Biomarker Testing Needed Before African American Patients Choose Active Surveillance

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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

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