DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Prostate Cancer Clinical Trials Consortium Clinical Research Site: University of Washington

Principal Investigator: HIGANO, CELESTIA S
Institution Receiving Award: WASHINGTON, UNIVERSITY OF
Program: PCRP
Proposal Number: PC161019
Award Number: W81XWH-17-2-0043
Funding Mechanism: Clinical Consortium Research Site Award
Partnering Awards:
Award Amount: $1,000,000.00


TECHNICAL ABSTRACT

Expertise: The University of Washington (UWash) prostate cancer research program is committed to studying all stages of prostate cancer. Because of the affiliation with the Fred Hutchinson Cancer Research Center (Fred Hutch), the research program benefits from a multidisciplinary group of nationally renowned clinical researchers, basic scientists, and epidemiologists who study the continuum of disease from prevention to metastatic castration-resistant prostate cancer. The objectives of the UWash research site align with the Overarching Challenges of the Fiscal Year 2016 Prostate Cancer Research Program (PCRP). Since 2007, the UWash has been awarded three full rounds of Department of Defense (DoD) funding to serve as a clinical research site for the Prostate Cancer Clinical Trials Consortium (PCCTC). As a PCCTC research site, UWash has exceeded DoD-defined targets by proposing 19 clinical trials, opening more than 50 clinical trials overall, and accruing more than 450 patients across the spectrum of prostate cancer. Also, the Principal Investigator of the UWash site, Celestia Higano, MD, has led the PCCTC publications committee, and since 2013, has served on the PCCTC Scientific Oversight Committee at the invitation of the Director of the Coordinating Center. This history of participation, with the support of our research team and our institution, lays the foundation to pursue a fourth round of funding to continue as a PCCTC research site.

Resources: Since 1976, Fred Hutch and UWash have conducted thousands of clinical trials and established an infrastructure for adhering to National Cancer Institute (NCI), Food and Drug Administration, and other regulatory guidelines. Its infrastructure includes Research Trials Office, which facilitates research trials and coordinates processes for protocol scientific review and monitoring within the UWash/Fred Hutch Cancer Consortium via a scientific review committee, a protocol and data monitoring committee, data and safety monitoring boards, regulatory affairs, a clinical trials support office, and a biostatistics and clinical informatics shared resource, which includes Caisis, the prostate cancer clinical data repository that is used by the PCCTC. The Investigational Drug Service through the UWash Medical Center provides accountability, handling, storage, and control of investigational drugs and ensures compliance with both federal regulations and sponsor standards. Because UWash has served as a PCCTC site for almost a decade, its processes are integrated into the broader institutional infrastructure.

Prostate Cancer Population: In 2015, more than 2800 new patients with prostate cancer were evaluated at the UWash, ranging in age from 42 to 93. Almost 300 men were treated for localized disease, and medical oncology saw more than 400 new patient visits and over 3100 return visits. Patients come from a large geographic area: 90% are from Washington State, 9% from other states, and 1% from foreign countries. Since our last submission, the Fred Hutch created a new Health Disparities Research Center, which holds three NCI grants on health disparities research, training, and education, and will aid in the UWash research site accrual of disproportionately affected populations to PCCTC trials. A new affiliation with MultiCare Health System located in the South Puget Sound area will also help address this area.

Study Design: The UWash research site will propose and participate in studies that reflect the PCRP Focus Areas, particularly therapy with new agents including immunotherapy and mechanisms of resistance and response. We plan to accrue at least 25 patients per year to PCCTC clinical trials, actively recruiting men from disproportionately affected populations consistent with the demographics of Washington State. We will propose at least two trials per year and participate in at least eight trials initiated by other sites over the 4-year funding period. For all studies, we will continue to comply with all mandates from the PCCTC Coordinating Center (timely, quality submission of data, teleconference participation, report completion, meeting attendance). Dr. Higano will continue as chair of the publications committee and as a member of the Scientific Oversight Committee.

Clinical Impact: To date, the UWash participation in the PCCTC has yielded more than 30 publications and more than 75 presentations at professional meetings. UWash participated in five PCCTC trials that have progressed to six Phase III trials, two of which reported a survival benefit (PREVAIL, AFFIRM). The goal of the PCCTC is to rapidly advance treatment options for men with all stages of prostate cancer. Through the PCCTC, our work will enhance our understanding of response to systemic therapies, hone our ability to personalize therapy based on translational and clinical data, and improve our understanding of tumor biology, which in turn will inform PCCTC clinical trials that may steer the treatment of men with prostate cancer in the foreseeable future.