Docetaxel and Lycopene in Metastatic Prostate Cancer

Inclusion Criteria:

- Subjects must have a histological diagnosis of adenocarcinoma of the prostate and 2
increasing pre-study PSA values, the last of which must be ≥1 ng/ml, at least 1 week
apart.

- Patients must have current or prior evidence of metastatic prostate cancer. Patients
with radiographic evidence of disease progression but without PSA progression may also
be eligible.

- Subjects may have received prior chemotherapy except for a combination of docetaxel
and lycopene. Prior chemotherapy must have been completed at least 1 year prior to
start of treatment under this protocol. Prior biologic therapy, or any investigational
drug must have been completed at least 28 days prior to start of therapy, and the
patient must have recovered from toxicities of prior therapy to grade 1 or less.

- Patients may or may not be surgically or medically castrated. If surgically or
medically castrated, it would be documented by a testosterone level less than 50ng/mL.
If the patient is being treated with medical castration, he must be willing to
continue this treatment for the duration of the study. ADT should not be initiated,
terminated, or dose-adjusted during the study.

- Prior external beam radiation therapy (to less than 30% of the bone marrow only) is
allowed. At least 28 days must have elapsed since the completion of radiation therapy
and the patient must have recovered from side effects. Prior treatment with
samarium-153, radium-223, or strontium-86 is allowed if at least eight weeks have
elapsed since dosing, and all toxicities have resolved to grade 1. Soft tissue disease
which has been radiated in the prior 2 months is not assessable as measurable disease.

- Patients may have received prior surgery. However, at least 21 days must have elapsed
since completion of surgery and the patient must have recovered from all side effects.

- Patient must have adequate hepatic function as defined by 1) a serum bilirubin ≤the
institutional upper limit of normal (IULN), and 2) SGOT or SGPT ≤2.5 x the
institutional upper limit of normal obtained within 14 days prior to start of therapy.
Liver function tests should be evaluated prior to each treatment.

- Patients must have adequate renal function as defined by a serum creatinine ≤1.5 x the
institutional upper limit of normal obtained within 14 days prior to start of therapy.

- Men of child bearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.

- Age > 18

- Patient must have an ECOG performance status 0-2.

- Patients must meet the following hematological criteria (minimal values):

- Absolute neutrophil count > 1,500/mcL

- Hemoglobin of > 8.0gm/dL,

- White blood cell count >2,500/mcL,

- Platelets > 100,000/mcL Patients with lower values may participate if, in the opinion
of the investigator, the cytopenias are the result of bone marrow involvement with
active prostate cancer.

- Patients must be able to take oral medications.

- All patients must be informed and must sign and give written informed consent in
accordance with institutional and federal guidelines. Patients who are unable to
comply with study and/or follow-up procedures are ineligible.

Exclusion Criteria:

- Uncontrolled brain or spinal cord metastases

- History of congestive heart failure or myocardial infarction within the previous six
months.

- History of allergy or hypersensitivity to any component of the study drugs

- Evidence or history of a bleeding diathesis or coagulopathy, including therapy-induced
coagulopathy.

- Presence of chronic diarrhea (> grade 1 by CTC criteria), short bowel
syndrome,pancreatic insufficiency, or malabsorption.

- Presence of any severe or uncontrolled concurrent medical condition which, in the
opinion of the investigator, would increase the risk of serious toxicity from the
study drugs.

- Concurrent use of any vitamin, herb, or mineral supplements containing lycopene for at
least 14 days prior to start of therapy

- Evidence of Grade 2 neuropathy at time of screening.