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

January 6, 2017 updated by: University of Kansas Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Lithium Carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observe any change to Performance Status and Adverse Events related to Lithium
Time Frame: 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.
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
Time Frame: Weekly for up to 4 weeks prior to radical prostatectomy
To document observed levels of lithium in the serum
Weekly for up to 4 weeks prior to radical prostatectomy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response by lithium concentration
Time Frame: Sample collected during surgery and up to 4 weeks after baseline
To evaluate tumor response by lithium concentration in the surgically removed prostate and serum PSA levels.
Sample collected during surgery and up to 4 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Moben Mirza, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13582

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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