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

Information source: University of Kansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Lithium Carbonate (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Kansas

Official(s) and/or principal investigator(s):
Moben Mirza, MD, Principal Investigator, Affiliation: University of Kansas

Overall contact:
Moben Mirza, MD, Phone: 913-945-6432, Email: mmirza@Kumc.edu


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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Observe any change to Performance Status and Adverse Events related to Lithium

Secondary outcome: Serum lithium levels

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 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


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.

Locations and Contacts

Moben Mirza, MD, Phone: 913-945-6432, Email: mmirza@Kumc.edu

University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Moben Mirza, MD, Phone: 913-945-6432, Email: mmirza@kumc.edu
Mary Dressler, Phone: 913-945-5791, Email: mdressler@kumc.edu
Moben Mirza, MD, Principal Investigator
Jeffrey Holzbeierlein, MD, Sub-Investigator
J. Brantley Thrasher, MD, Sub-Investigator
David Duchene, MD, Sub-Investigator
Eugene Lee, MD, Sub-Investigator
Peter VanVeldhuizen, MD, Sub-Investigator
Greg Reed, PhD, Sub-Investigator
Additional Information

Starting date: April 2014
Last updated: March 31, 2015

Page last updated: August 23, 2015

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