MRI-guided laser focal therapy showed a better safety profile than standard treatments for patients with localized prostate cancer.
MRI-guided laser focal therapy manufactured by HALO Diagnostics showed tremendous precision and fewer side effects than standard treatment options in patients with localized prostate cancer, according to interim 10-year results from a phase 2 trial.1
The procedure yielded a 100% prostate cancer–specific survival rate. The safety profile showed that the rates of erectile dysfunction, infection, and incontinence were all under 1% with MRI-guided laser focal therapy. These rates show a tremendous benefit over standard whole-gland prostatectomy, which is associated with a 25% risk of urinary incontinence and 50% risk of erectile dysfunction.
"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," John Feller, MD, chief medical officer of HALO Diagnostics, stated in a press release.
"The interim phase 2 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," added Feller.
At this analysis, the study included over 170 men with low-to-intermediate risk or recurrent prostate cancer who volunteered to enroll. Inclusion criteria were aged ≥45 years; clinical stage T1c or T2a; Gleason score of 7 (3+4 or 4+3) or less; ≤3 biopsy cores with prostate cancer; and a PSA density of ≤0.375. At the 10-year follow-up, the overall survival rate was 98%, the prostate cancer–specific survival rate was 100%, and the metastasis -free survival rate was 99%.2
According to HALO Diagnostics, recruitment on the 20-year, phase 2 study will continue until “The study goal of 200 men has been achieved and evaluated for oncological control for a 20-year period.”
The technology used in the study combines a laser focal therapy device with a planning system device for MRI-guided prostate biopsy. Both pieces of equipment have FDA 510(k) clearance for use in this setting.
“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," Bernadette M. Greenwood, chief research officer of HALO Diagnostics, stated in the press release.
"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, 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," added Greenwood.
1. HALO Diagnostics Interim Data from Clinical Trial Shows Groundbreaking Results for New Prostate Cancer Treatment. Published June 16, 2020. https://prn.to/2YJDcsE. Accessed June 16, 2020.
2. Feller J, Greenwood B, Jones W, et al. Outpatient trans-rectal MR-guided laser focal therapy phase II clinical trial: ten-year interim results. American Urological Association 2020 Virtual Science Session. PD17-01.