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

NCT ID: NCT02198859

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-08-31

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 tumor size over time. This study will investigate the effect of lithium on men with 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 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lithium

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.

Group Type: EXPERIMENTAL

Lithium Carbonate

Intervention Type: DRUG

Interventions

Lithium Carbonate

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moben Mirza, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

13582

Identifier Type: -

Identifier Source: org_study_id