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• W2516404890 abstract "Despite the impressive advances in the diagnosis and treatment of prostate cancer achieved over the past decade, several basic questions remain unanswered. The utility of prostate-specific antigen (PSA) as a screening tool and the use of systemic chemotherapy in patients with advanced disease are two such topics. As with all dilemmas in medicine, clinical data obtained from high-volume studies serve to refine our understanding, prompting the formulation of clinical pathways, whose subsequent execution by individual practitioners should result in better patient care. However, this study-to-clinic transformation cannot be complete in the absence of one important denominator: the studies' generalizability. The majority of clinical studies in prostate cancer have been characterized by exceedingly low participation rates of African-American men. As a recent analysis of us shows, African-American men, despite being more prone to develop and to SUCCUMB to the complications of prostate cancer, have been disproportionately represented in clinical trials [1.OOren, DFBeach. Representation of African-American patients in clinical studies of prostate cancer. Journal of Clinical Oncology, 2016; 34: e18057.Google Scholar]. The implications are broad, since proper representation of the population is important for any scientifically sound clinical investigation. When white patients are enrolled in numbers that over account for their epidemiological fraction in society, the generalizability of any conclusion to the African-American population may be inadequate, potentially leading to biased clinical guidelines. A case in point is the controversial PSA-based screening. Significant variability is inherent in guidelines issued by various professional organizations. The United States Preventive Services Task Force (USPSTF) currently recommends against PSA-based screening for prostate cancer in all age groups [2.US Preventive Services Task Force. Final Evidence Summary: Prostate Cancer Screening. http://www.uspreventiveservicestaskforce.org/Page/Document/final-evidence-summary43/prostate-cancer-screening (22 September 2016, date last accessed).Google Scholar]. The American Urological Association, in contrast, endorses screening in all asymptomatic men aged 40 and older (as an adjunct to digital rectal examination) or those with an estimated life expectancy >10 years who wish to be screened [3.American Urological Association. Guidelines for the Management of Clinically Localised Prostate Cancer. https://www.auanet.org/education/guidelines/prostate-cancer.cfm (22 September 2016, date last accessed).Google Scholar]. The American Cancer Society and the American College of Preventive Medicine support individualized decision-making [4.American Cancer Society Guideline for the Early Detection of Prostate Cancer: Update 2010. http://onlinelibrary.wiley.com/doi/10.3322/caac.20066/full (22 September 2016, date last accessed).Google Scholar, 5.Screening for Prostate Cancer in US Men ACPM Position Statement on Preventive Practice. https://c.ymcdn.com/sites/www.acpm.org/resource/resmgr/andrea/prostate2008positionstatemen.pdf (22 September 2016, date last accessed).Google Scholar]. These and other groups continue to evaluate the science, attempting to decipher whether early detection of prostate cancer using serum markers truly results in any survival benefit. Yet, a key obstacle to obtaining a data-driven consensus is the ethnic cosmos of available studies. As shown in Table 1, the landmark randomized clinical trials that examined the impact of screening had an exceptionally low representation of African-American men [6.Andriole G.L. Crawford E.D. Grubb III, R.L. et al.Mortality results from a randomized prostate-cancer screening trial.N Engl J Med. 2009; 360: 1310-1319Crossref PubMed Scopus (2376) Google Scholar, 7.Labrie F. Candas B. Cusan L. et al.Screening decreases prostate cancer mortality: 11-year follow-up of the 1988 Quebec prospective randomized controlled trial.Prostate. 2004; 59: 311-318Crossref PubMed Scopus (170) Google Scholar, 8.Sandblom G. Varenhorst E. Rosell J. Randomised prostate cancer screening trial: 20 year follow-up.BMJ. 2011; 342: d1539Crossref PubMed Scopus (122) Google Scholar, 9.Kjellman A. Akre O. Norming U. 15-Year followup of a population based prostate cancer screening study.J Urol. 2009; 181: 1615-1621Crossref PubMed Scopus (75) Google Scholar, 10.Schröder F.H. Hugosson J. Roobol M.J. et al.Screening and prostate-cancer mortality in a randomized European study.N Engl J Med. 2009; 360: 1320-1328Crossref PubMed Scopus (3260) Google Scholar]. Of the five trials featured in the table, only one reported having African-American participants. This study—the large, population-based Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) study—had merely 4% non-Hispanic black men among its participants [6.Andriole G.L. Crawford E.D. Grubb III, R.L. et al.Mortality results from a randomized prostate-cancer screening trial.N Engl J Med. 2009; 360: 1310-1319Crossref PubMed Scopus (2376) Google Scholar]. The European Randomised study of Screening for Prostate Cancer (ERSCP), similar to other studies shown in the table, did not include data about the racial demographic characteristics of its participants [10.Schröder F.H. Hugosson J. Roobol M.J. et al.Screening and prostate-cancer mortality in a randomized European study.N Engl J Med. 2009; 360: 1320-1328Crossref PubMed Scopus (3260) Google Scholar].Table 1Landmark studies focusing on prostate-specific antigen-based screening for prostate cancerStudyAfrican-Americans (% of total participants)Mortality reduction with screeningAndriole et al. [6.Andriole G.L. Crawford E.D. Grubb III, R.L. et al.Mortality results from a randomized prostate-cancer screening trial.N Engl J Med. 2009; 360: 1310-1319Crossref PubMed Scopus (2376) Google Scholar]4.4No difference (at 7–10 years)Labrie et al. [7.Labrie F. Candas B. Cusan L. et al.Screening decreases prostate cancer mortality: 11-year follow-up of the 1988 Quebec prospective randomized controlled trial.Prostate. 2004; 59: 311-318Crossref PubMed Scopus (170) Google Scholar]None62%Sandblom et al. [8.Sandblom G. Varenhorst E. Rosell J. Randomised prostate cancer screening trial: 20 year follow-up.BMJ. 2011; 342: d1539Crossref PubMed Scopus (122) Google Scholar]NoneNo difference (at 20 years)Kjellman et al. [9.Kjellman A. Akre O. Norming U. 15-Year followup of a population based prostate cancer screening study.J Urol. 2009; 181: 1615-1621Crossref PubMed Scopus (75) Google Scholar]NoneNo difference (at 15 years)Schröder et al. [10.Schröder F.H. Hugosson J. Roobol M.J. et al.Screening and prostate-cancer mortality in a randomized European study.N Engl J Med. 2009; 360: 1320-1328Crossref PubMed Scopus (3260) Google Scholar]None20% Open table in a new tab Several questions reflexively come to mind: Why did so many pivotal studies fail to report patients' racial demographics? Why did the few that reported had such a minimal fraction of black men? In addition, why was race left out of the statistics, with some studies adjusting mortality rates for age and baseline co-morbidities, but not for race (a potent risk factor for prostate cancer)? When trying to answer those questions, one must remember that many of the studies were international based, with few if any active recruitment centres in the USA. The number of black participants in those studies might have been zero (or close to it) which made the reporting of ethnic information virtually obsolete. Most of the other studies, even those based in America, had such a low participation rate of minority populations, which could have compounded statistical analysis of any relevance to African-Americans. To understand why African-Americans are under-represented in clinical studies—including in the arena of cancer—requires comprehension of history (i.e. racial experimentation resulting in mistrust) but also appreciation of economic factors and communication issues, which is beyond the scope of this article. Nevertheless, it is worthwhile mentioning that under-representation of racial minorities in key clinical trials is almost a global norm. In a comprehensive analysis of 17 pivotal clinical trials submitted to the Food and Drug Administration for review between the years 1993 and 2013, minority enrolment was very low in all countries (7.1% in the USA; <5% in Europe) [11.Wissing M.D. Kluetz P.G. Ning Y.M. et al.Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993–2013.Cancer. 2014; 120: 3025-3032Crossref PubMed Scopus (30) Google Scholar]. Enrolment did not exceed 15% in any Canadian or Australian study [11.Wissing M.D. Kluetz P.G. Ning Y.M. et al.Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993–2013.Cancer. 2014; 120: 3025-3032Crossref PubMed Scopus (30) Google Scholar]. Information about Hispanic/Latino origin was not collected as a distinct category in many studies, while other trials excluded Hispanics from the analysis because of their small numbers. Clearly, under-inclusion of black patients in the USA is only a singular symptom of a broader disease that will have to be addressed. It is crucial that we learn from the failures of the past to ensure that future investigations better capture the clinical problems we aim to solve. African-Americans' biological vulnerability to prostate cancer is well-established: incidence is higher, stage at diagnosis is higher, mortality is higher [12.Williams H. Powell I.J. Epidemiology, pathology, and genetics of prostate cancer among African Americans compared with other ethnicities.Methods Mol Biol. 2009; 472: 439-453Crossref PubMed Scopus (58) Google Scholar]. Despite that, we still do not have enough studies to inform us about the balance of benefits versus harms associated with PSA-based screening in the black population. One commendable scientific endeavour is the Prostate Cancer Intervention Versus Observation Trial (PIVOT) in which 30% of the enrolees were black [13.Wilt T.J. Brawer M.K. Jones K.M. et al.Radical prostatectomy versus observation for localized prostate cancer.N Engl J Med. 2012; 367: 203-213Crossref PubMed Scopus (1460) Google Scholar]. The study compared radical prostatectomy and observation for patients with localized prostate cancer detected in the PSA screening era. After 12 years of follow-up, there was no difference in disease-specific or all-cause mortality between the two groups. The PIVOT trial was revolutionary not only because it transformed the way we manage localized prostate cancer, but also due to its racially diverse mix of participants. Almost for the first time in a major active investigation in prostate cancer, the black minority population enjoyed ideal representation. Would outcomes of other leading studies be different with adequate inclusion of black participants? The ERSPC trial concluded that ‘the benefit from screening was restricted to the core age group of subjects who were between the ages of 55 and 69 at the time of randomization.’ Could it be that strong evidence for PSA screening was demonstrated in younger patients (and not older) because in those age groups a greater proportion of African-Americans were included, allowing closer reflection of the true epidemiological distribution of the disease? Would any screening-related benefit be detected with a greater fraction of African-American participants among the older age group? We do not really know. In our research, we investigated the extent of under-inclusion of African-American men in clinical studies of prostate cancer. Using the clinicaltrials.gov electronic registry, we collected information about all published interventional clinical studies in prostate cancer done in American men. We showed that of 42 phase 3/4 clinical studies, 54.7% (23/42) had no ethnic stratification [1.OOren, DFBeach. Representation of African-American patients in clinical studies of prostate cancer. Journal of Clinical Oncology, 2016; 34: e18057.Google Scholar]. In the few trials that did report demographic information, there were 5116 (9.8%) African-American and 41 103 (79.4%) white participants (out of a total of 51 766 individuals). Astonishingly, ∼92% of the total number of black participants came from four of the studies. These findings are intriguing. They exemplify a paradoxical phenomenon whereby individuals with a potent risk factor (African-American race) for a disease are less likely to be included in practice-changing investigations. An analogy outside the oncology arena would be a major heart failure study that excludes patients with underlying hypertension, or an atrial fibrillation trial that lacks elderly participants. Obviously, these are unacceptable scenarios in the realm of cardiovascular research. In the same vein, African-American patients must assume an integral part in prostate cancer research. If we are ever to effectively tailor our recommendations for this important population, we need to start recruiting them into high-quality trials, and effectively so. What can be done to increase the enrolment rate of African-American participants into clinical trials? Reaching out to black individuals in their communities could be the first step. Well-informed African-American advocates who would share stories about their participation in clinical trials may well be a way to achieve that. We can also consider offering more generous financial reimbursements to under-represented individuals. Another strategy is to provide an economical incentive to investigators who include African-Americans in a manner truly reflective of their true prevalence/incidence. Medical journals should factor in population representation aspects when assessing a study's merit, on top of the overall results. The patient navigation strategy is a promising new tool that may ameliorate part of the racial disparity in study enrolment. One recent study showed that the provision of basic education about clinical trials with tailored support to those who enrolled, via trained laypersons (‘patient navigators’), resulted in greater retention rates of African-American individuals in clinical trials (16% versus 6%) [14.Fouad M.N. Acemgil A. Bae S. et al.Patient navigation as a model to increase participation of African-Americans in cancer clinical trials.J Oncol Pract. 2016; 12: 556-563Crossref PubMed Scopus (64) Google Scholar]. Another encouraging initiative, the ‘clinical trials shared resource’, represents a stepwise process of early identification of black patients with particular disease, collection of information about their eligibility and barriers for participation, followed by development of strategies to address those obstacles. Intervention of that nature led to 78% participation rate by eligible African-American patients, up from 58% in the control arm [15.Wujcik D. Wolff S. Recruitment of African Americans to National Oncology Clinical Trials through a Clinical Trial Shared Resource.J Health Care Poor Underserved. 2010; 21: 38-50Crossref PubMed Google Scholar]. These proactive measures are costly and resource-intensive, but they are a crucial recipe needed to help increase the rate of participation of black patients in clinical studies. Billions of dollars are invested each year in pursuit of better prevention and treatment of patients with prostate cancer. If we truly want to translate the wisdom of those studies into fruitful outcomes, however, we must be fair to ourselves and to those we serve. Otherwise, we will be all left behind. None declared." @default.
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• W2516404890 title "On the generalizability of prostate cancer studies: why race matters" @default.
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