Status:
COMPLETED
Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02198859
Start Date
April 1 2014
End Date
August 1 2016
Last Update
January 9 2017
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160