Laser Focal Therapy – 10 Year Phase II Clinical Trial Results

HALO Diagnostics is proud to report the first 10 years of results for a clinical trial on the efficacy of MRI-guided laser focal therapy. Over 170 men, 45-years or older diagnosed with low-to-intermediate risk or recurrent prostate cancer, volunteered to participate in the study.

The results are impressive, and offer a much needed, less-invasive treatment option for men. The results show a prostate-cancer specific survival rate of 100%, and an extremely low incidence (less than 1%) of side effects, such as erectile dysfunction, infection and incontinence.

Prostate cancer is the second leading cause of cancer death in men in the United States. More than 33,000 men will die from the disease this year, making it just as deadly for men as breast cancer is for women.

One of the most common treatments for prostate cancer is called whole gland prostatectomy—the surgical removal of the prostate gland—and carries a very high risk for unpleasant and long-term side effects, such as pain, infection, erectile dysfunction and urinary incontinence. Another common treatment is radiation therapy, which also has a high risk of sexual dysfunction, as well as bowel problems and fatigue.

“Conventional whole gland prostatectomy and radiation therapy carry significant risks for patients that can negatively impact their quality of life,” said Bernadette M. Greenwood, chief research officer of HALO Diagnostics. “This treatment offers an excellent and proven alternative to surgery or radiation with a much lower risk.”

MRI-guided laser focal therapy (also called LITT or FLA) is a precise treatment that enables doctors to “contour” their approach to only those areas of the prostate that need to be treated, while creating safety boundaries around healthy tissue. Unlike other treatments, laser focal therapy does not limit the option to treat with radiation therapy or surgery if needed later.

“This is a true paradigm shift in the treatment of men with intermediate risk prostate cancer and those with biochemical recurrence,” said Dr. John Feller, chief medical officer of HALO diagnostics. “The 10-year results will elevate laser focal therapy to the top of the less-invasive treatment options for the majority of men with prostate cancer who need treatment.”

The trial details are listed on clinicaltrial.gov and the 10-year interim results were published in Journal of Urology on May 15, 2020.