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

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ClinicalTrials.gov Identifier: NCT02198859
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Lithium Carbonate Phase 1

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  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Evaluation of Lithium and it's Effect on Clinically Localized Prostate Cancer.
Study Start Date : April 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Serum lithium levels [ Time Frame: Weekly for up to 4 weeks prior to radical prostatectomy ]
    To document observed levels of lithium in the serum


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198859


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Principal Investigator: Moben Mirza, MD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02198859     History of Changes
Other Study ID Numbers: 13582
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by University of Kansas Medical Center:
Prostate Cancer
Lithium
Androgen
PSA

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs