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Study Title: A Multi-Centre Prospective Single Arm Intervention Trial Evaluating Focal Therapy using High Intensity Focused Ultrasound (Sonablate 500) for Localised Prostate Cancer

Short Title: Focal Therapy for Prostate Cancer using HIFU

Acronym: INDEX

Prostate cancer is the most common type of cancer diagnosed in men in the UK. In most men, the prostate cancer has not spread outside of the prostate to other parts of the body. When this is the case, most patients are offered two main options, firstly a 'wait and see' policy which involves regular blood tests and re-sampling of prostate tissue (biopsies) to check whether the cancer is progressing and requires more 'active' treatment. The other choice is surgery or radiotherapy to treat the whole prostate. These treatments usually eliminate all of the cancer but also can cause side effects such as urinary leaking, impotence and bowel trouble.

Another potential option is to treat only the part of the prostate that contains the cancer, otherwise known as focal therapy. Results from earlier smaller trials have been promising, with the majority of men free of cancer and major side effects one year after focal therapy treatment. We now need to explore this idea in a larger group of men to confirm that this method can treat cancer in a safe and tolerable way.

The INDEX trial aims to treat 354 men within several centres that already use the type of treatment that we are planning. This is called HIFU (high intensity focused ultrasound), which uses ultrasound waves to heat and kill small areas of tissue, without damaging surrounding normal tissue. We will follow men up for two years after treatment within the trial, and over the long-term once the trial has finished (for up to 10 years). Men will receive periodic clinic visits with blood tests and questionnaires, then an MRI and biopsy of the treated area 1 year after treatment.

The INDEX trial asks the question: Can we successfully treat men with localised prostate cancer by reliably destroying the cancer areas that are clinically important, whilst not treating those areas that have no cancer or only clinically unimportant areas of cancer, using high intensity focused ultrasound (HIFU)?

Sponsor: University College London.

Funder: Sonacare Medical and University College London Hospital.

ClinicalTrials.gov Identifier: NCT01194648 https://clinicaltrials.gov/ct2/show/NCT01194648