| AN
EVALUATION OF HEMI-ABLATION THERAPY USING HIGH-INTENSITY
FOCUSED ULTRASOUND (HIFU) IN THE TREATMENT OF LOCALISED
ADENOCARCINOMA OF THE PROSTATE.
Hashim Uddin Ahmed, (Clinical Research Fellow and Specialist Registrar in Urology), Mark Emberton, (Reader in Interventional Oncology and Honorary Consultant Urologist). Institute of Urology, London |
 |
Summary of Work
The hemiablation clinical trial is treating men who have prostate cancer
on just one side by destroying just that half only using high intensity
focused ultrasound (HIFU). This treatment uses soundwaves to
destroy the prostate tissue without the need for any needles or cuts
to the skin. The treatment is usually a daycase procedure. We
are trying to show whether we can reduce the amount of side-effects
(such as impotence, incontinence, rectal problems) that men experience
from traditional treatments (radical prostatectomy or radiotherapy).
In order to prove that men have cancer on just one side, the trial is
using state-of-the-art MRI scans and a biopsy technique that ‘maps’ the
prostate accurately. Only when these show that there is definitely
cancer on one side only, is the man eligible for continuing on to the
half-gland treatment. We are looking to treat 20 men and follow
them up for at least 12 months, although they will continue to be followed
up after that time under the NHS.
B. Other Agencies involved
| 1. Cancer Research UK Feasibility Study Committee. |
| 2. National Cancer Research Network |
| 3. Clinical Trials Unit Dr Jan van der Meulen (Clinical Effectiveness Unit, The Royal College of Surgeons of England). |
C. Trial Recruitment
| 15 men have proven cancer on just one side and have had hemiablation HIFU treatment. | |
| 15 men were shown to have cancer on both sides and have therefore been withdrawn from the trial. | |
| One man had no cancer on the prostate mapping biopsies and has been withdrawn from the trial. | |
| One man was withdrawn from the trial prior to template biopsies due to MRI detecting T3 disease. | |
| Six men have reached 6-month follow-up. |
Side-effects:
- Potency: 100% preservation of erectile function (3 men requiring phosphodiesterase
inhibitors for partial erections).
- Incontinence: 0% (no stress urinary incontinence, no urge incontinence)
- Other: 2x UTI post hemi-HIFU (one patient did not complete antibiotic
course after treatment)
Early cancer control:
- 6 men at 6 months have had TRUS biopsies for verification of cancer
destruction. 100% negative biopsies
- PSA kinetics: all men have demonstrated a drop of PSA at 1 month
of 66%. This decrease has been maintained at all follow-up visits
so far.
On the basis of these early encouraging results, we are confident that
a phase III trial should be developed.
Although recruitment has been slower than anticipated, we expect to
complete the full 20 patient recruitment within the next 6 months.
D. Presentations
A discussion of focal therapy has been accepted by Nature Clinical Practise
Oncology (IF 5.6) and is in print. A copy can be supplied on request.
International poster/presentations
- Ahmed HU, Kirkham A, Freeman A, Illing RO, Allen C, Emberton
M; An evaluation of hemiablation for unilateral prostate cancer using
high intensity focused ultrasound. International Society for Therapeutic
Ultrasound, Oxford, 30/8/06, 2006.
- Ahmed HU, Emberton M; Focal Therapy in Prostate Cancer – refining
the questions, defining the problems. HIFU meeting, AUA Annual
Meeting, Atlanta, USA, 2006.
National Presentations
- Ahmed HU;; The role for focal therapy in prostate cancer.
- Ahmed HU, Emberton M; EAU 2007. 23rd March 2007. HIFU Meeting. Early results
from Hemi-HIFU trial.
- Zacharakis E, Ahmed HU, Illing RO, Emberton M; PSA kinetics
after whole-gland HIFU treatment
for localised prostate cancer. EAU
2007. HIFU Meeting, 23rd March 2007.
- Focal therapy in the treatment of localised prostate cancer – is
it possible? A VISION OF THE FUTURE FROM - MY LOUNGE CHAIR. 6th October
2006. St Bartholomew’s Hospital, UK.
Regional and Hospital/University Presentations
- Ahmed HU, Emberton M; Can High Intensity Focused Ultrasound be used in the focal treatment of prostate cancer. European HIFU User Group, London, UK (18/1/2006).
Mark Emberton has also been honoured with the Golden Cystoscope Award by the British Association of Urological Surgeons in the 2007 Annual Meeting for his contribution to the research field of prostate cancer.
E. Layman’s Summary
The choice for men who have prostate cancer that has not spread outside the gland is between active surveillance and treating the whole gland with surgery or radiotherapy. Active surveillance involves monitoring the disease using blood tests and repeated biopsies every 2-3 years. Treatment is given only if the cancer shows signs of progressing. The benefit of whole-gland treatment in reducing the risk of dying from cancer is 5% or less within 10 years. However, treatment carries risk of incontinence, impotence and rectal problems. These occur because treating the whole gland leads to damage to structures immediately surrounding the prostate
This programme of research aimed to find out if prostate cancer management can be developed in a similar way to how breast cancer treatment changed two decades ago. Women usually had to undergo an operation to remove the whole breast whereas currently, most women undergo a lumpectomy of only the cancer. This trial is looking at a similar principal in prostate cancer. In other words, in men with prostate cancer that is located to only one side, can we destroy only that side and achieve lower side-effects? At the same time, can we maintain good cancer control. We treated 15 men and so far all have had excellent return of erections (100%, although 3 have required viagra or viagra like tablets) and no incontinence. The PSA drops by about two-thirds in all the men, but because half the gland is still intact, we do not expect a similar outcome to radical surgery or radiotherapy. These are very promising early results. We need to complete the follow-up of these men to at least one year after treatment and if this shows good results, we can run a larger multicentre trial looking at longer follow-up.
Another outcome of these findings is that a focal-HIFU trial evaluating the toxicity of treating just the areas of cancer in men who have bilateral disease has been set up. This trial is not part of the grant kindly given by Prostate Research Campaign UK, but forms an inherent part of the research programme, whilst also demonstrating a further output from our group.
Final research report dated 05 September 2007
Project 2005/16 and its extension 2006/01