Urology Times Innovation Celebration: Expert Insights - Episode 10
In this installment of the Urology Times' 50th Anniversary Innovation Celebration, Kara L. Watts, MD, discusses the emergence and increasing uptake of active surveillance as a management strategy for men with prostate cancer.
Urology Times® is celebrating its 50th anniversary in 2022. To mark the occasion, we are highlighting 50 of the top innovations and developments that have transformed the field of urology over the past 50 years. In this installment, Kara L. Watts, MD, discusses the emergence and increasing uptake of active surveillance as a management strategy for men with prostate cancer. Watts, a member of the Urology Times® Editorial Advisory Board, is an assistant professor of urology at Montefiore Medical Center, Bronx, New York.
Active surveillance is really a new approach to managing prostate cancer that arose in the beginning of the 2000s. But if you look back over time at what has happened with treatment for prostate cancer, it really traces all the way back to the early 1900s. In 1904, the very first perineal radical prostatectomy was performed at Johns Hopkins University. It wasn't until 1945 that the radical retropubic approach was introduced by Terrence Millin, MD.
Flash forward almost 40 years, where the modified technique for radical prostatectomy was introduced by Patrick C. Walsh, MD. The goal of this was to reduce bleeding and avoid injury to the neurovascular bundle. Around this time, in the early 1980s, is when the [prostate-specific antigen] PSA blood test was discovered as a screening test for prostate cancer. In the late 1980s, the first template for the transrectal ultrasound-guided prostate biopsy was developed, and so our ability to diagnose prostate cancer started to shift. At this point, all prostate cancers that were being diagnosed were being treated either with radical surgery, so an attempt to remove the entire prostate and seminal vesicles, or radiation therapy.
Flash forward about 15 years or so, in 2002, the very first report of active surveillance—it was called watchful waiting at the time—was published. It looked at the efficacy and the use of active surveillance, instead of actively treating a lot of these clinically localized, low-risk prostate cancers. This coincided with a lot of national data showing risks of the side effects associated with over treatment, but the detrimental effects of both surgery and radiation, particularly for low-risk, clinically localized disease.
There have been a number of studies that have looked at the uptake of active surveillance after it was first introduced in 2002. It really dramatically increased, mostly in the past 2 decades, but particularly after 2010. An analysis in the United States from the [Surveillance, Epidemiology, and End Results] SEER database, looked at data from 2010 to 2015, and at least across the United States, the rate of uptake in active surveillance went from single digits for low-risk disease to 40% to 50% on average. But what also emerged from this as well as other analyses is that there is really considerable variation in uptake by geographic region in the United States, but other factors as well, such as ethnic group, socioeconomic status, and other factors.
Beyond our national variation, there's also been a lot of variation by country in terms of the uptake and use of active surveillance. There are data from an analysis in Sweden examining the rates of active surveillance uptake for men with variable-risk disease, from the inception of active surveillance to a 6-year follow-up. The rates of active surveillance in Sweden went to 91% across the country for men with very low-risk disease 74% for those with low-risk disease, and even up to 19% for those with intermediate-risk disease. Our country has certainly had a boom in the adoption and uptake of active surveillance, but even with that we actually lag behind some European countries. Sweden is one example, but there are quite a few others that also have very high rates of uptake of active surveillance.
The other point I would make is that, in addition to the uptake and the widespread use of active surveillance for men with low-risk disease, a lot of our national organizations have guidelines supporting the use of this. Our own American Urological Association guidelines from 2017 gave a grade A, which is a strong recommendation that active surveillance should be recommended as the best available care option for men who have very low-risk disease and the preferable option for those with low-risk disease. This is a complete change from what we were doing even just 20 years ago.
In addition, the [National Comprehensive Cancer Network] NCCN also has been very much supporting this for the past decade. A lot of people reading this are probably aware of the social media explosion that happened in September 2021. Just a few months ago, the NCCN changed their recommendation of active surveillance as the preferred or standard option for low-risk disease, to state that it was no longer indicated as the preferred treatment for this particular group of men. Almost literally overnight, this sparked an outcry among urologists and researchers, and it blew up on Twitter. As a result, in December, the committee reconvened and updated their statement, again, to indicate that men with low-risk disease should be offered active surveillance as the only preferred treatment strategy. This is a tremendous difference and advancement compared to what we were doing 20 years ago, and certainly, in the last 50 years, if we're looking at how we've been treating and approaching prostate cancer.
Active surveillance is an innovation because it's truly a departure from the idea that all prostate cancers or cancer, in general, needs to be treated. This was really one of the first developments in the world of prostate cancer treatment that was done in an effort to avoid over treatment of men with prostate cancer, and in doing so, avoiding the potential side effects that are related to radical treatment but doing so in a way that was systematic with very vetted and well-studied and published data with long-term follow-up up to 20 years to ensure that we are offering appropriate recommendations for men and ensuring follow-up for them as well.
Interestingly, since active surveillance really took off, the pendulum of treatment for prostate cancer has continued to shift. If we think about prostate cancer treatment 50 years ago, and before that, it was all radical treatment, if men were even candidates for treatments of surgery, radical surgery, or radiation. Then the pendulum shifted for men with low-risk disease to introduce the concept of active surveillance and not treating, but actively following and monitoring their cancer, and the rates of that rose. Now, the other category of treatment, that is sort of in the middle, is focal therapy or "sub total" treatment, aimed at ablating or treating the prostate cancer lesion that's identified on MRI imaging, but not treating the entire prostate. This is being incorporated by some progressive institutions in their active surveillance protocols.
My practice is in the Bronx, New York. We work in a demographic with men from very low socioeconomic-status backgrounds and an extremely heterogeneous population—very ethnically diverse, at least 50% Black and/or Hispanic men. English is not the predominant language spoken in the boroughs where we treat our patients. We have to be mindful of some of these other factors that we know nationally affect implementation of active surveillance protocols. But in spite of this, the overall rates of using active surveillance by our faculty have more than doubled for the appropriate candidates in the past 5 years, and even more so if you look back going to 10 years. When I look at what we were doing from a protocol standpoint, when active surveillance was first being implemented here over a decade ago, we were really just using follow-up PSAs and biopsies when indicated and occasionally incorporating MRI prostate for imaging follow-up. But now that we know that the emergence of data supporting MRI prostates with MRI, ultrasound, fusion-guided prostate biopsies and incorporating fusion biopsies into surveillance protocols, we have incorporated that both in the initial diagnostic front, as well as in our surveillance follow-up for men for over 5 years now. We also have developed the concept of an adaptive active surveillance protocol, because not every man and not every cancer is exactly the same. So being a little bit adaptive in terms of the individual patient parameters, the risk factors, their family history, ethnicity, and clinical variables.