NCT02198859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

July 7, 2014

Last Update Submit

January 6, 2017

Conditions

Prostate Cancer

Keywords

Prostate CancerLithiumAndrogenPSA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Serum lithium levels

    Weekly for up to 4 weeks prior to radical prostatectomy

Other Outcomes (1)

  • Tumor response by lithium concentration

    Sample collected during surgery and up to 4 weeks after baseline

Study Arms (1)

Lithium

EXPERIMENTAL

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

Interventions

Lithium CarbonateDRUG
Lithium

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium Compounds

Study Officials

  • Moben Mirza, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 24, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

US(1)