DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Clinical Consortium Research Site Award

Principal Investigator: BEER, TOMASZ M
Institution Receiving Award: OREGON HEALTH AND SCIENCE UNIVERSITY
Program: PCRP
Proposal Number: PC161018
Award Number: W81XWH-17-2-0018
Funding Mechanism: Clinical Consortium Research Site Award
Partnering Awards:
Award Amount: $1,228,646.00


TECHNICAL ABSTRACT

Expertise: Led by Tomasz M. Beer, an internationally recognized leader in prostate cancer research, the multi-departmental, multi-disciplinary Prostate Cancer Research Program of the Oregon Health and Science University (OHSU) Knight Cancer Institute has served as a member of the Prostate Cancer Clinical Trials Consortium (PCCTC) since the Consortium’s inception. A core group of seasoned clinician investigators in medical, surgical, and radiation oncology works in synergy with scientists conducting peer review funded prostate cancer research in cancer biology, and translational, clinical, and population science. Through understanding the biologic basis of prostate carcinogenesis, our group creates and evaluates novel targeted approaches for the prevention and treatment of prostate cancer with the goal of reducing morbidity and mortality associated with this disease. The group has substantial experience in prostate cancer clinical trials, from Phase I to Phase III, and has demonstrated this expertise with the ground-breaking advance that established enzalutamide as a global standard of care in advanced prostate cancer. By virtue of being involved in the Pacific Northwest SPORE (Specialized Program of Research Excellence) and the West Coast Dream Team, the group also has deep translational capabilities that enable innovative biomarker discovery and validation studies. We have extensive experience with obtaining biopsy specimens from metastatic lesions. We also have significant molecular analysis capabilities that support the Dream Team as well as the PCCTC. We have unique expertise in multiscale imaging, from angstrom-level imaging of intracellular processes to human scale anatomic, functional, and molecular imaging. Finally, we have a world-class clinical research infrastructure with a large, expert, and experienced team of investigators and personnel whose capabilities are best illustrated by our contributions to the PCCTC since its founding in 2005.

Resources: The prostate cancer team is supported by a dedicated staff of 11 that is led by Kristine Eilers, our Institutional Clinical Research Coordinator. The team benefits from the comprehensive resources of the Knight Cancer Institute, a National Cancer Institute (NCI) Designated Cancer Center, which provides full access to a broad range of shared resources, dedicated finance and contracts staff, and an environment that brings together more than 140 investigators across a range of disciplines. The program has full access to the Knight Diagnostic Laboratory, a CAP/CLIA certified molecular diagnostics laboratory, the Oregon Clinical and Translational Research Institute, which supports research space dedicated to complex Phase I studies, the Advanced Imaging Research Center, which provides world-class clinical research imaging, and the Center of Spatial Systems Biology, which provides unrivaled microscopy and computational biology resources.

Prostate Cancer Population: As the only NCI Designated Cancer Center in Oregon, we serve the prostate cancer population of the entire state. On average, 2,501 Oregonians are diagnosed and 413 die from prostate cancer each year. Our program is tightly integrated with the Portland Veterans Affairs Medical Center, where two of our faculty, including the Principal Investigator, care for all of the region’s Veterans with advanced prostate cancer. We serve men with prostate cancer at all stages of the disease including localized, biochemical relapse, castrate-sensitive, and castrate-resistant; it is our aim to have a trial for every patient who seeks it. One area of particular focus is patients whose cancer has progressed despite second-generation anti-androgens.

Study Design: With our PCCTC partners, we will conduct Phase I and II clinical trials of new agents and combinations based on strong preliminary evidence of promise. We will study agents that are aimed at targets relevant to prostate cancer development, growth, and spread. We will develop well-designed clinical trials that clearly inform the go/no go decisions that must follow. We will emphasize study designs that, in addition to answering fundamental clinical questions, delve deeper and teach us about the reasons for clinical outcomes through biologic investigations. Ultimately, we envision a future of personalized cancer therapy, where treatment regimen design will be refined to the level of the individual patient and driven by the molecular characterization of each tumor. We will continue to engage a broad range of targets, but we will emphasize studies that build on our contributions in androgen receptor targeting and immunotherapy.

Clinical Impact: With our leadership and participation, four agents that began their Phase I and/or II evaluation in the PCCTC advanced to Phase III trials and two have been approved for advanced prostate cancer, resulting in longer survival of men with advanced prostate cancer across the globe. Through Consortium studies, we intend to clarify mechanisms of resistance and develop combination strategies that will further substantially improve patient outcomes.