should: - have had at least 10 biopsy cores taken - have at least one re-biopsy which may be performed according to the ProSTART protocol (A phase III randomized study of active surveillance versus radical treatment in patients with favorable-risk prostate cancer. Available from If men on active surveillance show evidence of disease progression, offer radical treatment. Treatment decisions should be made with the man, taking into account comorbidities and life expectancy. Key recommendation in full: as shown on slide [1.3.3, NICE guideline] Additional information: Men with clinical stage T3−T4 cancers have locally advanced disease. There is no universally accepted definition of locally advanced prostate cancer. It covers a spectrum of disease from a tumour that has spread through the capsule of the prostate (T3a) to large T4 cancers that may be invading the bladder or rectum or have spread to pelvic lymph nodes (more information, including treatment options, is given in the NICE guideline, section 1.6).

9 Radical treatment (1) Men undergoing radical external beam radiotherapy for localised prostate cancer should receive a minimum dose of 74 Gy to the prostate at no more than 2 Gy per fraction This may also apply to some men with locally advanced prostate cancer NOTES FOR PRESENTERS: Key points to raise: All candidates for radical treatment should have the opportunity to discuss their treatment options with a surgical oncologist and a clinical oncologist. Key recommendation in full: as shown on slide [1.3.15, NICE guideline] Additional information: The radical treatment recommendations are given in −1.3.17, NICE guideline (refer back to ‘Treatment options’ slide here for the full range of radical treatment options). Offer radical radiotherapy (conformal) or radical prostatectomy to men with intermediate-risk localised prostate cancer and to men with high-risk localised disease if there is a realistic prospect of long-term disease control. [ and , NICE guideline] Brachytherapy is not recommended for men with high-risk localised disease.[ , NICE guideline] Clinical oncologists should use conformal radiotherapy for men with localised prostate cancer receiving radical external beam radiotherapy. (This may also apply to some men with locally advanced prostate cancer). [ , NICE guideline] Offer adjuvant hormonal therapy for a minimum of 2 years to men receiving radiotherapy who have a Gleason score of ≥ 8. [ , NICE guideline] External beam radiotherapy: radiotherapy given by using ionising radiation (high energy X-rays) produced in a machine and directed at the tumour from outside the patient. Radiotherapy is usually given over an extended period of time. The dose delivered at each treatment is known as a fraction; therefore 74 Gy at no more than 2 Gy per fraction is equal to 37 outpatient attendances.

10 Radical treatment (2) High-intensity focused ultrasound (HIFU) and cryotherapy Not recommended other than in controlled clinical trials NICE has had discussions with the British Association of Urological Surgeons (BAUS) and relevant research bodies HIFU trial recruiting (June 2008) Cryotherapy trial currently in design (June 2008) NOTES FOR PRESENTERS: Key points to raise: High-intensity focused ultrasound (HIFU) and cryotherapy are not recommended for men with localised prostate cancer other than in the context of controlled clinical trials comparing their use with established interventions. [ , NICE guideline] [1] The GDG considered that the evidence base was insufficient to place High Intensity Focused Ultrasound (HIFU) or cryotherapy in the pathway of care for men with prostate cancer. They recommended that further research is required: Cryotherapy: NICE has been in discussion with Industry, the British Association of Urological Surgeons (BAUS) and the Health Technology Assessment programme of the National Institute for Health Research to identify a way forward. It is anticipated that a national data collection will be established and surgeons wishing to undertake this procedure will be expected to contribute to the evidence base. The design and nature of this national study will be discussed with the BAUS. At the present time if surgeons are collecting local data that will be available for national analysis then this should be considered in accordance with the NICE guideline. HIFU: There is a current trial assessing the treatment of areas of prostate cancer within the prostrate gland (focal ablation) funded by Cancer Research UK.http://www.cancerhelp.org.uk/default.asp NICE has been in discussion with Industry and has been informed that Disease Registries are being established in the UK. If surgeons are recruiting patients into a trial or collecting registry data that will be available for comparative assessment then this should be considered in accordance with the NICE guidance.

11 Managing the side effects of treatment
Healthcare professionals should: ensure that men and their partners have early and ongoing access to specialist erectile dysfunction services ensure that men with troublesome urinary symptoms after treatment have access to specialist continence services refer men with intractable stress incontinence to a specialist surgeon for consideration of an artificial urinary sphincter. NOTES FOR PRESENTERS: Key points to raise: Erectile dysfunction: Before treatment, men and their partners should be warned that treatment for prostate cancer will result in alteration of sexual experience, and may result in loss of sexual function. Men and their partners should be warned about the potential loss of ejaculation and fertility, sperm storage should be offered. Men with prostate cancer who experience loss of erectile function should be offered phosphodiesterase (PDE5) inhibitors to improve their chances of spontaneous erections. If PDE5 inhibitors fail to work or are contraindicated, vacuum devices, intraurethral inserts, penile injections or penile prostheses should be offered as an alternative. Troublesome urinary symptoms/stress incontinence: Conservative treatment of troublesome urinary symptoms may include coping strategies, along with pelvic floor muscle re-education, bladder retraining and pharmacotherapy. Injection of bulking agents into the distal urinary sphincter is not recommended to treat stress incontinence. Key recommendations in full: Erectile dysfunction: as shown on slide [1.4.8, NICE guideline]. Related recommendations - loss of sexual function and fertility [ , NICE guideline], access to psychosexual specialists [1.1.11, NICE guideline]. Healthcare professionals should ensure that men with troublesome urinary symptoms after treatment have access to specialist continence services for assessment, diagnosis and conservative treatment. This may include coping strategies, along with pelvic floor muscle re-education, bladder retraining and pharmacotherapy [1.4.13, NICE guideline]. Related recommendations - loss of urinary function, stress incontinence [ , NICE guideline]. Additional information: Further information on managing the adverse effects of treatment is given in section 1.4, NICE guideline. Side effects may also include radiation-induced damage, side effects of hormonal treatments and pain. For more information on follow-up, see recommendations , NICE guideline.

12 Managing relapse after radical treatment
Biochemical relapse (rising prostate specific antigen) alone should not necessarily prompt an immediate change in treatment Hormonal therapy is not routinely recommended for men with prostate cancer who have a biochemical relapse unless they have: symptomatic local disease progression, or any proven metastases, or a PSA doubling time < 3 months. NOTES FOR PRESENTERS: Key points to raise: More information on managing relapse after radical treatment is given in the NICE guideline, section 1.5. Key recommendations in full: as shown on slide [1.5.5 and 1.5.9, NICE guideline] Additional information: Biochemical relapse should trigger an estimate of PSA doubling time, based on a minimum of 3 measurements over at least a 6 month period [1.5.6, NICE guideline]. Men with biochemical relapse after radical prostatectomy, with no known metastases, should be offered radical radiotherapy to the prostatic bed [1.5.7, NICE guideline]. Men with biochemical relapse should be considered for entry to appropriate clinical trials [1.5.8, NICE guideline].

13 Metastatic prostate cancer: hormone-refractory disease
When men with prostate cancer develop biochemical evidence of hormone-refractory disease, their treatment options should be discussed by the urological cancer multidisciplinary team with a view to seeking an oncologist and/or specialist palliative care opinion, as appropriate NOTES FOR PRESENTERS: Key points to raise: The NICE guideline includes recommendations on hormonal therapy, managing the complications of hormonal therapy, hormone-refractory prostate cancer and palliative care. More information on the pharmacological treatment of hormone-refractory prostate cancer (for example the use of docetaxel and corticosteroids) and recommendations on imaging are given in sections − of the NICE guideline. Recommendations , and identify treatments which are NOT recommended. Key recommendation in full: as shown on this slide [1.7.10, NICE guideline] Additional information: Docetaxel is recommended, within its licensed indications, as a treatment option for men with hormone-refractory prostate cancer only if their Karnofsky performance-status score is 60% or more [1.7.11, NICE guideline]. 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 [1.7.12, NICE guideline]. Repeat cycles of treatment with docetaxel are not recommended if the disease recurs after completion of the planned course of chemotherapy [1.7.13, NICE guideline]. NOTE: These recommendations are from ‘Docetaxel for the treatment of hormone-refractory metastatic prostate cancer’ (NICE technology appraisal guidance 101).

14 Metastatic prostate cancer: palliative care
Healthcare professionals should ensure that palliative care is available when needed and is not limited to the end of life It should not be restricted to being associated with hospice care NOTES FOR PRESENTERS General points to raise: The following related recommendations offer further guidance on this issue [ −1.7.26, NICE guideline]. Discuss the man’s preferences for palliative care (and those of his partner and carers) as soon as possible. Identify the preferred place of care. Do not limit palliative care to hospice care; integrate into coordinated care and ensure it is available when needed. Offer: - tailored information and treatment and care plan - access to specialist urology and palliative care teams to discuss changes in disease status or symptoms - a regular assessment of the man’s needs. Key recommendation in full: as shown on slide [1.7.27, NICE guideline]

15 Costs and savings per 100,000 male population
Recommendations with significant resource impact Annual cost (saving) £000 Decision whether or not to biopsy (9.0) Offering active surveillance (4.1) Course of radical external beam radiotherapy 23.8 Hormonal therapy (20.7) Total saving (10.1) NOTES FOR PRESENTERS: The information on this slide has been extracted from the NICE costing report which has been provided by NICE to support implementation of this guidance. It was developed after careful consideration of the available data and by working closely with the guideline developers and other people in the NHS. It is not NICE guidance. Assumptions used in this report are based on assessment of the national average and it is recognised that local practice or circumstances may differ from this. The costs published in this report are estimates only and are not to be taken as the Institute's view of desirable, or maximum or minimum figures. NICE has also provided a costing template to help calculate the local costs associated with implementing this guideline. The costs per 100,000 male population are summarised in the table. It is recognised that implementation of the recommendations may take place over a number of years. In addition, compliance with NICE guidance is one of the criteria indicating good risk reduction strategies, and in combination with meeting other criteria could lead to a discount on contributions to the NHS Litigation Authority schemes, including the clinical negligence scheme for trusts (CNST).

16 Discussion Which recommendations will require a change in practice for you? Which existing practices that are no longer recommended allow the transfer of resources? What is the current service provision for erectile dysfunction, specialist continence radiology and palliative care services? How do we ensure that patients and staff understand the difference between watchful waiting, active surveillance and the choices of treatment? How do we do effectively support patients in deciding whether to have a prostate biopsy? NOTES FOR PRESENTERS: These questions are suggestions that we have developed to help provide a prompt for a discussion at the end of your presentation - please edit and adapt these to suit your local situation. As part of the discussion consider what you would need to implement this guideline.

17 Find out more Visit www.nice.org.uk/cg058 for: Other guideline formats
Costing report and template Audit support Implementation advice NOTES FOR PRESENTERS: The guideline is available in a number of formats: The quick reference guide – which summarises the guidance The NICE guideline – which includes all of the recommendations in full. Appendix C of the NICE version contains the following algorithms: prostate cancer pathway, diagnosis and staging, localised disease, locally advanced disease, follow-up and relapse after radical treatment, metastatic disease, management of complications and side effects of treatment. The full guideline – which includes all of the evidence and rationale ‘Understanding NICE guidance’ – a version for patients and carers You can download these from the NICE website or order printed copies of the quick reference guide and ‘Understanding NICE guidance’ by calling NICE publications on or ing Quote reference number N1457 (quick reference guide) and N1458 (‘Understanding NICE guidance’). You may want to hand out copies of the quick reference guide at your presentation so that your audience can refer to it. NICE has developed tools to help organisations implement this guideline, which can be found on the NICE website. Costing tools – a costing report gives the background to the national savings and costs associated with implementation, and a costing template allows you to estimate the local costs and savings involved. These were published at the same time as the guideline. The following tools will published approximately 10 weeks after publication of the guideline, in May 2008. Audit support assists NHS trusts to determine how well they meet NICE recommendations. Implementation advice gives details of how to put the guidance into practice and national initiatives that support this locally.


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