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Clinical study

High Intensity Focused Ultrasound Focal Ablation in Prostate Cancer

Location of trial: University College London Hospitals NHS Trust, London, UK
Start date for recruitment: 1st July 2007
End date for recruitment: 1st July 2009
Number of men being recruited: 33

Aim of the trial

Men with localised prostate cancer (cancer that is only in the prostate) have to choose between two extremes of care - active surveillance versus radical therapy. Active surveillance involves no treatment but intensive monitoring with PSA and repeat biopsy – if there is any sign of progression then treatment is advised. Radical treatment involves destroying the whole prostate gland (usually surgery or radiotherapy).

This research project challenges the assumption that all men need to have their whole gland and the surrounding structures treated irrespective of the amount and location of their prostate cancer. Why can we not treat just the area with cancer and leave the rest of the gland alone? The concept is similar to that of ‘lumpectomy’ over mastectomy in breast cancer.

The researchers are looking at destroying just the areas of cancer in the gland using HIFU and leaving the other areas alone. They will then measure whether the treatment is associated with acceptable levels of cancer control and a very low rate of treatment-related side effects.

Criteria for inclusion in trial

You can enter this trial if you:

1. Have prostate cancer, Gleason score 7 or less, PSA 15ng/ml or less
2. Have cancer that is suitable for focal ablation, as determined by an MRI scan and transperineal template mapping biopsies (the research team will provide further details about this procedure)
3. Have a prostate gland that is suitable for HIFU in terms of size and consistency of the gland (the research team may need to perform a scan to determine this before recruitment)
4. Able to have MRI scans (no metal implants, no pacemaker)

You will not be able to take part if you have

1. Disease affecting more than half the gland or affecting areas close to the nerves that control erections
2. Disease which has spread beyond the capsule or to lymph nodes or bone
3. Disease with Gleason score greater than 7 (Gleason 7 is fine)
4. PSA greater than 15ng/ml
5. Had hormone therapy within the last 6 months
6. Had previous prostate surgery within the last 10 years

What does the trial involve?

Before entry into the trial, you will need to have had an MRI scan and further biopsies to find out exactly where your cancer is. HIFU treatment is a day-case procedure after which you will have a catheter to help you pass urine. After treatment, you will have a post-treatment MRI scan and have your catheter removed. Then you will have clinic visits at 1 month, 3 months, 6 months (this visit will involve transrectal biopsies of your prostate under local anaesthetic), 9 months and 12 months. After the trial period has finished, you will continue to be reviewed on a regular basis. At each visit there will be blood tests and questionnaires to fill in.

For further information, contact

Hashim Uddin Ahmed
Email: hashim.ahmed@ucl.ac.uk
Telephone: 02073805708

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