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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Lithium Carbonate

• Registration Number: NCT02198859
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-24
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lithium	Lithium Carbonate	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum lithium levels	Weekly for up to 4 weeks prior to radical prostatectomy	To document observed levels of lithium in the serum

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States