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

Study Overview
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Brief Summary
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Laboratory testing has suggested that lithium may decrease the incidence of certain types of cancer, including prostate cancer. Additional research has suggested that lithium decreases prostate cancer tumor size over time. This study will investigate the effect of lithium on men with prostate cancer.

Detailed Description
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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.

Official Title
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Phase 1 Study of Evaluation of Lithium and it's Effect on Clinically Localized Prostate Cancer.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Lithium Carbonate


Participation Criteria
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Eligibility Criteria
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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 </= 1. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lithium<br>Oral lithium carbonate dose escalation: Level 1 of 600 mg/day, then escalating to Level 2 of 900 mg/day, then the final Level 3 of 1200 mg/day. | Drug: Lithium Carbonate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe any change to Performance Status and Adverse Events related to Lithium | To determine the safety and tolerability of lithium in subjects with clinically localized prostate cancer. | Weekly for 4 weeks prior to radical prostatectomy and continuing for 1 - 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lithium levels | To document observed levels of lithium in the serum | Weekly for up to 4 weeks prior to radical prostatectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Lithium, Androgen, PSA