Successful Recruitment of Black Men to Prostate Cancer Clinical Trials—A Lesson in Achievement

Abstract

Over the past 5 years, multiple phase 3 clinical trials have established that addition of docetaxel, abiraterone acetate, apalutamide, or enzalutamide to androgen deprivation therapy (ADT) significantly improve survival for men with metastatic hormone-sensitive prostate cancer (mHSPC). 1 Vaishampayan and colleagues 2 report the results of a randomized (1:1) trial comparing enzalutamide plus ADT with bicalutamide plus ADT in 71 men with mHSPC. The primary end point of the trial was 7-month prostate-specific antigen (PSA) remission rate (SMPR), defined as a PSA nadir of less than 4 ng/mL after 7 months of systemic therapy. 2 The primary end point favored enzalutamide plus ADT compared with bicalutamide plus ADT, with 94% vs 65% of patients achieving SMPR. Moreover, treatment with enzalutamide also improved time to PSA progression and overall survival (OS). Their overall findings are consistent with results from the 2 recently reported phase 3 clinical trials of enzalutamide in this setting (ie, ENZAMET and ARCHES). 1 What stands out and makes this report 2 so remarkable is that it is a prospective randomized clinical trial of men with mHSPC with a novel hormonal therapy where subset analysis of outcomes in Black men was prespecified. Historically, Black patients are underrepresented in clinical trials; this was the case in the ARCHES trial, with 1.4% Black enrollment. 1 It was likely the case in the ENZAMET trial, 1 but race was not included in the baseline characteristics. In contrast, in the trial by Vaishampayan and colleagues, 2 41% of patients were Black.

Racial disparities in Black men with prostate cancer: A literature review

“…15 To increase recruitment of Black men into clinical trials, the following approaches have been proposed: educate clinicians and clinical trial recruiters regarding racial disparities in enrollment, increase clinician diversity, provide financial assistance to patients, reduce barriers to travel by increasing placement of cancer centers in areas with high minority populations, and engage with participants at commonly used community facilities, such as places of worship. 75,79 In addition, the inclusion of equal-access health care systems and availability for remote visits in future study designs could also increase Black participation. 5 The Prostate Outreach Project provided free PSA screening Cancer November 1, 2022 and PCa education events, which led to the recruitment of 4420 men between 2003 and 2009, 62.8% of whom were Black.…”

“…US Food and Drug Administration guidance for industry‐funded and government‐funded clinical study designs recommends enrolling participants who reflect the diversity of the clinically relevant target population 15 . To increase recruitment of Black men into clinical trials, the following approaches have been proposed: educate clinicians and clinical trial recruiters regarding racial disparities in enrollment, increase clinician diversity, provide financial assistance to patients, reduce barriers to travel by increasing placement of cancer centers in areas with high minority populations, and engage with participants at commonly used community facilities, such as places of worship 75,79 . In addition, the inclusion of equal‐access health care systems and availability for remote visits in future study designs could also increase Black participation 5 .…”