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

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: Prostate Cancer
• Intervention / Treatment: Drug: Lithium Carbonate

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	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

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

Study record dates

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: PSA; Prostate Cancer; Lithium; Androgen
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: 13582