INDIAN WELLS, Calif., June 16, 2020 /PRNewswire/ -- HALO Diagnostics released interim 10-year results from its Phase II 20-year clinical trial for prostate laser focal therapy in patients with localized prostate cancer. 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: less than 1% infection, less than 1% erectile dysfunction and less than 1% incontinence – compared to conventional whole gland prostatectomy which has a risk of up to 50% erectile dysfunction and 25% urinary incontinence. These results, along with a 100% prostate cancer-specific survival rate, are an encouraging development for men looking for a prostate cancer therapy option with a lower risk of side effects.
Why is this study important to prostate cancer patients? "Magnetic resonance image (MRI)-guided laser focal therapy enables doctors to contour their approach to the areas of the prostate that needs to be treated, while creating safety boundaries around the areas that need to remain untouched," said Bernadette M. Greenwood, chief research officer of HALO Diagnostics. "This level of precision compared to other approaches, such as radical prostatectomy, radiation therapy and even other focal or targeted approaches like high-intensity focused ultrasound (HIFU), substantially lowers the risk of side effects, including urinary incontinence, impotence and decreased bowel function. Unlike other treatments, laser focal therapy does not limit the option to treat with radiation therapy or surgery if needed later."
The procedure is as follows: the laser focal therapy (also called LITT or FLA) is designed to destroy prostate tissue under MRI guidance using laser energy. The laser device is FDA 510(k) cleared for clinical use for soft tissue necrotization. The planning system is FDA 510(k) cleared for MRI-guided prostate biopsy. HALO Diagnostics is the first company in the world to combine these devices under IRB approved clinical trial NCT 02243033. The procedure is minimally invasive and ambulatory outpatient – no general anesthesia required.
"The purpose of this research, which began on May 24, 2010, is to investigate the safety and effectiveness of using MRI-guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years," said Dr. John Feller, chief medical officer of HALO Diagnostics. "The interim Phase II results indicate a paradigm shift in the treatment of men with intermediate risk prostate cancer and those with biochemical recurrence. These results are not only an exciting development in the advancement of laser focal therapy for prostate cancer, but speak to the strength of our clinical team and our commitment to developing life changing patient experiences and outcomes."
Recruitment for the "Phase II Study to Evaluate Outpatient Magnetic Resonance Image-Guided Laser Focal Therapy for Prostate Cancer, a 20-Year Survival Study" will continue through the HALO Diagnostics' Center of Innovation in Indian Wells and conclude once the study goal of 200 men has been achieved and evaluated for oncological control for a 20 year period. The trial details are listed on clinicaltrial.gov and the 10-year interim results were published in Journal of Urology on May 15, 2020.
SOURCE HALO Diagnostics