Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer

NCT00809458 | Terminated Phase 3 Results DMC

• 2 other identifiers: INST 0808NCI-2011-02662
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

Vitamin E; Prostate Cancer; Alpha-tocopherol (α-tocopherol)

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (2)

• Determine the Tolerability/Toxicity of a Short Course of Vitamin E in the Neoadjuvant Setting.

  3 years

• Determine Concordance of the Biomarkers in This Setting

  3 years

Study Arms (2)

Arm 1 (Vitamin E)

EXPERIMENTAL

Vitamin E

Drug: Vitamin E

Arm 2

PLACEBO COMPARATOR

Placebo (same vehicle as used for vitamin E)

Drug: Vitamin E

Interventions

Vitamin E DRUG

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.

Also known as: Alpha-tocopherol (α-tocopherol)

Arm 1 (Vitamin E); Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Only men are eligible for this trial. Members of all races and ethnic groups are eligible for this trial.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

University of New Mexico - Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Related Links

• New Mexico Cancer Care Alliance
• UNM Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Vitamin E; alpha-Tocopherol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tocopherols

Results Point of Contact

• Title: Richard Lauer, MD
• Organization: UNM Cancer Center

rlauer@salud.unm.edu

505-925-0390

Study Officials

• Ian Rabinowitz, M.D.

  University of New Mexico Cancer Center

  STUDY DIRECTOR

• Richard Lauer, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 17, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: February 1, 2013
• Last Updated: July 16, 2015
• Results First Posted: June 23, 2015

Record last verified: 2015-06

Locations

US (1)