Are comorbid obesity and type 2 diabetes priorities in federally-funded prostate cancer clinical trials
Abstract
BACKGROUND: Obesity, diagnosed in 37.5% of African American (AA) men, is a risk factor for prostate cancer (PCa) recurrence, progression, and increased mortality. Obesity is associated with aggressive PCa only in AA men and not White American (WA) men. The overall health of PCa patients is also more likely to be adversely affected by comorbid type 2 diabetes (T2D), leading to reduced odds of survival. This evidence suggests that preventing and controlling comorbid obesity and T2D in AA men diagnosed with PCa should be a research funding priority.
AIM: To determine if interventions conducted in federally-funded PCa clinical trials controlled for T2D and obesity.
METHODS: Completed interventional PCa clinical trials conducted in the U.S., funded by the NIH or other federal agency, which included males aged 18-64 years, and reported study protocols were included in the study. We examined the intervention modalities used in the trials to determine if any attempted to control for obesity and T2D.
RESULTS: 58 trials met the initial inclusion criteria. Of these, 12 were excluded from the analysis as they did not report AA men. Of the remaining 46 trials, 42 (91.3%) used pharmaceutical drug therapies or clinical procedures, and 2 (4.35%) were for weight loss and diet. A total 5192 men participated in the 42 drug intervention trials. Of these, 755 (14.5%) were AA men. None of the drugs used or clinical procedures affected obesity and T2D.
CONCLUSION: Scientific evidence points to adverse effects of obesity and T2D that are unique to AA men diagnosed with PCa. The overwhelming majority (95.65%) of the federally funded PCa clinical trials that included AA men did not use methods to control for obesity and T2D. This gap in therapeutic optimization to control these comorbid conditions indicates a critical area in need of federal funding priority.
Keywords
Prostate cancer, clinical trials, equity, inequities, oncology
Are comorbid obesity and type 2 diabetes priorities in federally-funded prostate cancer clinical trials
BACKGROUND: Obesity, diagnosed in 37.5% of African American (AA) men, is a risk factor for prostate cancer (PCa) recurrence, progression, and increased mortality. Obesity is associated with aggressive PCa only in AA men and not White American (WA) men. The overall health of PCa patients is also more likely to be adversely affected by comorbid type 2 diabetes (T2D), leading to reduced odds of survival. This evidence suggests that preventing and controlling comorbid obesity and T2D in AA men diagnosed with PCa should be a research funding priority.
AIM: To determine if interventions conducted in federally-funded PCa clinical trials controlled for T2D and obesity.
METHODS: Completed interventional PCa clinical trials conducted in the U.S., funded by the NIH or other federal agency, which included males aged 18-64 years, and reported study protocols were included in the study. We examined the intervention modalities used in the trials to determine if any attempted to control for obesity and T2D.
RESULTS: 58 trials met the initial inclusion criteria. Of these, 12 were excluded from the analysis as they did not report AA men. Of the remaining 46 trials, 42 (91.3%) used pharmaceutical drug therapies or clinical procedures, and 2 (4.35%) were for weight loss and diet. A total 5192 men participated in the 42 drug intervention trials. Of these, 755 (14.5%) were AA men. None of the drugs used or clinical procedures affected obesity and T2D.
CONCLUSION: Scientific evidence points to adverse effects of obesity and T2D that are unique to AA men diagnosed with PCa. The overwhelming majority (95.65%) of the federally funded PCa clinical trials that included AA men did not use methods to control for obesity and T2D. This gap in therapeutic optimization to control these comorbid conditions indicates a critical area in need of federal funding priority.
