Prostate CancerPhase 3NCT00809458
Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer
A Phase 3 study testing Vitamin E in people with Prostate Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial summary
The purpose of this study is to find out if vitamin E can help treat prostate cancer. Vitamin E acts primarily as an anti-oxidant. By decreasing the oxidation in the cancer cell, the tumor cells may die. 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?
- Vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Feb 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histologically or cytologically confirmed prostate cancer.
- Patients must have localized prostate cancer and have decided to undergo a prostatectomy or brachytherapy.
- Patient must not be taking supplemental vitamin E.
- Age >18 years.
- Life expectancy of greater than 6 months.
- ECOG performance status =< 2.
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- Patients must have normal organ and marrow function as defined below:
- leukocytes >= 3,000/mcL
- absolute neutrophil count >=1,500/mcL
- platelets >=100,000/mcL
- total bilirubin within normal institutional limits
- AST/ALT =< 2.5 X institutional upper limit of normal
- creatinine =< 1.5 X normal institutional upper limit of normal
- INR =<1.4
- PTT =<1.4 X institutional upper limit of normal
- Patients must have the ability to understand, and the willingness to sign a written informed consent document.
- Only men are eligible for this trial. Members of all races and ethnic groups are eligible for this trial.
Who cannot join
- Patients who have metastatic prostate cancer.
- Patients may not be receiving any other investigational agents.
- Patients with a known bleeding diathesis or patients on therapeutic anticoagulation. (This does not include the use of aspirin but refers to warfarin, heparin, or low molecular weight heparins).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin E.
- The patient may not receive a gonadotrophin release agonist (such as goserelin, or leuprolide), or an antiandrogen (such as bicalutamide, flutamide, or nilutamide) during the study.
- Uncontrolled intercurrent illness that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico - Cancer Center
Albuquerque, New Mexico, 87106
About this study
Official title: A Phase III Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer Prior to Prostatectomy or Brachytherapy
The purpose of this study is to find out if vitamin E can help treat prostate cancer. Vitamin E acts primarily as an anti-oxidant. By decreasing the oxidation in the cancer cell, the tumor cells may die. Vitamin E is a commonly used vitamin that has not been approved by the Food and Drug Administration for use in this type of cancer or for any known cancer. This study will test the hypothesis that vitamin E, in the setting of an oxidative stress such as smoking, can reduce prostate cancer related biomarkers in patients with localized prostate cancer in the neoadjuvant setting.
Read the detailed description
- Prostate Cancer
Prostate cancer is the most common malignancy in American men. It was estimated that nearly 235,000 men in the United States would be diagnosed with prostate cancer and nearly 27,000 men would die. The treatment of localized prostate cancer includes surgery, radiation therapy, or watchful waiting. The relative benefits of these approaches is unclear and treatment choices are individualized and often patient driven. There is currently no proven benefit to receiving preoperative hormonal therapy for patients undergoing radical prostatectomy. As opposed to patients undergoing external beam radiation therapy, for patients undergoing brachytherapy pre treatment hormonal therapy is used in approximately 40% of patients. Thus, these patients offer a unique opportunity to test novel agents in the neoadjuvant setting.
- Vitamin E
The term vitamin E was introduced by Evans and Bishop to describe a dietary factor important for reproduction in rats. Natural vitamin E includes two groups of closely related fat-soluble compounds, the tocopherols and tocotrienols. Eight analogous compounds are widely distributed in nature. Rich, natural sources of vitamin E are edible plant oils. Distinct biological effects of different forms of vitamin E can be distinguished at a molecular level. Vitamin E is the major hydrophobic chain-breaking antioxidant that prevents the propagation of free radical reactions in the lipid components of membranes, vacuoles and plasma lipoproteins.
As an antioxidant, vitamin E acts in cell membranes where it prevents the propagation of free radical reactions. Non-radical oxidation products are formed by the reaction between alpha-tocopheryl radical and other free radicals, which are conjugated to glucuronic acid and excreted through the bile or urine. Vitamin E is transported in plasma lipoproteins.
Most studies of the safety of vitamin E supplementation have lasted for several months or less, so there is little evidence for the long-term safety of vitamin E supplementation. The Food and Nutrition Board of the Institute of Medicine has set an upper tolerable intake level (UL) for vitamin E at 1,000 mg (1,500 IU) for any form of supplementary alpha-tocopherol per day. Based for the most part on the result of animal studies, the Food and Nutrition Board decided that because vitamin E can act as an anticoagulant and may increase the risk of bleeding problems this is the highest dose unlikely to result in bleeding problems (http://dietary-supplements.info.nih.gov/factsheets/vitamin.asp).
The dose of vitamin E used in the Selenium and vitamin E prostate cancer prevention trial (the SELECT trial) was 400 IU per day and thus this is the dose chosen for this study.
- Conditions
- Prostate Cancer
- Being tested
- Vitamin E
- Keywords
- Vitamin E, Prostate Cancer, Alpha-tocopherol (α-tocopherol)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
Also called Alpha-tocopherol (α-tocopherol)
Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Vitamin E) | Experimental | Vitamin E Receives: Drug: Vitamin E |
| Arm 2 | Placebo comparator | Placebo (same vehicle as used for vitamin E) Receives: Drug: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce Biomarkers of Prostate Cancer (PSA Blood Level)
PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of Vitamin E supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.
Measured: 30 days
Secondary outcomes (2)
Determine the Tolerability/Toxicity of a Short Course of Vitamin E in the Neoadjuvant Setting.
- Cardiovascular Effects/ Thrombophlebitis
- Dermatologic Effects
- Gastrointestinal Effects (Gingival bleeding, and gastrointestinal irritations including: diarrhea, nausea, flatulence and stomach cramps)
- Hematologic Effects (Increased bleeding tendencies in vitamin K deficient patients; inhibition of prothrombin production
- Hepatic Effects (Vasculopathic hepatotoxicity and cholestasis)
- Neurologic Effects (Dizziness, headache, fatigue or weakness
- Ophthalmic Effects ( Blurred vision)
- Respiratory Effects (Pulmonary embolism)
Measured: 3 years
Determine Concordance of the Biomarkers in This Setting
The correlation between the ATQ level and the androgen receptor will be explored.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2010
- Study completionFeb 2013
Why it stopped: Low rate of accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Rabinowitz, M.D., Study director, University of New Mexico Cancer CenterRichard Lauer, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809458
- Sponsor's protocol ID
- INST 0808
- Other IDs
- NCI-2011-02662
- Status last verified
- Jun 2015
- First submitted
- 15 Dec 2008
- Last updated
- 16 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer Prior to Prostatectomy or Brachytherapy
- ClinicalTrials.gov ID
- NCT00809458
- Acronym / sponsor ID
- INST 0808
- Conditions
- Prostate Cancer
- Keywords
- Vitamin E, Prostate Cancer, Alpha-tocopherol (α-tocopherol)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low rate of accrual.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 23 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if vitamin E can help treat prostate cancer. Vitamin E acts primarily as an anti-oxidant. By decreasing the oxidation in the cancer cell, the tumor cells may die. Vitamin E is a commonly used vitamin that has not been approved by the Food and Drug Administration for use in this type of cancer or for any known cancer. This study will test the hypothesis that vitamin E, in the setting of an oxidative stress such as smoking, can reduce prostate cancer related biomarkers in patients with localized prostate cancer in the neoadjuvant setting.
Detailed description
- Prostate Cancer
Prostate cancer is the most common malignancy in American men. It was estimated that nearly 235,000 men in the United States would be diagnosed with prostate cancer and nearly 27,000 men would die. The treatment of localized prostate cancer includes surgery, radiation therapy, or watchful waiting. The relative benefits of these approaches is unclear and treatment choices are individualized and often patient driven. There is currently no proven benefit to receiving preoperative hormonal therapy for patients undergoing radical prostatectomy. As opposed to patients undergoing external beam radiation therapy, for patients undergoing brachytherapy pre treatment hormonal therapy is used in approximately 40% of patients. Thus, these patients offer a unique opportunity to test novel agents in the neoadjuvant setting.
- Vitamin E
The term vitamin E was introduced by Evans and Bishop to describe a dietary factor important for reproduction in rats. Natural vitamin E includes two groups of closely related fat-soluble compounds, the tocopherols and tocotrienols. Eight analogous compounds are widely distributed in nature. Rich, natural sources of vitamin E are edible plant oils. Distinct biological effects of different forms of vitamin E can be distinguished at a molecular level. Vitamin E is the major hydrophobic chain-breaking antioxidant that prevents the propagation of free radical reactions in the lipid components of membranes, vacuoles and plasma lipoproteins.
As an antioxidant, vitamin E acts in cell membranes where it prevents the propagation of free radical reactions. Non-radical oxidation products are formed by the reaction between alpha-tocopheryl radical and other free radicals, which are conjugated to glucuronic acid and excreted through the bile or urine. Vitamin E is transported in plasma lipoproteins.
Most studies of the safety of vitamin E supplementation have lasted for several months or less, so there is little evidence for the long-term safety of vitamin E supplementation. The Food and Nutrition Board of the Institute of Medicine has set an upper tolerable intake level (UL) for vitamin E at 1,000 mg (1,500 IU) for any form of supplementary alpha-tocopherol per day. Based for the most part on the result of animal studies, the Food and Nutrition Board decided that because vitamin E can act as an anticoagulant and may increase the risk of bleeding problems this is the highest dose unlikely to result in bleeding problems (http://dietary-supplements.info.nih.gov/factsheets/vitamin.asp).
The dose of vitamin E used in the Selenium and vitamin E prostate cancer prevention trial (the SELECT trial) was 400 IU per day and thus this is the dose chosen for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Vitamin E) | Experimental | Drug: Vitamin EVitamin E |
| Arm 2 | Placebo comparator | Drug: Vitamin EPlacebo (same vehicle as used for vitamin E) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically or cytologically confirmed prostate cancer.
- Patients must have localized prostate cancer and have decided to undergo a prostatectomy or brachytherapy.
- Patient must not be taking supplemental vitamin E.
- Age >18 years.
- Life expectancy of greater than 6 months.
Key exclusion criteria (6 listed)
- Patients who have metastatic prostate cancer.
- Patients may not be receiving any other investigational agents.
- Patients with a known bleeding diathesis or patients on therapeutic anticoagulation. (This does not include the use of aspirin but refers to warfarin, heparin, or low molecular weight heparins).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin E.
- The patient may not receive a gonadotrophin release agonist (such as goserelin, or leuprolide), or an antiandrogen (such as bicalutamide, flutamide, or nilutamide) during the study.
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 |
|---|---|---|
| Vitamin EAlso: Alpha-tocopherol (α-tocopherol)Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy. | Drug | Arm 1 (Vitamin E), Arm 2 |
Primary outcome
Reduce Biomarkers of Prostate Cancer (PSA Blood Level)
Time frame: 30 days
PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of Vitamin E supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.
2 secondary outcomes
Determine the Tolerability/Toxicity of a Short Course of Vitamin E in the Neoadjuvant Setting.
Time frame: 3 years
Determine Concordance of the Biomarkers in This Setting
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- New Mexico Cancer Care AllianceLink provided by the sponsor.
- UNM Cancer CenterLink provided by the sponsor.
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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.
Ian Rabinowitz, M.D. study director
University of New Mexico Cancer Center
Richard Lauer, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin E in people with Prostate Cancer, run by New Mexico Cancer Research Alliance 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 17 inclusion and 6 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: stopped early, as of the sponsor's last update on 16 Jul 2015. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduce Biomarkers of Prostate Cancer (PSA Blood Level) (time frame: 30 days). 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 16 Jul 2015.