SAN DIEGO—Enrollment of black men into randomized clinical trials (RCTs) of prostate cancer treatments is low and has not improved substantially over time, according to findings presented at the American Urological Association annual meeting.
Joseph Pugh, MD, of the University of Florida College of Medicine in Gainesville, and colleagues reviewed enrollments in 288 RCTs published from 2002 to 2011, of which about 47% were conducted with patients who had localized PCa and 30.2% were conducted with patients who had metastatic disease. Of the 288 trials, only 63 (21.9%) reported enrollment of black men, with a median of 12.
Over the 10-year study period, the percentage of studies that included black men ranged from a low of 10% in 2005 to a high of 16% in 2002, but the Dr. Pugh’s team observed no significant trend in changes over time. The proportion of studies involving black men was highest with studies conducted in the U.S. compared with other countries (43.9% vs. 7.8%). The researchers identified no study that enrolled black men exclusively or prospectively planned to stratify analyses based on ethnic background.
“Considering the high disease burden of prostate cancer in black men, increased effort to improve their participation in RCTs is essential,” the authors concluded.