Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02198859|
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Lithium Carbonate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Evaluation of Lithium and it's Effect on Clinically Localized Prostate Cancer.|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
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
- Observe any change to Performance Status and Adverse Events related to Lithium [ Time Frame: Weekly for 4 weeks prior to radical prostatectomy and continuing for 1 - 2 weeks after surgery ]To determine the safety and tolerability of lithium in subjects with clinically localized prostate cancer.
- Serum lithium levels [ Time Frame: Weekly for up to 4 weeks prior to radical prostatectomy ]To document observed levels of lithium in the serum
- Tumor response by lithium concentration [ Time Frame: Sample collected during surgery and up to 4 weeks after baseline ]To evaluate tumor response by lithium concentration in the surgically removed prostate and serum PSA levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198859
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Moben Mirza, MD||University of Kansas Medical Center|