MRI-Guided Focal Laser Therapy for Low-risk Prostate Cancer
Name of the Trial
MRI-Guided Focal Therapy in Prostate Cancer (NCI-11-C-0158). See the protocol summary.
Dr. Peter Pinto, NCI Center for Cancer Research
Why This Trial Is Important
Roughly 240,000 men will be diagnosed with prostate cancer in the United States this year. Most of them will receive their diagnosis after a prostate biopsy that was triggered by screening with the PSA test rather than by symptoms. Consequently, many of these men will have cancer that is confined to a small portion of the prostate gland (low-volume disease) and is likely to grow so slowly that it may never jeopardize their health (low-grade disease).
Management options for men with such low-risk prostate cancer include treatment and active surveillance, in which the cancer is monitored and treatment is delayed until there are signs of disease progression. Current treatment options include surgery to remove the prostate (radical prostatectomy) and radiation or ablation therapy to destroy the entire prostate gland. Although active surveillance may be recommended, most men seek immediate treatment.
Unfortunately, the available treatments target the entire prostate and often affect nearby nerves and muscles that help control urinary continence and erectile function. Because of the high likelihood of serious side effects and the typical slow course of prostate cancer growth, the U.S. Preventive Services Task Force recently recommended against routine PSA screening for men of any age. However, this recommendation has been questioned by many doctors and patient groups.
Given that PSA screening is unlikely to be abandoned in the short term and that many men diagnosed with low-risk disease will continue to seek treatment, researchers are eager to develop new approaches to treating low-volume, low-grade prostate cancer that carry less risk for serious side effects.
In this pilot study, which is being conducted at the NIH Clinical Center, men diagnosed with low-risk prostate cancer and men with suspected prostate cancer will undergo advanced magnetic-resonance imaging (MRI) techniques developed at NCI to visualize the prostate and tumor tissue in high detail and guide a biopsy to that area. The men will then be treated at a later date using MRI-guided focal laser ablation therapy to only the area of the prostate that has cancer. The study will assess the feasibility and safety of this therapy.
“Some of the recommendations against PSA screening are based on data from large clinical trials conducted in both Europe and the U.S. which found that, to save one life from prostate cancer, you have to treat many men who then may suffer the harms of treatment,” said Dr. Pinto. “We are trying to find a better way to treat prostate cancer without the side effects of traditional whole-prostate therapy.
“Our approach is to use focal therapy to treat only the area of the prostate where the tumor is. This involves inserting a laser fiber into the tumor nodule with MRI guidance, heating the tumor with a laser, and using MRI to watch in real-time as the heat from the laser destroys the tumor while leaving the remaining prostate gland intact and the surrounding nerves and muscles unharmed,” he explained.