DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

The Prostate Cancer Clinical Trials Consortium: Clinical Research Site Application

Principal Investigator: HEATH, ELISABETH I
Institution Receiving Award: WAYNE STATE UNIVERSITY
Program: PCRP
Proposal Number: PC161031
Award Number: W81XWH-17-2-0022
Funding Mechanism: Clinical Consortium Research Site Award
Partnering Awards:
Award Amount: $1,232,000.00


TECHNICAL ABSTRACT

Expertise: As a current member of the Department of Defense Prostate Cancer Clinical Trials Consortium (PCCTC) (www.pcctc.org), the Wayne State University (WSU)/Karmanos Cancer Institute (KCI) Clinical Research Site has already contributed substantially to the development and approval of exciting and effective novel agents for treating prostate cancer. Over 50 physicians and researchers, most of whom are part of the Prostate Cancer Research Team or the Genitourinary Multidisciplinary Team, contribute to PCCTC trials. The PCCTC clinical trial portfolio represents over 26% of all industry-sponsored and 13% of National Institutes of Health-sponsored early phase prostate cancer trials in the United States. Since the Consortium’s inception in October 2005, the large number of submitted (235), approved (193), activated (185), and completed (142) trials was possible due to the combined recruitment by the PCCTC of over 5,456 patients to clinical trials; of these, more than 10% were from disproportionately affected populations. At our site, 41% of the prostate cancer patients enrolled annually in clinical trials were from disproportionately affected populations. We attribute our high enrollment rate to several factors, including dedicated, team-based clinicians and investigators as well as focused investigator-initiated research on improving clinical trial accrual among underserved populations. By increasing trial opportunities within an accessible healthcare system located in a predominantly African American community, namely, Detroit, we will improve trial access and overcome some of the other barriers to clinical trial enrollment for African Americans and other disproportionately affected populations.

Resources: WSU/KCI investigators have access to a variety of cutting-edge resources, including ample clinical and laboratory space; the WSU School of Medicine; the Karmanos Cancer Center; nine institutional cores, including the Clinical Trials Office, Biostatistics Core, Biobanking and Correlative Sciences Core, and Pharmacology Core; as well as many other programs. The members of the Prostate Cancer Research Team and the Genitourinary Multidisciplinary Team are engaged in the research that has contributed to the overall success of clinical trial accrual. Our investigators also enjoy the support of WSU and KCI leadership, who enable access to necessary physical and financial infrastructure requirements.

Prostate Cancer Population: Located in Detroit, KCI serves primarily the surrounding four counties, which had a population of 4.1 million in 2009-2010. The City of Detroit has seen a steady population decline over the past two decades and has suffered greatly from the setbacks in the automotive industry. The population of Detroit is predominantly African American (82.7%), and 33.8% of Detroit residents live below the poverty level, 10.3% are unemployed, 47% of adults are functionally illiterate, and 35% did not graduate from high school. Karmanos is the primary provider of cancer care for socioeconomically disadvantaged persons in Detroit, with approximately 21%-23% having no Medicare or private insurance coverage. Among prostate cancer patients, 50% are African American, and the average age of patients in PCCTC clinical trials was 71 years (range: 55-85) and in biomarker studies was 61 years (range: 44-80). We continue to strive to break barriers of accrual, despite the high illiteracy rate, poverty, and bankruptcy of some of our patients.

Study Design: The types of clinical trials that we intend to propose to the Consortium have emerged from our focus on developing effective treatments and addressing mechanisms of resistance in men with high-risk or metastatic prostate cancer. For example, we have expertise in clinical trials that (1) evaluate novel agents as a single or combination therapy or modality and (2) evaluate the impact of therapy in African American men by assessing biologic factors that influence their response to therapy, such as inflammation, genetic makeup, and immune responsiveness. In this funding period, we will design prospective studies of racial differences in disease type, physiologic factors, and response to treatment, aiming at more precise personalized medicine.

Clinical Impact: Being a current member of the PCCTC has already had a major impact on prostate cancer clinical management by expanding our clinical trials portfolio, which offers significantly diverse agents for treatment considerations and by developing clinical trials that focus on the effect of treatment on the biology of men with high-risk or more aggressive disease.