Contributed by John McLean, Chief Operations Officer, HIFU Prostate Services

Over Treating

Prior to the 2012 guidance of the US Preventive Services Task Force (USPSTF) there was a growing consensus among urologist that prostate cancer was being over treated. The problem was that when men were diagnosed with low grade prostate cancer, they were undergoing aggressive treatments such as surgery, radiation therapy and hormone therapy that often led to a long list of side effects, such as: impotence, incontinence and bowel dysfunction. Drastically diminishing the quality of life and leading to additional medical procedures.  Some people described it as, using a sledgehammer to crack a single nut. It seems irrational to cause that much collateral damage if it is not needed.

This debate centered on the fact that some of these patients could have done better by doing nothing except, monitoring the disease for changes or tumor growth, also known as active surveillance. However, there was no clear process for determining which patients were the best candidates for active surveillance.  Physicians know that prostate cancer is a slow growing disease, but they lack the proper tools and resources to be able to know how individual patients were presenting with the disease. It isn’t the same in every person, and unless they can specifically diagnose where the cancer is in the prostate and how aggressive it is, then they are not equipped to recommend who is a good candidate for active surveillance and who is not.  

Some urologists developed nomograms that included PSA, Gleason, and tumor stage to grade the cancer as low risk, intermediate risk, and high risk. They would then take that information to decide which treatment option was right for the patient. But even with this information, it’s not always a clear answer on the best way to proceed.

So, men are faced with a question when they are diagnosed with prostate cancer: “Do I pursue a treatment to eliminate the cancer in my body, knowing that the treatment could lead to significant side effects or do I take the risk of doing nothing at all and only intervene when (and if) absolutely necessary?”  

Do Not Screen

To complicate matters even more, in 2012, the USPSTF made a recommendation against prostate-specific antigen (PSA) based screening for prostate cancer. Their logic was based on research that said diagnosing prostate cancer by PSA led to men being over treated and thus, led to significant complications.

Not a single urologist is on the USPSTF, nor was a urologist consulted while they were reviewing this issue and making a recommendation. The USPSTF used the data of outcomes from clinical studies to justify their claim that, the benefits of PSA-based screening for prostate cancer do not outweigh the harm of treatment. This is a true statement for lower risk clinically insignificant disease who will do well on active surveillance, but it may be harmful for some men with clinically significant disease.

72% Increase

In July of this year, a study from Northwestern University  reported that there has been 72% increase in the new cases of advanced prostate cancer in the US. There has been a lot of criticism of this study, but it follows the trend any urologist in the U.S. will tell you they are seeing. While it is isn’t likely that the USPCTF’s recommendation had any effect on this increase since the timeframe of the study was 2004 to 2013 it still leaves a lingering question about the benefits or drawbacks of screening.  

Improvements in Screening and Treatments

Over the past decade there have been several changes in both screening and treatment of prostate cancer. On the screening side, new technology has emerged and become more widely available for diagnosing and detecting prostate cancer.  While the PSA test is still the leading indicator of whether there is a problem or not, more and more physicians are using MRIs, Fusion Biopsies, and Genetic Testing to more clearly understand a prostate cancer diagnosis. Unfortunately for some men, insurance companies are not willing to cover these new procedures and so they are still left without an option for the most effective screening possible.  

On the treatment side of things, there are now new non-invasive and targeted treatments, such as HIFU, that have similar effectiveness as traditional treatments, such as surgery and radiation, but have shown a reduction in the complication rates that the USPSTF had warned against. Additionally, due to the nature of HIFU energy, it can be incredibly targeted to only treat the cancerous tissue this eliminating risk of damage to other areas that lead to side effects. This is known as focal therapy and has been compared to a Male Lumpectomy. For the right patient, with proper diagnosis, focal therapy can offer cancer control with minimal, if any, side effects.  

Conclusion

In retrospect, we know that a properly diagnosed and stratified patient who is put in an active surveillance protocol appears to do very well. We also know that a patient that has been screened appropriately and treated appropriately does very well also. The problem the USPSTF has potentially created is a lack of screening which can lead to more men being diagnosed with later stage prostate cancer. Unlike when it is caught early, if men are diagnosed with a much higher grade symptomatic disease, they have fewer treatment options for controlling the cancer. This is costing these men the option of lower complication intervention for their disease. Some of these later stage diagnoses are too late for a curative treatment and often patients are subjected to chemotherapy and hormonal therapy which is only palliative and has significant side effects.

Our physicians strongly believe best practice is to begin prostate cancer screening protocol around the age of 45-50. Obviously, this is not a straightforward issue and the answer is not the same for every person. Men need to ask their doctors lots of questions and seek out second opinions if they don’t feel like they have been presented with satisfactory options for screening and treatment.

Talk to your physician at your next physical about screening for prostate cancer.   

About the Author:

As Chief Operations Officer, John McLean is responsible for managing several aspects of the company, including: marketing, operations, development, training and technology.  Prior to joining HIFU Prostate Services, McLean spent 8 years working for SonaCare Medical, the worldwide leader in HIFU technologies; the developer and manufacturer of the Sonablate HIFU system.

McLean has been a part of several hundred Sonablate HIFU procedures as a technician including a large portion of the clinical trial procedures. McLean is one of the most experienced HIFU engineers in the United States and has assisted in the training of several HIFU engineers, and over a hundred physicians for SonaCare Medical. Additionally, he was an integral part of the Sonablate team that recently launched the technology, after FDA approval, as a product manager for the Sonablate HIFU system.