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).

Inclusion Criteria:

- Diagnosis of prostate cancer, breast cancer, or other cancer, OR have no cancer. All
participants will be having blood drawn at Comprehensive Cancer Centers of Nevada as
part of their routine care.

- 18 years of age or older.

- All participants must be informed of the investigational nature of this study, and
must sign and give written informed consent in accordance with institutional and FDA
guidelines.

Exclusion Criteria: