An estimated 160,000 men are diagnosed with prostate cancer annually in the U.S.1 Once diagnosed, these patients are left with the perplexing decision of whether or not to undergo an operation. Imperfect evidence, professional biases, and quality of life trade-offs make such treatment decisions difficult.
Urologic surgeons face increasing challenges in counseling these patients. Recent declines in prostate cancer screening following the U.S. Preventive Services Task Force recommendation against routine PSA (prostate-specific antigen)-based screening for prostate cancer may be leading to an increase in the incidence of more clinically aggressive prostate cancer.2-4 Furthermore, minority patients have higher morbidity and disparate outcomes, making these choices even more challenging for them. In fact, minority men experience worse outcomes, as measured in terms of mortality as well as quality of life after prostate cancer treatment. We recently published data demonstrating that minority males have limited access to robotic surgery.5 African-American, Native American, and Alaska-Native men, in particular, are more likely to have more aggressive prostate cancer and worse survival rates.6 African-American men are more vulnerable to receiving low-quality medical care, particularly when receiving primary therapy for localized disease.7,8 Social determinants of health status, biased health care systems, and complexity of follow-up care for populations lacking social support may contribute to this overall problem.
Addressing the complexities
To address these challenges and complex choices, clinical practice guidelines encourage shared decision making to ensure that newly diagnosed patients are familiar with all of the available treatment options and their associated risks and benefits. Having this information available allows them to better weigh their treatment modalities against their personal preferences to inform the decision-making process.
Decision aids can facilitate shared decision making by enabling patients to better comprehend the available evidence, comparative trade-offs, and how their values fit into the decision-making process. Some decision aids for prostate cancer do not incorporate individualized risk and patient-specific disease severity, nor do they address health care-related quality of life and life expectancy. None of these decision aids have been tested in a manner that samples sufficient minority populations to infer their effects in these populations. Our conversations with prostate cancer survivors have convinced us that having decision support tools available at the point of care with urologists may be critical when providing care to minority populations.
A191402 trial design
The A191402 trial, Decision Aids for Prostate Cancer in Minority Men, is designed to improve treatment decisions for minority men diagnosed with localized prostate cancer. The study will enroll 168 men over a two-year time period and will include a culturally sensitive decision aid for use by clinicians during their consultations with newly diagnosed prostate cancer patients. This decision aid, called the Prostate Cancer Choice tool (see Figure 1), along with another out-of-visit tool developed by the Agency for Healthcare Research and Quality, Knowing Your Options, will be tested during the trial (see Figure 2).
Figure 1. Prostate cancer choice tool
Figure 2. Schema of study
The A191402 study will oversample African-American, Native American, and Alaska-Native men with half of the enrollment slots reserved for this population. We have identified strategic partner sites to help us achieve these demographic recruitment targets. The aim of the study is to test the impact of the two different decision aids, alone and in combination, on patient knowledge and one-year quality of life in comparison with usual care.
We will use a “cluster-randomized” design, which assigns institutions to different intervention arms. As a result, all patients and physicians at a given site will get the same interventions. We will use statistical methods to ensure that site-to-site differences are accounted for, while making certain that “contamination” across study arms is minimized.
Planning for this trial began in 2012. Since then, we have been privileged to establish collaborations with national leaders in prostate cancer survivorship as well as with many colleagues in the urologic oncology community through the National Cancer Institute’s Community Oncology Research Program. The trial opens this month. For more information, contact Simon P. Kim, MD, MPH at email@example.com, or Jon C. Tilburt, MD, MPH, at firstname.lastname@example.org.
- Siegel RL, Miller KD, Jemal A. Cancer statistics. CA Cancer J Clin. 2017;67(1):7-30.
- Jemal A, Fedewa SA, Ma J, et al. Prostate cancer incidence and PSA testing patterns in relation to USPSTF screening recommendations. JAMA. 2015;314(19):2054-2061.
- Hu JC, Nguyen P, Mao J, et al. Increase in prostate cancer distant metastases at diagnosis in the United States. JAMA Oncol. Research letter. December 29, 2016. Available at: jamanetwork.com/journals/jamaoncology/article-abstract/2594540. Accessed April 3, 2017.
- Moyer VA. Screening for prostate cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2012;157(2):120-134.
- Kim SP, Boorjian SA, Shah ND, et al. Disparities in access to hospitals with robotic surgery for patients with prostate cancer undergoing radical prostatectomy. J Urol. 2013;189(2):514-520.
- Taksler GB, Keating NL, Cutler DM. Explaining racial differences in prostate cancer mortality. Cancer. 2012;118(17):4280-4289.
- Hayn MH, Orom H, Shavers VL, et al. Racial/ethnic differences in receipt of pelvic lymph node dissection among men with localized/regional prostate cancer. Cancer. 2011;117(20):4651-4658.
- Underwood W III, Jackson J, Wei JT, et al. Racial treatment trends in localized/regional prostate carcinoma: 1992–999. Cancer. 2005;103(3):538-545.