Focal therapy using high-intensity focused ultrasound for localised prostate cancer

Interventional procedure consultation document

Focal therapy using high-intensity focused ultrasound for localised prostate cancer

Treating prostate cancer using high-intensity ultrasound delivered to targeted areas of the prostate

The prostate is a small gland near a man's bladder. Symptoms of localised prostate cancer include difficulties in passing urine, although the disease is often diagnosed before symptoms develop. Focal therapy using high-intensity focused ultrasound aims to find and destroy only the cancerous parts of the prostate, avoiding treatment of healthy tissue. High-intensity ultrasound is delivered to the tumour areas, which are destroyed through heating. The procedure aims to lower the risk of side effects that can occur when radical treatment is given to the whole of the prostate gland (such as loss of bladder control and sexual function).

The National Institute for Health and Clinical Excellence (NICE) is examining focal therapy using high-intensity focused ultrasound for localised prostate cancer and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about focal therapy using high-intensity focused ultrasound for localised prostate cancer.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

  • comments on the provisional recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence, with bibliographic references where possible

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

  • The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination and promote equality and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 20 December 2011

Target date for publication of guidance: March 2012

1   Provisional recommendations

1.1   Current evidence on the safety of focal therapy using high-intensity focused ultrasound (HIFU) for localised prostate cancer shows no major concerns. However, evidence on efficacy is limited in quantity and there is a concern that prostate cancer is commonly multifocal. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2   Clinicians wishing to undertake focal therapy using HIFU for localised prostate cancer should take the following actions.

  • Inform the clinical governance leads in their Trusts.
  • Ensure that patients and their carers understand the uncertainty about the procedure’s efficacy and the risks to sexual and urinary function, and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/guidance/IPGXXX/publicinfo). [[details to be completed at publication]]
  • Clinicians should enter details about all patients undergoing focal therapy using HIFU for localised prostate cancer onto the British Association of Urological Surgeons (BAUS) cancer register (www.baus.org.uk) and review clinical outcomes locally.

1.3   Patient selection and treatment should be carried out by a multidisciplinary urological cancer team.

1.4   NICE encourages further research into focal therapy using HIFU for localised prostate cancer. This should take the form of controlled studies comparing the procedure against other forms of management. Studies should clearly define patient selection criteria and should report long-term outcomes.

2   The procedure

2.1   Indications and current treatments

2.1.1   Symptoms of localised prostate cancer include difficulty in passing urine, although the condition is often diagnosed at an asymptomatic stage.

2.1.2   Treatment options for patients with localised prostate cancer include active surveillance, radical prostatectomy, external beam radiotherapy, brachytherapy, and ablation of the whole gland using cryotherapy or HIFU. All radical treatment options are associated with substantial risks of sexual, urinary or bowel dysfunction. Focal therapy using HIFU is intended to be used in patients with localised prostate cancer – specifically patients with tumours that are confined to one prostatic lobe.

2.2   Outline of the procedure

2.2.1   Imaging and biopsy mapping studies are used to confirm that the tumour is suitable for focal therapy and to show its precise location. With the patient under local or general anaesthesia, the bladder is catheterised using a supra-pubic catheter and the HIFU probe is inserted transrectally. Real-time ultrasound imaging guidance is used to position the probe and to monitor the procedure. Pulses of HIFU are directed at the targeted part of the prostate, inducing tumour necrosis by a thermal effect and causing cavitation, (which can be visualised by ultrasound to assess the adequacy of treatment), until satisfactory ablation of the target area is judged to have occurred.

2.2.2   After treatment patients are usually followed up regularly with prostate-specific antigen (PSA) measurements and repeated biopsies to detect recurrence. 

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/839/overview

2.3   Efficacy

2.3.1   A case series of 12 patients reported overall and cancer-specific survival of 83% and 100% respectively at a median follow-up of 10.6 years. Recurrence-free survival was 90% at 5 years and 38% at 10 years.

2.3.2   In the case series of 12 patients, treatment failure (defined as any positive biopsy and/or need for salvage therapy prompted by rising PSA levels) was observed in 42% (5/12) of all patients. In 1 patient prostate cancer was managed by further focal HIFU treatment and in 4 patients by androgen deprivation. All 5 patients were alive at follow-up between 9.5 and 11 years.

2.3.3   In a case series of 20 patients, 10% (2/20) of patients had magnetic resonance imaging (MRI) findings suggestive of low volume recurrence of disease. One patient opted for active surveillance and the other was re-treated with focal HIFU. In case series of 12, 29 and 20 patients, there was no histological evidence of cancer in 92% (11/12), 77% (13/17) and 90% (17/19) of patients respectively at 12‑month follow-up.

2.3.4    In the case series of 29 patients, median PSA levels decreased from 5.36 ng/mL before treatment to 3.42 ng/mL and 1.52 ng/mL after 2 and 3 years respectively. In the case series of 20 patients, mean PSA level decreased by 80% after treatment.

2.3.5   The Specialist Advisers listed key efficacy outcomes for this procedure as biochemical disease-free survival, absence of viable cancer on repeat biopsy, and MRI evidence of cancer ablation.

2.4   Safety

2.4.1   The case series of 20 patients reported a decrease in erectile dysfunction score (using the International Index of Erectile Dysfunction scoring system on a scale of 0–30; lower value indicates worse function) from a mean of 20.9 points at baseline to 14.3 points at 1 month (p = 0.004). However, scores at 3, 6, 9 and 12 months were not significantly different from baseline (mean scores of 17.9 [p = 0.278], 21.7 [p = 0.705], 23.3 [p = 0.198] and 21.8 [p = 0.619] respectively). 95% (19/20) of patients had erectile function sufficient for penetrative sex at 12-month follow-up.

2.4.2   In the case series of 12 patients, 1 patient developed epididymo-orchitis and another had an asymptomatic urinary tract infection.

2.4.3   The Specialist Advisers listed adverse events reported in the literature as bladder neck stenosis acute retention and erectile dysfunction in those who are preoperatively potent.

2.5   Other comments

2.5.1   The Committee was mindful of the uncertain natural history of prostate cancer; this underpinned the recommendation for controlled studies and the need for details of long-term outcomes. 

2.5.2   The Committee noted the potential for this procedure to avoid many of the complications of more radical treatments for localised prostate cancer in properly selected patients, if further evidence supports its efficacy.

2.5.3   The Committee noted a number of patient commentaries which described benefits from the procedure, but which reported occasional cases of urinary and sexual dysfunction.

3   Further information

3.1   For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

October 2011

Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.

 It is the responsibility of consultees to accurately cite academic work in order that they can be validated.

This page was last updated: 21 December 2011