Biomarker Testing Needed Before African American Patients Choose Active Surveillance

April 30, 2019

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By: Thomas A. Farrington
PHEN President

Prostate cancer treatment guidelines have undergone revisions in efforts to reduce over-treatment of men with low-risk prostate cancer by introducing active surveillance as a recommended approach. The objective being to reduce unnecessary treatments and related side effects where the cancer is not life threatening. However, for Black men studies show that what may appear as very low and low-risk disease could, in fact, be masquerading as more aggressive disease. This brings into question whether the new and revised guidelines for active surveillance are adequate for these patients.

At PHEN’s 2013 Annual African American (AA) Prostate Cancer Disparity Summit held in Washington, DC, Dr. Edward Schaeffer then at Johns Hopkins, and now Chair of Urology at Northwestern University, presented on findings from a study of men enrolled on active surveillance at Johns Hopkins1. These were some of the significant findings from this study:

  • AA men were more likely to progress on biopsy by either grade or volume, 69% vs 60%
  • AA more likely to experience progression by both grade and volume also, 39% vs 29%
  • AA experienced greater reclassification by grade, 36% vs 16%
  • After examination of surgical specimens of very low risk men who underwent radical prostatectomy, AA men were more likely to harbor dominant tumor nodules in the anterior part of their prostate, 51% vs 29%

Dr. Shaeffer’s conclusion was that African Americans with very low risk PC followed on active surveillance are at a significantly higher risk of grade reclassification of their tumor than Caucasians…Therefore, AA men may require alternate selection criteria specific to them.”

Dr. Brandon Mahal, Harvard Radiation Oncologist, presented at PHEN’s February 13, 2019 monthly meeting and webcast held at the Dana-Farber Cancer Institute on a study showing that black men with low-risk prostate cancer have higher mortality rates2. From this study Dr. Mahal observed that “African American men with Gleason 6 cancers are twice as likely to die from prostate cancer compared with non-African American men.” This study used the SEER (Surveillance, Epidemiology and End Results) and Prostate Active Surveillance/Watchful Waiting databases to analyze 192,224 men (31,841 black and 160,383 nonblack) with localized prostate cancer. Results showed that 0.4% of the black patients with Gleason 6 disease died compared with 0.22% non-black patients with Gleason 6 disease. The findings presented by Dr. Mahal seem to coincide with the findings outlined by Dr. Schaeffer.

In the U.S., data show that an increasing number of men with low-risk Gleason 6 prostate cancer are opting for active surveillance, but that option is used less frequently among black men. The question then becomes are these black patients saving themselves from an increased risk of death by not choosing active surveillance, or conversely, are they increasing their risk for unnecessary treatment side effects by choosing active treatment. I would submit that both are probably true where these patients are forced to blindly choose either option.

In referring back to Dr. Schaeffer’s conclusion that African American men may require alternate selection criteria specific to them I believe that such criteria should be explored with a sense of urgency. As more and more men are choosing active surveillance black men need a way to make a more informed decision on the best choice for them.

Since Dr. Schaeffer made his observation in 2013 there have been tremendous advances in the development and acceptance of genomic, i.e., molecular biomarker testing used to confirm the aggressiveness of cancer that biopsy tests show as “low-risk.” The National Comprehensive Cancer Network (NCCN) treatments guidelines include this risk stratification footnote: “men with low or favorable intermediate risk disease may consider the use of the following tumor-based molecular assays: Decipher, Oncotype DX Prostate, Prolaris, Promark. Retrospective studies have shown that molecular assays performed on prostate biopsy or radical prostatectomy specimens provide prognostic information independent of NCCN or CAPRA risk groups. These include, but are not limited to, likelihood of death with conservative management…” (Conservative management includes active surveillance)

Today, genomic (molecular) testing provides an opportunity to incorporate another level of risk confirmation on the aggressiveness of low risk prostate cancer. I am advocating that this testing be instituted as standard procedure for African American patients. This would become the alternate selection criteria to allow doctors to more accurately recommend either active surveillance or active treatment and provide the insight needed for African American patients to make an informed decision on treatment. Also, the NCCN guidelines include imaging as a tool for risk stratification for patients diagnosed with intermediate (Gleason 7) prostate cancer. I think imaging, especially magnetic resonance (MR) imaging should be used more liberally to accurately determine the true risk for African American patients diagnosed with low risk disease.

These approaches can save lives today for men who may choose active surveillance and don’t receive needed curative treatments timely; likewise, unnecessary treatments for men that may not need active treatment can be confirmed and eliminated. There certainly needs to be additional studies to better understand the overall factors contributing to the complexities of low risk prostate cancer in African American men, but actions that can be taken today should be taken.

References:

1 – Urology. 2015 Jan; 85(1): 155–160. Published online 2014 Oct 14.  doi:  10.1016/j.urology.2014.08.014  “Reclassification rates are higher among African American men than Caucasians on active surveillance”: Debasish SundiFarzana A FaisalBruce J TrockPatricia K LandisZhaoyong FengAshley E RossH Ballentine Carter, and Edward M Schaeffer

2 – JAMA. 2018;320(23):2479-2481. doi:10.1001/jama.2018.11716; Published December 18, 2018  “Prostate cancer specific-mortality across Gleason scores for black and nonblack men” Brandon A. Mahal, MD1; Rebecca A. Berman, MD2; Mary-Ellen Taplin, MD3; et al


Separate PSA Test Guidelines for High Risk and Average Risk Men Needed

November 6, 2013

Thomas A. Farrington, at PHEN's 2012 SummitProstate cancer early detection testing using the PSA test is one of the most controversial subjects in medicine today. This on-going controversy is not good for men who depend on their doctors to provide clear guidance for their prostate health. As a prostate cancer survivor and patient advocate I sometimes sense a lack of urgency to seek solutions to this controversy which is leaving patients confused and at times frantic about what to do. Make no mistake, these patients’ decisions will translate into life or death calls for some, and they deserve clear guidance.

I believe that leaders within the prostate cancer medical profession must work towards ending the PSA test controversy by embracing what is known and accepted while continuing to seek answers for the unknown. During the past two years we have witnessed the widespread acceptance of the concept of prostate cancer overtreatment and active surveillance, along with guidance to discontinue PSA testing for older men with a limited life expectancy. In my view this represents progress towards ending the controversy.

Another area of widespread acceptance is that African American and men with a family history of prostate cancer are at high risk for being diagnosed with the disease, and that African American men die at a rate 2.5 times greater than other men with prostate cancer. It is also well known and accepted by expert researchers in the field that these high risk men were not included in significant numbers within the randomized clinical trials that are the genesis for the ongoing controversy. It is well accepted that these high risk men have a great need for clear guidance on early detection testing. PHEN has taken steps to address this need.

PHEN’s “Consensus Statement on PSA Testing for African American Men for the Early Detection of Prostate Cancer” was presented at its “Annual African American Prostate Cancer Disparity Summit” on September 18th, 2013. This consensus statement is based on the “expert opinion” of the twenty three (23) prostate cancer medical experts who are signatories on it. Using this consensus statement PHEN has now published “Guidance on Early Detection Testing for Prostate Cancer for High-Risk Men” that can be clearly understood by laymen. PHEN’s Consensus Statement and Guidance targets African American and other high-risk men. However, PHEN was not the first organization to recognize the need, and take steps, to separate prostate cancer early detection guidance for average-risk and high-risk men.

The American Urological Association (AUA) released its updated early detection guidelines on May 3, 2013 with this statement: “It is important to note that the guideline statements listed in this document target men at average risk , defined as men without risk factors such as family history of prostate cancer in multiple generations and/ or family history of early onset below the age of 55 years, or African American.”

It is important to note that both the AUA and PHEN saw the need to separate their early detection guidance for the exact same reason; a lack of scientific evidence from the PSA screening trials for African American and other high-risk men. The AUA however, stopped short of providing any direct guidance for high-risk men. PHEN, on the other hand relied upon expert opinion to formulate its guidance; the only option available in the absence of scientific evidence. It is only responsible and humane to provide clear and direct guidance to the men most likely to be diagnosed with and die from prostate cancer. A failure to do so I consider gross negligence.

Widespread adoption of separate guidance for high-risk and average-risk men for prostate cancer early detection testing is clearly needed. In addition, this step will help end the ongoing controversy that currently engulfs us all. Towards these objectives I call upon the AUA, National Comprehensive Cancer Network, U. S. Preventive Services Task Force, American Cancer Society, State Cancer Control Commissions, and Prostate Cancer Patient Education and Advocacy Organizations to embrace PHEN’s Consensus Statement for the Early Detection of Prostate Cancer for African American and other High Risk Men.


PHEN Celebrates Ten Years!

February 6, 2013

This year PHEN is celebrating its Ten Year Anniversary! We have been on an exciting and productive journey during our first decade while paving a road for the future.

Secretary of State, John Kerry, alongside Congressman Gregory Meeks, stand in support of the fight against Prostate Cancer. Rev. Dr. Carroll A. Baltimore, speaks in favor of raising awareness for Prostate Cancer and the racial disparity among African American men.

Over Ten Years of outstanding work in the Fight Against Prostate Cancer

I was diagnosed with prostate cancer in 2000 and founded PHEN in 2003 to increase awareness and knowledge about prostate cancer within Black America which suffers an alarming 140% higher death rate than for all other men. There is a widespread void of knowledge and actions needed to address this deadly crisis.

PHEN’S first ten years has been dedicated to mobilizing a series of national initiatives aimed at filling this void. These initiatives are achieving impressive results and PHEN is now widely recognized as a leader in prostate cancer patient education and advocacy efforts. We celebrate PHEN’s accomplishments with a great sense of progress and excitement, and with a strong foundation of enduring and proven initiatives on which to enhance and expand our efforts for the work that still lies ahead.

PHEN Milestones and Initiatives (Click to Read) 

My sincerest appreciations to the many that supported PHEN, making our first decade possible and successful. Throughout 2013 PHEN will celebrate its ten year anniversary with ACTIONS as we continue executing our initiatives, collectively known as the “Rally Against Prostate Cancer.”
I invite you to celebrate with us by joining our rally and continuing your support of PHEN to help shape a future for all men absent prostate cancer.

Yours truly,

Thomas A. Farrington


Today is the last Monday of January 2013

January 28, 2013

Today is the last Monday of January 2013! Time flies. Don’t let time pass you by before knowing what you can about #Prostate Cancer


Giving Thanks at Christmas

December 10, 2012
Thomas A. Farrington, PHEN President and Founder

Thomas A. Farrington, PHEN President and Founder

The Christmas Season is a joyous time for giving thanks for our many blessings. As I reflect over this year and my twelve years as a prostate cancer survivor there is so much that I am personally thankful for. The progress that PHEN has made is certainly high on my list.

PHEN will celebrate its ten year anniversary in 2013. When founding this organization, based strictly on my passion to lessen the impact of prostate cancer on the men most at risk for the disease, I had no business plan for longevity, only a hope and desire for PHEN to make a difference. Today, I find it a remarkable blessing that we have been on this journey for a decade – succeeding in our mission by touching the lives of many men and their families.

To all of the survivors, supporters, partners and friends who have been on this journey with us – We wish you a Merry Christmas and Happy Holiday Season!

Thank you,

Tom Farrington


Prostate Cancer Clinical Trials – A New Day for Patients

November 8, 2012

Today prostate cancer patients with advanced disease have three relative new treatments available that improve overall survival. Provenge, Zytiga and Xtandi have all been approved by the Food and Drug Administration (FDA) over the past two years. These treatments represent significant progress for patients who for years had only chemotherapy to rely upon following hormone therapy. But the good news does not stop here.
Thomas A. Farrington, at PHEN's 2012 Summit
There are an increasing number of clinical trials using these “FDA approved” treatments. Importantly, these clinical trials are not experimental and seeking to prove the effectiveness and safety for these treatments. Effectiveness and safety were determined for each as part of the FDA approval process. Instead many of these trials are studies to better understand the treatments’ level of effectiveness relative to parameters such as stages of disease, genetic factors, in combination with other treatments, etc.

In most instances men participating in these trials are able to receive treatment with these expensive drugs for no cost and no increased risk. Clinical trials using these new treatments represent a new day for prostate cancer patients, especially for those that cannot afford these treatments.

It is important for African American men, who are at a higher risk for needing treatment for advanced disease, to participate in these trials to help better understand how these treatments can impact on eliminating the prostate cancer epidemic that we now suffer. Also, in some cases these trials will remove the access barrier that some men face.

PHEN will continue to highlight and focus on important clinical trials to insure that the men most impacted by prostate cancer are knowledgeable and have the opportunity to participate in this exciting new day for patients.

Remember, knowledge is the best defense against prostate cancer.


A Transformative Year

October 9, 2012
Thomas A. Farrington, at PHEN's 2012 Summit

Thomas A. Farrington, at PHEN’s 2012 Summit

2012 will undoubtedly be noted as a transformative year for prostate cancer. The controversial U. S. Preventive Services Task Force’s (USPSTF) recommendation against PSA screening captured headlines in the United States and around the world; The FDA approved Enzalutamide, another exciting new treatment for advanced prostate cancer; Major advancements have been made towards developing new diagnostics to help distinguish between cancers that should be treated and those that may be monitored; The U. S. Senate passed a resolution recognizing the occurrence of prostate cancer among African Americans to be of epidemic proportions. These are just a few of the major developments taking place in 2012.

What role can these transformative events play towards eliminating the African American epidemic as cited by the Senate? This was the focus of PHEN’s Eight Annual African American Prostate Cancer Disparity Summit hosted in Washington, DC, on September 20th and 21st. I have continually outlined my position against the USPSTF’s action which I consider a major impediment to progress. We addressed this issue at our summit and we will continue to do so aggressively.

New diagnostics was a bright spot at the summit with three outstanding presentations made in this area. Just two days prior to the summit Genomic Health made a major announcement regarding its evolving diagnostic test. Genomic’s senior director, Dr. Jeffrey Lawrence’s presentation at the summit will be featured during PHEN’s monthly webcast on October 10th. In addition, all three of the presentations will become available online via PHEN TV in the very near future.

As we march towards the end of 2012 I am truly excited for a brighter overall future for prostate cancer patients. PHEN’s primary mission is to ascertain that this future includes lifting the devastating epidemic from the African American population as recognized by the United States Senate. I am pleased that our “eight annual summit” was another important beacon helping to guide us towards realizing our mission. We will share the summit with our national audience over the coming weeks and months via our monthly webcasts and PHEN TV.


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