Clinical trial NCT02198859: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lithium
Androgen
PSA
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Observe any change to Performance Status and Adverse Events related to Lithium
timeFrame: Weekly for 4 weeks prior to radical prostatectomy and continuing for 1 - 2 weeks after surgery
Secondary outcomes:
measure: Serum lithium levels
timeFrame: Weekly for up to 4 weeks prior to radical prostatectomy
Other outcomes:
measure: Tumor response by lithium concentration
timeFrame: Sample collected during surgery and up to 4 weeks after baseline
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Moben Mirza, MD
role: PRINCIPAL_INVESTIGATOR
References: