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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198859
• Other study ID #: 13582
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2014
• Last updated: January 6, 2017
• Start date: April 2014
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Lithium Carbonate

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	Yes
Secondary	Serum lithium levels	To document observed levels of lithium in the serum	Weekly for up to 4 weeks prior to radical prostatectomy	No