Prostate Cancer Clinical Trial
Official title:
Cultured Circulating Tumor Cells - Development of a Novel Platform for Drug Discovery and in Vitro Chemosensitivity Testing in Prostate and Other Cancers
The purpose of this study is to evaluate the number of circulating tumor cells (CTC) before
and after treatment using an experimental method for detecting CTC, compared to commercial
CTC assay results, in patients with prostate, breast or colorectal cancers.
Experiments will be done to develop a new assay technique and also test how CTC react to
commonly used drugs. This information will be analyzed to determine if the experimental
assays can be helpful in the future to predict how a patient's cancer may react to certain
treatments.
The research experiments will also attempt to grow CTC for long-term or "immortal" cell
lines that can be further studied for proteins and gene mutations related to the specific
tumor (not familial), and testing for sensitivity to drugs.
Blood samples will be collected at specific time points during routine medical care from
patients with prostate, breast, colorectal or other solid tumor cancer. Samples will also be
collected from patients with no cancer for comparison purposes. Samples for the experimental
tests will be identified only by codes and results will not be shared with participants.
Patients with prostate, breast or colorectal cancer will also have blood samples drawn for
commercial CTC assays as part of their standard care.
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).
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Observational Model: Cohort, Time Perspective: Prospective
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