Back to resultsEvaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lithium Carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Lithium, Androgen, PSA
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.
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lithium
Arm Description
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.
Outcomes
Primary Outcome Measures
Observe any change to Performance Status and Adverse Events related to Lithium
To determine the safety and tolerability of lithium in subjects with clinically localized prostate cancer.
Secondary Outcome Measures
Serum lithium levels
To document observed levels of lithium in the serum
Full Information
NCT ID
NCT02198859
First Posted
July 7, 2014
Last Updated
January 6, 2017
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02198859
Brief Title
Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer
Official Title
Phase 1 Study of Evaluation of Lithium and it's Effect on Clinically Localized Prostate Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Lithium, Androgen, PSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lithium
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Primary Outcome Measure Information:
Title
Observe any change to Performance Status and Adverse Events related to Lithium
Description
To determine the safety and tolerability of lithium in subjects with clinically localized prostate cancer.
Time Frame
Weekly for 4 weeks prior to radical prostatectomy and continuing for 1 - 2 weeks after surgery
Secondary Outcome Measure Information:
Title
Serum lithium levels
Description
To document observed levels of lithium in the serum
Time Frame
Weekly for up to 4 weeks prior to radical prostatectomy
Other Pre-specified Outcome Measures:
Title
Tumor response by lithium concentration
Description
To evaluate tumor response by lithium concentration in the surgically removed prostate and serum PSA levels.
Time Frame
Sample collected during surgery and up to 4 weeks after baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moben Mirza, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer
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