Cultured Circulating Tumor Cells in Prostate and Other Cancers

Prostate cancer is the most common cancer in men, with the exception of non-melanomatous skin cancer, and the second leading cause of cancer death among men. According to the Center for Disease Control and United States Cancer Statistics (USCS), in the year 2007 there were 29,093 deaths caused by prostate cancer, and 223,307 men were newly diagnosed with the disease in the United States Given the clinical heterogeneity of this disease as well as the toxicities of current therapies, new prognostic and predictive biomarkers are much needed to facilitate informed therapeutic decision making. A strong correlation between the CTC and the progression of breast, colon and prostate cancers has been demonstrated, being both prognostic and predictive of response to therapy and overall survival. The use of the Veridex CellSearch™ CTC assay has been approved by the FDA to monitor breast and colon cancer therapy. CTCs are a standard of care for monitoring response to prostate cancer treatment, as well. It is likely that changes in the number of CTCs may also be a predictive indicator of treatment response. Techniques utilized in the Veridex Cellsearch™ severely damage CTC in the process, removing the possibility for further study and characterization of the CTC. This study will attempt to improve upon the technology by developing and testing a novel strategy for isolation of intact and viable CTCs, and compare the results to the CellSearch™ benchmark. CTC Development of short or long-term cell lines from these samples would greatly facilitate further characterization of metastasis-producing cells from individual patients. For example, this may allow identification of somatic gene mutations (e.g. in AR) that predict drug therapy responses, global gene and protein expression patterns, drug sensitivity and resistance testing. Following informed consent, all patients will have two 7.5 cc samples of blood drawn at a time when routine blood work related to disease monitoring or treatment is drawn. In addition, those patients with a diagnosis of breast cancer, prostate cancer, or colorectal cancer will have an additional 10cc drawn into a CellSave tube for standard of care CellSearch™ CTC enumeration if their insurance covers the cost. Additional samples will be obtained from selected patients during or following treatment to monitor disease progression or treatment response. Samples will be de-identified and sent to Dr. Goodman's laboratory at Roseman University of Health Sciences. Samples will be processed and results entered into a password-protected database. Results of experiments on the research samples will not be shared with the patient. Results from the CellSearch™ CTC assay will be de-identified by an honest broker and entered into the database. Patient information will also be collected, de-identified and entered into the database. Information will include age, gender, tumor status (TNM), serum LDH, other pertinent standard of care tumor markers (PSA, CEA, or CA 27-29, if available), date of tumor diagnosis, treatment history, date of regional and metastatic progression and date of death (if applicable).