MULTI-CENTER NATIONAL DATABASE PROGRAM
Understanding the Fight Against Prostate Cancer
Currently, little is known about the causes of prostate cancer development. Only advanced age, family history, and race/ethnicity have been established as risk factors for cancer development. There is continued debate over the value of annual PSA screening in asymptomatic men or treatment in men with low risk disease. Such debate can be confusing for patients -- and not all experts agree on these important topics.
Leveraging Programmatic Strengths to Improve Patient Outcomes
The Center for Prostate Disease Research (CPDR) Multi-center National Database Program seeks to longitudinally collect comprehensive demographic, clinical, treatment and quality of life outcomes data to learn more about prostate disease, particularly prostate cancer, in an effort to better prevent, diagnose and treat patients. The database is a highly valuable programmatic resource that enables CPDR researchers to examine patients diagnosed in an equal access health care system, who are characterized by racial/ethnic heterogeneity. Patient data are linked to bio-specimens including urine, serum, and tissue providing opportunity to examine important translational research questions, including biomarkers of disease detection and progression.
- Obtain informed consent to enroll men with prostatic diseases for longitudinal follow-up
- To capture comprehensive clinico-pathologic, demographic, and longitudinal follow-up data including treatment outcomes, as part of routine data collection activities
- To assess at regular intervals the health-related quality-of-life of patients, along the continuum of prostate disease care
- To serve as a critical link in support of basic science and clinical science research, providing unprecedented opportunities for translational research
- To provide a resource for training and education of medical residents and students
- To provide a national resource for prostate disease researchers, supporting breakthroughs in studies on prostate disease prevention, diagnosis, and treatment
Unique attributes of the database include a study population comprised primarily of military health care beneficiaries with comparable access to health care and uniformity in PSA screening and treatment guidelines; an over-representation of African American men, allowing for in-depth examination of the impact of race/ethnicity on prostate cancer outcomes; abundant clinical data necessary to calculate risk factors for disease development and progression, including PSA kinetics (e.g., doubling time, velocity) and obesity; (robust, long term data on health-related quality-of-life outcomes during the period of cancer survivorship; and a civilian site that can serve as an internal control study population.
September 29, 2014
Genomic Health Announces Positive Results from Latest Clinical Validation Study of Oncotype DX® as Predictor of Near- and Long-term Outcomes in Racially Diverse Group of Prostate Cancer Patients
REDWOOD CITY, CA – Genomic Health, Inc. (Nasdaq: GHDX) today announced strongly positive results from an additional independent clinical validation study of the Oncotype DX® prostate cancer test, conducted in collaboration with the Uniformed Services University of the Health Sciences' (USU) Center for Prostate Disease Research (CPDR) supported by a multi-disciplinary team of investigators under a cooperative research and development agreement with USU. This new large study reconfirmed the biopsy-based test's Genomic Prostate Score (GPS) as a predictor of adverse pathology at surgery and, for the first time, validated GPS as a strong independent predictor of a rise in prostate-specific antigen (PSA) following surgery (biochemical recurrence).
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