- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00809458
Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer
A Phase III Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer Prior to Prostatectomy or Brachytherapy
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- University of New Mexico - Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
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.
Exclusion Criteria:
- 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.
Inclusion of Women and Minorities
- Only men are eligible for this trial. Members of all races and ethnic groups are eligible for this trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1 (Vitamin E)
Vitamin E
|
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.
Other Names:
|
Placebo Comparator: Arm 2
Placebo (same vehicle as used for vitamin E)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the Tolerability/Toxicity of a Short Course of Vitamin E in the Neoadjuvant Setting.
Time Frame: 3 years
|
|
3 years
|
Determine Concordance of the Biomarkers in This Setting
Time Frame: 3 years
|
The correlation between the ATQ level and the androgen receptor will be explored.
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ian Rabinowitz, M.D., University of New Mexico Cancer Center
- Principal Investigator: Richard Lauer, MD, University of New Mexico
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INST 0808
- NCI-2011-02662 (Registry Identifier: NCI Clinical Trials Reporting Program)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Vitamin E
-
National Institute of Diabetes and Digestive and...Completed
-
Hospital General Universitario ElcheCompleted
-
Shiraz University of Medical SciencesCompletedRestless Legs Syndrome | Kidney Failure, ChronicIran, Islamic Republic of
-
Aesculap AGRaylytic GmbH; B. Braun Medical FranceRecruitingArthritis, Rheumatoid | Osteoarthritis, Knee | Joint Instability | Intra-Articular Fractures | Genu Valgum or VarumFrance, Germany
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...CompletedChronic Arsenic PoisoningBangladesh
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedBreast Cancer | FatigueUnited States
-
University of Health Sciences LahoreCompleted
-
Hospital General Universitario ElcheCompletedSurgical Site Infection
-
University Hospital, GenevaCompleted