Geoff McLennan, MPA, Prostate Cancer Patient and Advocate – July 2023

Welcome back to my blog series on helping patients understand prostate cancer. I hope you’ve been doing well managing your Prostate Cancer (PCa) care, and that you feel confident about your treatment plan. If you are new to this blog, I encourage you to go through my earlier posts, as they contain valuable information. In this post, we will explore the use of biomarker tests in supporting your clinical care with doctors, specialists, and nurses. Let’s start by understanding what is meant by the term “standard of care” (SOC).

The term “standard of care” is used by insurance companies, doctors, nurses, medical plans, and state regulators. It varies depending on the illness, disease, or presence of multiple health conditions. For cancers, the National Cancer Institute defines SOC as “Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. Also called “best practice”, “standard medical care”, and “standard therapy”.

What are biomarkers in prostate cancer care?

Now, let’s dive into what biomarker testing entails and how it can aid in our understanding and management of prostate cancer. According to the National Cancer Institute, cancer biomarkers are “genes, proteins, and other substances (called biomarkers or tumor markers) that can provide information about cancer.” There are various biomarker tests available for PCa, including blood pressure, oxidative stress markers in blood , white and red cell count, heart rate, and blood and tissue tests to detect and measure lipids, hormones, and infections. Biomarker tests are important because they help doctors and specialists determine the status of disease, including cancer. Warning signs of cancer can involve bleeding, irregular lumps, or lesions in your body such as a lesion on the prostate and bone pain.  For example, with the prostate, since it is so far inside the body and difficult to reach, doctors use biomarker tests to identify if a disease such as cancer is present and if so, how advanced is it. Another very important use of biomarkers is to prevent critical organ failure such as the heart or kidneys by measuring enzymes in the blood. Biomarkers are lifesavers!

Testing also serves the purpose of screening for PCa in individuals without any symptoms or, if symptoms are present, to find the source of a symptom such as bleeding or frequent urination. Biomarkers are used to test for other cancers including cancers in the brain, colon, esophagus, liver, skin, and bone.

Genetic testing biomarkers

It is notable that genetic biomarker testing for certain cancers are available and can identify risk factors that help patients and doctors plan treatment before the cancer does significant damage. Myriad Genetics offers tests like the Prolaris® Prostate Cancer Prognostic Test that provides patients and their healthcare providers personalized information about the aggressiveness of their prostate cancer, and helps determine if patients are safe to forego treatment, in favor of active surveillance, or if they should pursue treatment and how much treatment is needed for the best possible outcome.

Different types of biomarker tests

There are two types of biomarker tests for PCa: non-molecular tests (which do not detect DNA and/or RNA) and molecular tests (which examine DNA and RNA). For a review of how RNA and DNA relate to cancer, see this link for a deep dive here. Non-molecular biomarker tests, such as PSA, 4K, and PSI Score, are crucial in your care even before considering a biopsy. Molecular biomarker tests, such as the Prolaris test mentioned earlier, are used in PCa care as they are more effective in screening new patients and helping doctors decide whether treatment is necessary or if active surveillance (AS) can be followed over an extended period. It’s important to consult with your doctor about which test to undergo and why. Non-molecular tests are primarily used for screening, while molecular tests can serve both screening and diagnostic purposes as recommended by your doctor.

How do healthcare providers use biomarkers?

Urologists and other specialists use these biomarker tests for various purposes, such as assessing the risk of PCa progression based on test results, determining the need for additional biopsies, assessing the need for treatment, and evaluating the success of a given treatment. For the purpose of this discussion, let’s assume that biomarker tests being considered for initial screening after a suspicious PSA or DRE test to confirm the presence of PCa, rather than for treatment choices including the active surveillance process. Now, you might wonder how biomarker tests fit into the “standard of care.” Let’s explore this question, as the answer is not straightforward.

So, let’s assume your urologist recommends the Myriad Prolaris test after your diagnosis of PCa. You might ask “why?” and the likely answer lies in the National Comprehensive Cancer Network (NCCN)® guidelines recommending genetic tests like these as SOC, pertaining to your PCa prognosis such as predicting likely outcomes for a treatment choice, like AS. There are two main categories of PCa diagnoses or status of disease: low risk, low grade patients with a Gleason score of 3+3 or grade group 1 & 2, and moderate to high-risk patients with a Gleason score of 3+4, 4+4, or higher and a grade group of 3-5. Now, let’s delve into biomarker testing and how it helps you and your doctor make decisions about your care with test results in hand.

It is essential for you to understand why your doctor selects a particular test and how it will benefit your care, whether it aligns with the NCCN guidelines or another SOC.

Biomarkers past and present

As a SOC for prostate cancer, biomarker tests have become much more than care. Years ago, before biomarkers and testing were available such as Prolaris, doctors only had the PSA test and DRE tests to screen and diagnose men for PCa and treatment. It is now understood that many men may have had unnecessary treatment including radiation and surgery that left them with harsh side effects. Biomarkers can also show providers and patient the risks of not treating and the benefits of treating based on more than just a PSA test. The added information from biomarker testing has created a higher SOC. Biomarker tests, like Prolaris has been meticulously reviewed and validated. As the old saying goes, “knowledge is power” and biomarker tests give you and your doctor the power of a biomarker fueled SOC.

Genetic testing cost coverage

You might ask who pays for the biomarker testing? Insurance companies, including Medicare, often cover testing based on NCCN or medical guidelines. Some patients with a commercial insurance plan might have coinsurance or deductible amounts to pay, but companies like Myriad often have financial assistance programs to help. When Medicare covers a test, you shouldn’t have an out-of-pocket cost. If cost is a hardship, Myriad offers financial assistance.

My biomarker test experience

My experience with two molecular biomarker tests went effortlessly and the results were very reassuring. My urologist requested the test using my biopsy samples before making his recommendation for my AS protocols. I am very grateful for these tests, my urologist, and the men’s support group, ASPI, which provided access to test information. The best news was that all my biomarker testing was 100% covered by insurance. Be sure to have your doctor, urologist and medical billing department confirm your level of coverage.

In summary, biomarkers and molecular tests are now vital components of your standard of care (SOC) for PCa. Biomarkers play a remarkable role in helping doctors protect patients from the risks associated with PCa and other cancers, preserving their bodies, lives, and the valuable time spent with family and friends. By sharing knowledge and nurturing relationships, we can make life a joyful experience. I hope this post has provided you with knowledge that will make your life with PCa more comfortable. Remember to wear sunscreen and a hat, support a balanced diet, and appreciate the availability of healthcare and biomarker testing.

Until we meet again, Voici pour vous!

Geoff McLennan, MPA, Prostate Cancer Patient and Advocate

Author Bio:

Geoff is dedicated to helping families and friends support a prostate cancer patient. He joined the board of Active Surveillance Patients International (ASPI) in 2018 and is an 11-year PCa patient. As a PCa patient advocate, he envisions providing a broad understanding of how patients can collaborate with clinicians for realistic medical care. He enjoys meeting and learning from his clinicians, cancer researchers, providing free online programs for patients, and reminds us that “to live, learn and thrive with PCa” is the motto of ASPI. He is glad he took science courses for understanding a healthy lifestyle that includes exercise and diet.

Geoff also volunteers as a board member and past chairman of the Placer County Mental Health Advisory Board where his interest includes therapy and resources for AS men, and a broad oversight of community mental health programs and innovations. He is married to Constance McLennan, a fine artist, has a grown son, and lives in Northern California.

*Disclaimer: The views expressed in this blog are solely those of the author, and do not represent the views or opinions of Myriad Genetics or its affiliates. It is important to consult with your healthcare provider.