Clinical trial · Interventional
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.
NCT02198859CI-TRIAL-00025405completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lithium Carbonate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lithium
- description
- 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.
- interventionNames
- Drug: Lithium Carbonate
Primary outcomes (1)
- 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
- description
- To determine the safety and tolerability of lithium in subjects with clinically localized prostate cancer.
Secondary outcomes (1)
- measure
- Serum lithium levels
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.