Prostate CancerPhase 1NCT02198859
Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer
A Phase 1 study testing Lithium Carbonate in people with Prostate Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Lithium Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Phase 1 Study of Evaluation of Lithium and it's Effect on Clinically Localized Prostate Cancer.
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Lithium Carbonate
- Keywords
- Prostate Cancer, Lithium, Androgen, PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium CarbonateDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lithium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly for 4 weeks prior to radical prostatectomy and continuing for 1 - 2 weeks after surgery
Secondary outcomes (1)
Serum lithium levels
To document observed levels of lithium in the serum
Measured: Weekly for up to 4 weeks prior to radical prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moben Mirza, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198859
- Sponsor's protocol ID
- 13582
- Status last verified
- Jan 2017
- First submitted
- 7 Jul 2014
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Evaluation of Lithium and it's Effect on Clinically Localized Prostate Cancer.
- ClinicalTrials.gov ID
- NCT02198859
- Acronym / sponsor ID
- 13582
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Lithium, Androgen, PSA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithium | Experimental | Drug: Lithium CarbonateOral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium Carbonate | Drug | Lithium |
Primary outcome
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.
1 secondary outcome
Serum lithium levels
Time frame: Weekly for up to 4 weeks prior to radical prostatectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moben Mirza, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lithium Carbonate in people with Prostate Cancer, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.