Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer

As lithium has been shown in an in vitro model to suppress cellular proliferation, and
suppress tumor growth in an in vivo xenograft model, we propose to determine its effect on
prostate cancer cells in human patients undergoing radical prostatectomy. In this pilot
study we plan to assess the toxicity of lithium administration in patients prior to radical
prostatectomy. This will include any clinical toxicity as well as any increase in intra-,
peri- or postoperative complications.

Inclusion Criteria:

- Ability to understand and the willingness to sign a written informed consent form.

- Subjects with histologically confirmed local adenocarcinoma of the prostate who have
elected to proceed with radical prostatectomy as primary curative therapy.

- Subjects having no prior administration of lithium or lithium containing medications
within 90 days of study enrollment.

- Subjects >/= 18 years of age.

- ECOG (Eastern Cooperative Oncology Group) performance status of
- Adequate renal function defined as GFR (Glomerular Filtration Rate) >/= 50 mL/min.

- Use of adequate contraception

- ECG (Electrocardiogram) within normal limits.

- Subjects must agree not to take any new vitamin supplements or herbal remedy during
the study period.

- Subjects must be able to safety take lithium carbonate for at least 4 weeks before
scheduled prostatectomy.

Exclusion Criteria:

- Subjects who have received any investigational medication within 30 days of first
lithium dose.

- Subjects currently receiving, or who have had previous hormonal, chemotherapy or
radiotherapy for prostate cancer.

- Subjects with known brain metastases.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to lithium carbonate.

- Uncontrolled intercurrent illness such as ongoing or active infection, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric
illness/social situations that would limit compliance with study requirements.