Study
PLCO
(Learn more about this study)
Project ID
2009-0063
Initial CDAS Request Approval
May 26, 2009
Title
Cancer Recurrence after Diagnosis of Clinically Localized Prostate Cancer
Summary
A follow-up study within the current setting of the PLCO trial has the potential to make a significant and unique contribution to the literature on prostate cancer progression. Many of the current progression studies are retrospective, and therefore, are lacking potentially important pieces of information on patient demographic and clinical characteristics as well as biological samples that could further inform risk. In contrast, the PLCO study collected substantial information prospectively including questionnaire-based lifestyle factors at baseline and on the supplemental questionnaire, serial prediagnostic PSA values to study PSA kinetics, serum and tissue samples, and a genome-wide scan and hormone data for selected cases. Current infrastructure is in place for long-term mortality follow-up, however, clinical follow-up is limited to one-year post-diagnosis. The proposed work would fill in the clinical follow-up of all clinically localized prostate cancer cases (~5,800 subjects) by mail survey (with phone follow-up) for report of prostate cancer biochemical (rising PSA) or tumor recurrence, assessment of quality of life, medical record verification for potential cases (~850 cases) and a tissue sample request for those men who received radical prostatectomy and have not already been contacted by PLCO with regard to their tissue samples. PLCO is an ideal cohort to evaluate additional risk factors for prostate cancer recurrence and progression, verify intermediate endpoints, and evaluate survivorship issues related to treatment and quality of life.
Aims
Goal: To establish a cohort that follows the natural history of prostate cancer progression among men who were diagnosed with clinically localized prostate cancer while participating in the PLCO trial. Primary aims <!--[if !supportLists]-->1) <!--[endif]--> To establish a resource within which determinants (lifestyle, genetic) and early biomarkers relevant to prostate cancer progression among men with clinically localized prostate cancer can be identified. <!--[if !supportLists]-->2) <!--[endif]-->To verify intermediate endpoints in this PLCO follow-up study. Secondary Aim <!--[if !supportLists]-->1) <!--[endif]-->To evaluate survivorship issues among men diagnosed and treated for clinically localized prostate cancer including the impact of recurrence, secondary treatment, concurrent co-morbidities, and second primary cancers on quality of life.
Collaborators
Gerry Andriole (Washington University)
Bob Hoover (Division Cancer Epidemiology and Genetics)
Karen Broski (Henry Ford Health System)
Adam Kibel (Washington University)
Lois Lamerato (Henry Ford Health System)
Heidi Lowery (Washington University)
Richard Hayes (New York University School of Medicine)
Siobhan Sutcliffe (Washington University)
Kathryn Taylor (Georgetown University)
