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National Collaborating Centre for Cancer (UK). Prostate Cancer: Diagnosis and Treatment. Cardiff (UK): National Collaborating Centre for Cancer (UK); 2008 Feb. (NICE Clinical Guidelines, No. 58.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Prostate Cancer: Diagnosis and Treatment.

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Recommendations

Chapter 2: Communication and Support

The recommendations on communication and patient-centred care made in the two NICE cancer service guidance documents ‘Improving outcomes in urological cancers’ (2002) and ‘Improving supportive and palliative care for adults with cancer’ (2004) should be followed throughout the patient journey.

Men with prostate cancer should be offered individualised 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 (for example, slide sets or DVDs).

Men with prostate cancer should be offered advice on how to access information and support from websites (for example, UK Prostate Link - www.prostate-link.org.uk), local and national cancer information services, and from cancer support groups.

Before choosing or recommending information resources for men with prostate cancer, health-care professionals should check that their content is clear, reliable and up to date.

Healthcare professionals should seek feedback from men with prostate cancer and their carers to identify the highest quality information resources.

Healthcare professionals caring for men with prostate cancer should ascertain the extent to which the man wishes to be involved in decision making and ensure that he has sufficient information to do so.

A validated, up-to-date decision aid is recommended for use in all urological cancer multidisciplinary teams (MDTs). It should be offered to men with localised prostate cancer when making treatment decisions, by healthcare professionals trained in its use1.

Healthcare professionals should discuss all relevant management options recommended in this guideline with men with prostate cancer and their partners or carers, irrespective of whether they are available through local services.

Healthcare professionals should ensure that mechanisms are in place to allow men with prostate cancer and their primary care providers to gain access to specialist services throughout the course of their disease.

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.

Healthcare professionals should offer men 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 illness and its treatment.

Chapter 3: Diagnosis and Staging of Prostate Cancer

Biopsy

To help men decide whether to have a prostate biopsy, healthcare professionals should discuss with them their prostate specific antigen (PSA) level, digital rectal examination (DRE) findings (including an estimate of prostate size) and comorbidities, together with their risk factors (including increasing age and black African and 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.

Men and their partners or carers should be given information, support and adequate time to decide whether or not they wish to undergo prostate biopsy. The information should include an explanation of the risks (including the increased chance of having to live with the diagnosis of clinically insignificant prostate cancer) and benefits of prostate biopsy.

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), prostate biopsy for histological confirmation should not be performed, unless this is required as part of a clinical trial.

Healthcare professionals should carry out prostate biopsy following the procedure recommended in ‘Undertaking a transrectal ultrasound guided biopsy of the prostate’ (PCRMP 2006)2.

The results of all prostate biopsies should be reviewed by a urological cancer MDT. Men should only be re-biopsied following a negative biopsy after an MDT review of the risk characteristics including life expectancy, PSA, DRE and prostate volume.

Men should decide whether or not to have a re-biopsy following a negative biopsy, having had the risks and benefits explained to them.

Imaging

Healthcare professionals should determine the provisional treatment intent (radical or non-radical) before decisions on imaging are made.

Imaging is not routinely recommended for men in whom no radical treatment is intended.

Computerised tomography (CT) of the pelvis is not recommended for men with low- or intermediate-risk localised prostate cancer (see table A).

Table A. Risk stratification for men with localised prostate cancer.

Table A

Risk stratification for men with localised prostate cancer.

Men with high-risk localised (see table A) and locally advanced prostate cancer who are being considered for radical treatment should have pelvic imaging with either magnetic resonance imaging (MRI), or CT if MRI is contraindicated.

Magnetic resonance spectroscopy is not recommended for men with prostate cancer except in the context of a clinical trial.

Isotope bone scans are not routinely recommended for men with low-risk localised prostate cancer.

Isotope bone scans should be performed when hormonal therapy is being deferred through watchful waiting in asymptomatic men who are at high risk of developing bone complications.

Positron emission tomography imaging for prostate cancer is not recommended in routine clinical practice.

Nomograms

Nomograms may be used by healthcare professionals in partnership with men with prostate cancer to:

  • aid decision making
  • help predict biopsy results
  • help predict pathological stage
  • help predict risk of treatment failure.

When nomograms are used, healthcare professionals should clearly explain the reliability, validity and limitations of the prediction.

Chapter 4: Localised Prostate Cancer

Watchful waiting and active surveillance

Urological cancer MDTs should assign a risk category (see table A) to all newly diagnosed men with localised prostate cancer.

Men with localised prostate cancer who have chosen a watchful waiting regimen and who have evidence of significant disease progression (that is, rapidly rising PSA level or bone pain) should be reviewed by a member of the urological cancer MDT.

Men with low-risk localised prostate cancer (see table A) who are considered suitable for radical treatment should first be offered active surveillance.

Active surveillance is particularly suitable for a subgroup of men with low-risk localised prostate cancer who have clinical stage T1c, a Gleason score 3+3, a PSA density < 0.15 ng/ml/ml and who have cancer in less than 50% of their total number of biopsy cores with < 10mm of any core involved.

Active surveillance should be discussed as an option with men who have intermediate-risk localised prostate cancer (see table A).

Active surveillance is not recommended for men with high-risk localised prostate cancer.

To reduce the sampling error associated with prostate biopsy, men who are candidates for active surveillance should have at least 10 biopsy cores taken.

Active surveillance should include at least one re-biopsy and may be performed in accordance with the ProSTART4 protocol.

Men with localised prostate cancer who have chosen an active surveillance regimen and who have evidence of disease progression (that is, a rise in PSA or adverse findings on biopsy) should be offered radical treatment.

The decision to proceed from an active surveillance regimen to radical treatment should be made in the light of the individual man’s personal preferences, comorbidities and life expectancy.

Radical treatment

Healthcare professionals should offer radical prostatectomy or radical radiotherapy (conformal) to men with intermediate-risk localised prostate cancer.

Healthcare professionals should offer radical prostatectomy or radical radiotherapy (conformal) to men with high-risk localised prostate cancer where there is a realistic prospect of long-term disease control (see recommendations in Chapter 6).

Brachytherapy is not recommended for men with high-risk localised prostate cancer.

Clinical oncologists should use conformal radiotherapy for men with localised prostate cancer5, receiving radical external beam radiotherapy.

Men undergoing radical external beam radiotherapy for localised prostate cancer6 should receive a minimum dose of 74 Gy to the prostate at no more than 2 Gy per fraction.

Adjuvant hormonal therapy is recommended for a minimum of 2 years in men receiving radical radiotherapy for localised prostate cancer who have a Gleason score of ≥ 8.

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 interventions7.

Managing adverse effects of treatment

Given the range of treatment modalities and their serious side effects, men with prostate cancer who are candidates for radical treatment should have the opportunity to discuss their treatment options with a specialist surgical oncologist and a specialist clinical oncologist.

Men presenting with symptoms consistent with radiation-induced enteropathy should be fully investigated (including using flexible sigmoidoscopy) to exclude inflammatory bowel disease or malignancy of the large bowel and to ascertain the nature of the radiation injury. Particular caution should be taken with anterior wall rectal biopsy following brachytherapy because of the risk of fistulation.

Men treated with radical radiotherapy for prostate cancer should be offered flexible sigmoidoscopy every 5 years.

Steroid enemas should not be used for treating men with radiation proctopathy.

The nature and treatment of radiation-induced injury to the gastrointestinal tract should be included in the training programmes for oncologists and gastroenterologists.

Prior to treatment, men and their partners should be warned that treatment for prostate cancer will result in an 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 associated with treatment for prostate cancer. Sperm storage should be offered.

Healthcare professionals should ensure that men and their partners have early and ongoing access to specialist erectile dysfunction services.

Men with prostate cancer who experience loss of erectile function should be offered phosphodiesterase type 5 (PDE5) inhibitors to improve their chance of spontaneous erections.

If PDE5 inhibitors fail to restore erectile function or are contraindicated, men should be offered vacuum devices, intraurethral inserts or penile injections, or penile prostheses as an alternative.

Men experiencing troublesome urinary symptoms before treatment should be offered a urological assessment.

Men undergoing treatment for prostate cancer should be warned of the likely effects of the treatment on their urinary function.

Healthcare professionals should ensure that men with troublesome urinary symptoms after treatment should 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.

Healthcare professionals should refer men with intractable stress incontinence to a specialist surgeon for consideration of an artificial urinary sphincter.

The injection of bulking agents into the distal urinary sphincter is not recommended to treat stress incontinence.

Follow-up

Healthcare professionals should discuss the purpose, duration, frequency and location of follow-up with each man with localised prostate cancer8, and if he wishes, his partner or carers.

Men with prostate cancer should be clearly advised about potential longer term adverse effects and when and how to report them.

Men with prostate cancer who have chosen a watchful waiting regimen with no curative intent should normally be followed up in primary care in accordance with protocols agreed by the local urological cancer MDT and the relevant primary care organisation(s). Their PSA should be measured at least once a year.

PSA levels for all men with prostate cancer who are having radical treatment should be checked at the earliest 6 weeks following treatment, at least every 6 months for the first 2 years and then at least once a year thereafter.

Routine DRE is not recommended in men with prostate cancer while the PSA remains at baseline levels.

After at least 2 years, men with a stable PSA and who have had no significant treatment complications, should be offered follow-up outside hospital (for example, in primary care) by telephone or secure electronic communications, unless they are taking part in a clinical trial that requires more formal clinic-based follow-up. Direct access to the urological cancer MDT should be offered and explained.

Chapter 5: Managing Relapse After Radical Treatment

Analyse serial PSA levels after radical treatment using the same assay technique.

Biopsy of the prostatic bed should not be performed in men with prostate cancer who have had a radical prostatectomy.

Biopsy of the prostate after radiotherapy should only be performed in men with prostate cancer who are being considered for local salvage therapy in the context of a clinical trial.

For men with evidence of biochemical relapse following radical treatment and who are considering radical salvage therapy:

Biochemical relapse (a rising PSA) alone should not necessarily prompt an immediate change in treatment.

Biochemical relapse should trigger an estimate of PSA doubling time, based on a minimum of 3 measurements over at least a 6 month period.

Men with biochemical relapse after radical prostatectomy, with no known metastases, should be offered early radical radiotherapy to the prostatic bed.

Men with biochemical relapse should be considered for entry to appropriate clinical trials9.

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 of < 3months.

Chapter 6: Locally Advanced Prostate Cancer

Systemic treatment

Neoadjuvant and concurrent luteinising hormone-releasing hormone agonist (LHRHa) therapy is recommended for 3 to 6 months in men receiving radical radiotherapy for locally advanced prostate cancer.

Adjuvant hormonal therapy in addition to radical prostatectomy is not recommended, even in men with margin-positive disease, other than in the context of a clinical trial10.

Adjuvant hormonal therapy is recommended for a minimum of 2 years in men receiving radical radiotherapy for locally advanced prostate cancer who have a Gleason score of ≥ 8.

Bisphosphonates should not be used for the prevention of bone metastases in men with prostate cancer.

Radiotherapy

Clinical oncologists should consider pelvic radiotherapy in men with locally advanced prostate cancer who have a > 15% risk of pelvic lymph node involvement11 who are to receive neoadjuvant hormonal therapy and radical radiotherapy.

Immediate post-operative radiotherapy after radical prostatectomy is not routinely recommended, even in men with margin-positive disease, other than in the context of a clinical trial12.

HIFU and cryotherapy are not recommended for men with locally advanced prostate cancer other than in the context of controlled clinical trials comparing their use with established interventions13.

Chapter 7: Metastatic Prostate Cancer

Hormonal therapy

Healthcare professionals should offer bilateral orchidectomy to all men with metastatic prostate cancer as an alternative to continuous LHRHa therapy.

Combined androgen blockade is not recommended as a first-line treatment for men with metastatic prostate cancer.

For men with metastatic prostate cancer who are willing to accept the adverse impact on overall survival and gynaecomastia in the hope of retaining sexual function, anti-androgen mono-therapy with bicalutamide (150 mg)14 is appropriate.

Healthcare professionals should begin androgen withdrawal and stop bicalutamide treatment in men with metastatic prostate cancer who are taking bicalutamide monotherapy and who do not maintain satisfactory sexual function.

Intermittent androgen withdrawal may be offered to men with metastatic prostate cancer providing they are informed that there is no long-term evidence of its effectiveness.

Managing the complications of hormonal therapy

Synthetic progestogens (administered orally or parenterally) are recommended as first-line therapy for the management of troublesome hot flushes. If oral therapy is used, it should be given for 2 weeks, and re-started, if effective, on recurrence of symptoms.

Men starting long-term bicalutamide monotherapy (> 6 months) should receive prophylactic radiotherapy to both breast buds within the first month of treatment. A single fraction of 8 Gy using orthovoltage or electron beam radiotherapy is recommended.

If radiotherapy is unsuccessful in preventing gynaecomastia, weekly tamoxifen should be considered.

Inform men starting androgen withdrawal therapy that regular resistance exercise reduces fatigue and improves quality of life.

Hormone-refractory prostate cancer

When men with prostate cancer develop biochemical evidence of hormone-refractory disease, their treatment options should be discussed by the urological cancer MDT with a view to seeking an oncological and/or specialist palliative care opinion as appropriate.

Docetaxel is recommended, within its licensed indications, as a treatment option for men with hormone-refractory metastatic prostate cancer only if their Karnofsky performance-status score is 60% or more15.

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 studies15.

Repeat cycles of treatment with docetaxel are not recommended if the disease recurs after completion of the planned course of chemotherapy15.

A corticosteroid such as dexamethasone (0.5 mg daily) daily is recommended as third-line hormonal therapy after androgen withdrawal and anti-androgen therapy for men with hormone-refractory prostate cancer.

Men with hormone-refractory prostate cancer shown to have extensive metastases in the spine (for example, on a bone scan) should have spinal MRI if they develop any spinal related symptoms.

The routine use of spinal MRI for all men with hormone-refractory prostate cancer and known bone metastases is not recommended.

The use of bisphosphonates to prevent or reduce the complications of bone metastases in men with hormone-refractory prostate cancer is not recommended.

Bisphosphonates for pain relief may be considered for men with hormone-refractory prostate cancer when other treatments (including analgesics and palliative radiotherapy) have failed. The oral or intravenous route of administration should be chosen according to convenience, tolerability and cost.

Bisphosphonates should not be used routinely to prevent osteoporosis in men with prostate cancer receiving androgen withdrawal therapy.

Strontium-89 should be considered for men with hormone-refractory prostate cancer and painful bone metastases, especially those men who are unlikely to receive myelosuppressive chemotherapy.

Decompression of the upper urinary tract by percutaneous nephrostomy or by insertion of a double J stent should be offered to men with obstructive uropathy secondary to hormone-refractory prostate cancer.

The option of no intervention should also be discussed with men with obstructive uropathy secondary to hormone-refractory prostate cancer and remains a choice for some.

Palliative care

Men with metastatic prostate cancer should be offered tailored information and access to specialist urology and palliative care teams to address the specific needs of men with metastatic cancer. They should have the opportunity to discuss any significant changes in their disease status or symptoms as these occur.

The regular assessment of needs should be applied systematically to men with metastatic prostate cancer16.

Palliative interventions at any stage should be integrated into coordinated care, and any transitions between care settings should be facilitated as smoothly as possible.

Healthcare professionals should discuss personal preferences for palliative care as early as possible with men with metastatic prostate cancer, their partners and carers. Treatment/care plans should be tailored accordingly and the preferred place of care should be identified.

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.

A decision aid for men with localised prostate cancer is in development in the UK by the Urology Informed Decision Making Steering Group (publication expected 2008).

Prostate Cancer Risk Management Programme (2006) Undertaking a trans-rectal ultrasound guided biopsy of the prostate. ISBN 9781844630417. Available from www​.cancerscreening.nhs​.uk/prostate/pcrmp01.pdf

Phase III randomised study of active surveillance versus radical treatment in patients with favorable-risk prostate cancer. Available from www​.cancer.gov/clinicaltrials​/CAN-NCIC-CTG-PR11

This may also apply to some men with locally advanced prostate cancer.

This may also apply to some men with locally advanced prostate cancer.

NICE interventional procedures guidance 130, 230 and 259 evaluated the safety and efficacy of cryotherapy and high intensity focused ultrasound for the treatment of prostate cancer. NICE clinical guidelines provide guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. As there was a lack of evidence on quality of life benefits and long-term survival these interventions are not recommended in this guideline.

This may also apply to some men with locally advanced prostate cancer.

estimated using the Roach formula: %LN risk = 2/3 PSA + (10x [Gleason score − 6])

NICE interventional procedures guidance 130, 230 and 259 evaluated the safety and efficacy of cryotherapy and high intensity focused ultrasound for the treatment of prostate cancer. NICE clinical guidelines provide guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. As there was a lack of evidence on quality of life benefits and long-term survival these interventions are not recommended in this guideline.

At the time of publication (February 2008) bicalutamide did not have UK marketing authorisation for this indication. Informed consent should be obtained and documented.

These recommendations are from ‘Docetaxel for the treatment of hormone-refractory metastatic prostate cancer’ (NICE technology appraisal guidance 101).

‘Improving supportive and palliative care for adults with cancer’. NICE cancer service guidance (2004).

Footnotes

1

A decision aid for men with localised prostate cancer is in development in the UK by the Urology Informed Decision Making Steering Group (publication expected 2008).

2

Prostate Cancer Risk Management Programme (2006) Undertaking a trans-rectal ultrasound guided biopsy of the prostate. ISBN 9781844630417. Available from www​.cancerscreening.nhs​.uk/prostate/pcrmp01.pdf

3

Clinical stage T3-T4 represents locally advanced disease.

4

Phase III randomised study of active surveillance versus radical treatment in patients with favorable-risk prostate cancer. Available from www​.cancer.gov/clinicaltrials​/CAN-NCIC-CTG-PR11

5

This may also apply to some men with locally advanced prostate cancer.

6

This may also apply to some men with locally advanced prostate cancer.

7

NICE interventional procedures guidance 130, 230 and 259 evaluated the safety and efficacy of cryotherapy and high intensity focused ultrasound for the treatment of prostate cancer. NICE clinical guidelines provide guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. As there was a lack of evidence on quality of life benefits and long-term survival these interventions are not recommended in this guideline.

8

This may also apply to some men with locally advanced prostate cancer.

9

For example RADICALS (www​.ctu.mrc.ac.uk/studies/PR10.asp)

10

For example RADICALS (www​.ctu.mrc.ac.uk/studies/PR10.asp)

11

estimated using the Roach formula: %LN risk = 2/3 PSA + (10x [Gleason score − 6])

12

For example RADICALS (www​.ctu.mrc.ac.uk/studies/PR10.asp)

13

NICE interventional procedures guidance 130, 230 and 259 evaluated the safety and efficacy of cryotherapy and high intensity focused ultrasound for the treatment of prostate cancer. NICE clinical guidelines provide guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. As there was a lack of evidence on quality of life benefits and long-term survival these interventions are not recommended in this guideline.

14

At the time of publication (February 2008) bicalutamide did not have UK marketing authorisation for this indication. Informed consent should be obtained and documented.

15

These recommendations are from ‘Docetaxel for the treatment of hormone-refractory metastatic prostate cancer’ (NICE technology appraisal guidance 101).

16

‘Improving supportive and palliative care for adults with cancer’. NICE cancer service guidance (2004).

Copyright © 2008, National Collaborating Centre for Cancer.

No part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licenses issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

Bookshelf ID: NBK49515
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