As the chief medical officer of the Foundation, I am occasionally asked what I would do to manage prostate cancer if I were ever diagnosed with it. There are many factors to consider, including:
- The American Urological Association (AUA) guidelines;
- My Gleason Score, which is used to determine the aggressiveness of prostate cancer;
- Risk factors for incontinence and impotence; and
- The various treatment options available, including conventional surgery, robotic surgery, radiation therapy, and high-intensity focused ultrasound (HIFU).
Consider this hypothetical example: if I were diagnosed with low-risk prostate cancer (Gleason 3 + 3), I would be eligible to receive focal treatment – as opposed to hemi-ablation or whole-gland ablation. However, my physician would be unlikely to recommend any treatment, invasive or otherwise.
AUA guidelines state that, in this low-risk scenario, physicians should recommend “active surveillance as the best available treatment option.” That sounds simple enough and would fit with my desire to avoid the side effects of traditional interventions – namely, incontinence and impotence. So, that’s all I need to know, right?
Perhaps. But I am troubled by the knowledge that for almost every other type of cancer, it is important to diagnose it early and start treatment before it grows or spreads. Why are the recommendations different for prostate cancer? Well, upon further research, my conclusion is that prostate cancer is like other cancers: it is better to treat it early, because no one can accurately predict when or if it will grow or spread. So why is the AUA recommendation for active surveillance?
The simple answer is, that despite the variety of options, all of the treatment modalities carry an unacceptably high risk for major side effects – incontinence and impotence. In reality then, it is not that physicians necessarily want to leave prostate cancer untreated. It’s just that when the available treatment options carry such a high risk for significant side effects, the treatment could potentially be worse than the disease. This results in the recommendation of “active surveillance” for many of the lower risk patients.
This raises an important question: is there an alternative to traditional invasive treatments that might address prostate tumors with an acceptably low risk for these major side effects? According to US Preventive Services Task Force, a conventional radical prostatectomy results in an average of 20 percent incontinence requiring use of pads, and 66 percent erectile dysfunction. Radiation therapy results in 16 percent incontinence with long-term bowel symptoms (including fecal incontinence), and 50 percent have erectile dysfunction.
HIFU is mentioned in the guideline document. However, it comes with the qualifying statement that “these interventions [HIFU] are not standard of care options because comparative outcome evidence is lacking.” What this means is that there may be another option, but they are not certain if the results would be better or worse. Therefore, the recommendation committee cannot make a definitive statement due to lack of data.
But, allow me to take a look at some published results and make an early estimate of what the risks might be. Although published data are sometimes difficult to interpret due to differences in Gleason Scores, varying treatment protocols, and non-uniform, long-term follow-up periods, there are some important data points that make HIFU a reasonable alternative treatment.
As I began to read recent, peer-reviewed, published articles, I quickly gained a renewed respect for the folks that must make these kinds of recommendations. For one thing, the data sets contain different levels of Gleason Scores (Gleason 6-9). In addition, treatment specifics are different for each study (focal, hemi-ablation, or whole-gland ablation), and follow up is still short-term. It is clearly not an “apples to apples” comparison, which is why the AUA has not made an update to the recommendations. But, because my goal is to get a working estimate, it is still useful to examine the available information.
Looking at two 2019 focused ultrasound publications, both studies treated higher risk and more extensive disease than the focal 3+3 hypothetical diagnosis I proposed at the beginning. These studies likely overestimate the risk factors for focused ultrasound for someone who might receive an “active surveillance” recommendation.
|Study||Incontinence risk||Impotence risk||Treatments reviewed||Gleason score||Treatment types|
|Bass et al||1.4%||2.2%||166||6-9||Focal, hemi-ablation|
|Lei et al||8%||20%||86||6-8||Focal, hemi-ablation,
It is important to note that in the Bass study, 68 percent were focal treatments, while the rest were hemi-ablations. In the Lei study, only 14 percent were focal treatments, and the rest were hemi-ablations or whole-gland ablations. This difference in treatment type most likely accounts for the discrepancy between incidences of complications between the two studies.
These data suggest that the risks for focused ultrasound treatment are in the low, single-digit range – which is much better than the conventional treatment complication rates. With this in mind, a prostate cancer patient could visit a focused ultrasound physician and talk to them about a prognosis. Many physicians are keeping track of these data and could likely provide a more accurate prognosis and estimate than what is found in the above studies.
The biggest concern with choosing focused ultrasound treatment is that there still is not a lot of data, so you must look at results that are not exactly aligned with the existing data used by the AUA. Remember that a single physician’s unpublished estimate has not had the scrutiny and review process that typically accompanies publication in a major journal.
Ultimately, a prostate cancer patient must consider all available information and discuss it with his physician before deciding how to proceed. For me personally, it does appear that HIFU is an effective treatment option with an acceptably low risk, and I would seriously consider focused ultrasound treatment over active surveillance.
New CPT Code Established for EDAP’s Focal One Prostate Cancer Treatment
Prostate Cancer Trial Results Announced
Clinical Trials Combine Focused Ultrasound with Active Surveillance for Low-Risk Prostate Cancer
Prostate Cancer Treatment Insurance Coverage
Tim Meakem, MD, is the chief medical officer of the Focused Ultrasound Foundation.