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

University of Kansas

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: Lithium Carbonate

Study type

Interventional

Funder types

Other

Identifiers

NCT02198859

13582

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.