Salvage focal ablative therapy for radio-recurrent prostate cancer is safe and provides good short to medium-term oncological control

June 3, 2020

This is a press release from Sonacare Medical and


SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, is pleased to report a new study that has shown that targeted treatment to areas of cancer inside a prostate previously treated for cancer using radiotherapy is effective and has low risk of side effects. The study was carried out in men in whom prostate cancer had recurred following radiotherapy. The study is to be presented at the international ASCO (American Society of Clinical Oncology) cancer meeting on 29th May 2020.

Every year, about 30,000 to 50,000 men with prostate cancer in the U.S. are treated with radiotherapy. This is an effective treatment for prostate cancer but about 30% of men will have evidence of recurrent disease within five years. Patients who have a cancer recurrence contained within the prostate are traditionally offered anti-testosterone hormone treatment. While effective at limiting the disease, it does not eliminate the disease and must be taken for life in lieu of another intervention. Courses of hormone treatment can cause side effects such as obesity, tiredness, and bone thinning, and can also increase the risk for diabetes and heart disease. An alternative is radical salvage surgery (called salvage prostatectomy) which removes what is left of the prostate after radiation. This procedure is difficult to perform after radiation therapy because the tissues surrounding the prostate are scarred and stuck down secondary to the radiation. Among men who receive a salvage prostatectomy, 50-100% get urine leakage needing daily pads and 5-10% get rectal injury that may require a colostomy or other major reconstructive surgery.

Focal therapy uses different forms of energy, noninvasively or minimally invasively, to target and treat selectively only those regions of the prostate where cancer has recurred. The form of energy used by Sonablate is high intensity focused ultrasound (HIFU). Unlike prostatectomy surgery, HIFU is delivered without incisions. Most men go home the same day pain free and are back to work within several days; this is weeks to months sooner than what is seen with a salvage prostatectomy.

At 356 patients, this current study is the largest ever and with the longest follow-up to come out of the UK. At six years, 3 out of 4 patients treated with focal therapy had their cancer controlled and did not need hormones or surgery. Cancer specific survival was 97.2%. The procedure is also safe; less than 1 in 100 patients had a significant complication. Rectal injury was 0.3% while the researchers have shown in another study that urine leakage needing pads after salvage HIFU was only 12.5%.

Professor Hashim Ahmed, senior researcher for this study, which was performed at Imperial College NHS Foundation Trust and Imperial College London, said that, “Radiotherapy is effective in most men but for the thousands of men with recurrent prostate cancer after radiotherapy, the options are very limited. Focal therapy for these patients offers a treatment for their cancer that does not carry the high risk of side-effects from traditional hormones or major surgery.”

Dr. Deepika Reddy, a urology research doctor, and lead author on the study, based at Imperial College NHS Foundation Trust and Imperial College London, said, “This study provides more evidence that focal therapy should be considered in men whose cancer is suitable for a minimally-invasive approach. Such evidence in combination with well-structured clinical trials will help patients, in partnership with their doctors, work out the most suitable option for them.”

Dr. Mark Carol, SonaCare Medical CEO and President, said, “One of the first clinical uses for Sonablate HIFU in the U.S. was for the treatment of recurrent prostate cancer status post radiation therapy. The U.K. has taken the lead in developing and demonstrating the value of HIFU for many stages of prostate cancer. This paper continues the amazing track record Professor Ahmed and his team have established in proving and promoting the value of HIFU.”

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