Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising Prostate Specific Antigen (PSA) on Hormone Therapy

Patients with prostate cancer who are treated with surgery or radiation often develop
recurrence of their cancer which is manifest only by a rising PSA (Prostate Specific
Antigen) level. Many of these patients are treated with hormone therapy. After a fall in
the PSA, these patients eventually display evidence of tumor progression clearly
demonstrated by another rise in PSA level while receiving hormone therapy. Evaluation for
evidence of tumor spread is usually negative. There is currently no effective therapy
approved for use in these patients.

The drug erlotinib works by blocking the activity of a protein called Epidermal Growth
Factor Receptor (EGFR), which is located on the surface of many prostate cancer cells.
Blockage of this protein has been shown to inhibit the growth of prostate tumor cells in a
laboratory setting and in animal experiments. Erlotinib has been given to patients with
other types of cancers. A recently completed study showed that erlotinib improved the
survival of patients with advanced lung cancer who failed standard chemotherapy.

There is currently no effective therapy approved for use in patients with this condition.
The purpose of this study is to evaluate the effectiveness and side effects of the drug
erlotinib in patients with this condition. Erlotinib is an investigational drug that has
not yet been approved by the Federal Drug Administration (FDA) for use in prostate cancer,
but has been approved for use in lung cancer.

As previously stated: The primary objective of this study is to evaluate the effect of
erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a
rising PSA on androgen deprivation therapy.

Secondary objectives are to evaluate the effect of erlotinib on the duration of PSA
response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of
erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with
various EGFR-related proteins using baseline immunohistochemical (IHC) studies on tissue
blocks and peripheral blood mononuclear cells.