iCAN PREVENT: MD Anderson International Cancer Prevention Clinical Trials Consortium

Cancer is second cause of death in the United States. Cancer prevention strategies represent the most promising means by which to reduce cancer-related deaths and cancer incidence. Feasibility of vaccines and cancer prevention drugs has been demonstrated in clinical trials targeting the prevention of cancer (recently renamed as ‘Cancer Interception'). Unfortunately, side effects associated with the use of these agents has limited their use. Therefore, there is an urgent need for more effective and less toxic cancer prevention interventions that healthy individuals would deem as both beneficial and tolerable. Our overarching goal is to continue developing the next wave of cancer interception agents by engaging our expert team of researchers to: 1. identify and develop novel effective and tolerable cancer interception strategies; 2. test the most promising of those strategies in early-phase cancer prevention clinical trials; and 3. translate these therapies to the clinic for individuals at high-risk of cancer. To this end, the MD Anderson “iCAN PREVENT” Consortium has renewed its commitment to cancer interception by bringing additional world leaders in cancer prevention, novel concepts for future clinical trials, updating our cores with state-of-the-art technologies (spatial transcriptomics, single-cell genomics), incorporating novel approaches to recruit and retain participants and incorporating a council of patient advocates combined with our pathology, systems biology, and statistics experts, to collaborate in the development of novel early-phase cancer interception clinical trials. With over 30 Phase I and II prevention trials conducted through our previous MD Anderson clinical trial consortia, our team brings knowledge and experience in the development and conduction of clinical trials while we incorporate novel ideas from junior investigators and new trial sites. To continue supporting these clinical trials, we focus on two aims: 1. testing the safety and efficacy of cancer prevention drugs, vaccines, and immune modulating interventions in individuals at high-risk for cancer development in >5 early-phase prevention trials; and 2. implementing the most novel methods to enhance recruitment and retention of participants to our trials. Included in this application are two sample trials: 1. a Phase II study testing low-dose enzalutamide for prostate cancer prevention in men with low-risk prostate cancer who are under active surveillance; and 2. a Phase II study comparing the efficacy of aerobic exercise, naproxen or the combination of both to modulate the immune system for cancer prevention in Lynch syndrome carriers. In addition, we present several potential concepts to be developed by our consortium. The results of our previous preventive studies have demonstrated that we are leaders developing new cancer interception strategies, which would provide the foundation to advance these interventions to Phase III with the ultimate goal of FDA-approval.