Background: Until recently, newly diagnosed PCa (prostate cancer) patients often had an “all or nothing” choice. Assuming there was no evidence of spread outside the capsule, the patient was told that he could have either: (1) “definitive treatment”, which includes prostatectomy or some type of radiation; or (2) Active Surveillance, which entails monitoring the situation indefinitely. For men with more aggressive PCa, the Option 1 would be suggested, perhaps in some combination with Androgen Deprivation Therapy. For patients who appear to have low risk factors including Gleason Score 6, Option 2 Active Surveillance might be considered.
What about men with low-to-intermediate risk? The Prostate Cancer Intervention Versus Observation Trial (PIVOT) has showed no statistically significant improvement in longevity, based on 12 years follow-up. "The chance of recurrence is significant according to the meta-analysis of 31,000+ prostate studies performed by the Prostate Cancer Results Study Group, chaired by Peter Grimm, DO, Seattle, WA.”And there is almost certain reduction in Quality of Life due to risks of impotence, wearing pads and other side effects and complications. Clearly, Option1 is over-treatment for these men.
But what about Option 2? The Urologist is often not supportive, and there is fear that AS could lead to progression and metastasis. So, Option 2 is viewed by many as Under-treatment.
Recently, there is heightened interest in focal treatments that address the middle ground. Is there is a safe and effective approach to treating current clinically significant lesions and preserving the rest of the prostate? If so, could it be done with no or minimal risk of side effects and complications? And if PCa should return down the road, what are the future treatment options including focal, or if needed surgery, radiation and other treatments?
Fortunately, recent advances in 3T multiparametric (mp) MRI technology are being used for both diagnosis and treatment. FLA is performed inside an MRI machine and utilizes a laser to ablate the lesion(s) and thermometry to monitor adjacent healthy tissue that is preserved. There are a number of successful clinical trials that have been completed or are in process at the National Institute of Health, the University of Chicago, UCLA, Desert Medical Imaging, and the University of Toronto. Also, FLA has been approved for commercial use in the US. Leading Centers include the University of Texas Medical Branch - Galveston (Eric Walser, MD) and the Sperling Prostate Cancer Center - with locations in New York City and Florida (Dan Sperling, MD).
New Survey: In addition, a Survey, not a clinical Trial, was just completed of 100 patients who have had FLA: “A Healthcare Actuary’s Survey of 100 Focal Laser Ablation Patients” [show link to a URL]. The key findings of this survey include:
1) Patients want a treatment option that preserves future options and has minimal side effects. This alternative to doing “all or nothing” is a transformational paradigm shift..
2) Patients are well educated, higher socio-economic group, and have low-to-intermediate risk
3) 95% of patients are in retail setting and 5% are in investigational clinical trials
4) Only 15% initially learned about mp MRIs from a physician
5) 99% report MRI and Guided Biopsy are effective with no or minimal side effects
6) Only 6% initially learned about FLA from a physician
7) 99% would recommend FLA to a friend
8) 87% report FLA was effective and no recurrence
9) 81% report no significant Erectile Dysfunction (ED) and an additional 13% say it is too early to tell
10) 86% report no significant Urinary Dysfunction and another 6% say it is too early to tell
11) 94+% report they were able to resume their normal daily activities within a week … many within 1-2 days
12) What would they have done differently? 88% report nothing or little … with comments that they would skip the TRUS (also know as Random or Blind) Biopsy.
Lead author: John Fortin, Healthcare Actuary in Atlanta, GA. Design and review assistance: Wayne Williams and Henry Oat. All three men are FLA patients. Mr. Williams was the second prostate FLA patient in the US in 2009. The procedure was successful with no recurrence or any side effects or complications. Cost of procedure varies anywhere from about $15,000 to over $30,000 and is still generally considered “Experimental and Investigational” by carriers.