Selenomethionine in Treating Patients Undergoing Surgery or Internal Radiation Therapy for Stage I or Stage II Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
selenomethionine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
- Diagnosed by sextant or greater biopsy
- Clinical stage T1a-T2c disease
- Gleason score < 8
- Prostate-specific antigen < 20.0 ng/mL
- Scheduled to undergo prostatectomy or brachytherapy
PATIENT CHARACTERISTICS:
- Life expectancy > 5 years
- No other prior malignancy except nonmelanoma skin cancer
- Willing to take selenomethionine or placebo for 8-9 weeks immediately prior to undergoing prostatectomy or brachytherapy
PRIOR CONCURRENT THERAPY:
- No prior hormonal therapy or radiotherapy
- More than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or lifestyle intervention (e.g., dietary modification or exercise)
- No concurrent dietary supplementation with selenium at doses > 60 mcg/day, including multivitamin supplements
- No concurrent hormonal therapy, including 5-alpha reductase inhibitors (e.g., finasteride or dutasteride); anti-androgens (e.g., bicalutamide, flutamide, or ketoconazole); or luteinizing hormone-releasing hormone agonists (e.g., leuprolide acetate, goserelin acetate, or abarelix)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm I
Arm II
Arm Description
Patients receive oral selenomethionine once daily for 8-9 weeks.
Patients receive oral placebo once daily for 8-9 weeks.
Outcomes
Primary Outcome Measures
Quantity of androgen receptor message expression
Secondary Outcome Measures
Expression of prostate-specific antigen, kallikrein 2, cell division cycle 6, and dehydrocholesterol reductase 24
Expression of haptic nuclear factor 3-alpha
Variation in thiol methyltransferase phenotype
Full Information
NCT ID
NCT00736164
First Posted
August 14, 2008
Last Updated
February 3, 2012
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00736164
Brief Title
Selenomethionine in Treating Patients Undergoing Surgery or Internal Radiation Therapy for Stage I or Stage II Prostate Cancer
Official Title
A Randomized, Double Blind, Placebo Controlled Clinical Trial of Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Prostatectomy or Brachytherapy (Se Pre-Prostatectomy/Pre-Brachytherapy Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Why Stopped
No accrual
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Selenomethionine may slow the growth of prostate cancer. Giving selenomethionine before surgery or internal radiation therapy may be an effective treatment for prostate cancer.
PURPOSE: This randomized phase II trial is studying how well selenomethionine works in treating patients undergoing surgery or internal radiation therapy for stage I or stage II prostate cancer.
Detailed Description
OBJECTIVES:
Primary
To investigate the down-regulation of the androgen receptor using tissue samples from patients with stage I or II prostate cancer treated with selenomethionine for 8-9 weeks prior to undergoing prostatectomy or brachytherapy.
Secondary
To evaluate the down regulation of a number of genes regulated by the androgen receptor (i.e., prostate-specific antigen, kallikrein 2, cell division cycle 6, and dehydrocholesterol reductase 24) using tissue samples from these patients.
To evaluate the down-regulation of haptic nuclear factor 3-alpha using tissue samples from these patients.
To evaluate whether the thiol methyltransferase phenotype modifies the prostatic response to short-term selenomethionine supplementation in these patients.
Tertiary
To use quantitative nuclear morphometry to index cellular abnormality in tissue samples as measured by nuclear texture (e.g., total optical density, nuclear area, mean nuclear density, and optical heterogeneity).
OUTLINE: Patients are stratified according to planned treatment (brachytherapy vs prostatectomy). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral selenomethionine once daily for 8-9 weeks. Patients then undergo prostatectomy or brachytherapy.
Arm II: Patients receive oral placebo once daily for 8-9 weeks. Patients then undergo prostatectomy or brachytherapy.
Blood samples are collected at baseline and on the day of prostatectomy or brachytherapy. Samples are analyzed for selenium accumulation by atomic absorption spectrophotometry. Additional blood samples are stored for future analysis of alpha tocopherol, lycopene, and other vitamin levels, as well as oxidative stress biomarkers. Selenium accumulation is also evaluated in toenail samples at baseline to assess long-term selenium status. Prostate tissue samples are obtained during prostatectomy or brachytherapy and analyzed for RNA and expression of selenium-linked biomarkers (e.g., androgen receptor, prostate-specific antigen, kallikrein 2, cell division cycle 6, dehydrocholesterol reductase 24, and haptic nuclear factor 3 alpha) by quantitative reverse transcription (RT)-PCR. Biomarker expression is compared in both prostatectomy and brachytherapy specimens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral selenomethionine once daily for 8-9 weeks.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo once daily for 8-9 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
selenomethionine
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Quantity of androgen receptor message expression
Secondary Outcome Measure Information:
Title
Expression of prostate-specific antigen, kallikrein 2, cell division cycle 6, and dehydrocholesterol reductase 24
Title
Expression of haptic nuclear factor 3-alpha
Title
Variation in thiol methyltransferase phenotype
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Diagnosed by sextant or greater biopsy
Clinical stage T1a-T2c disease
Gleason score < 8
Prostate-specific antigen < 20.0 ng/mL
Scheduled to undergo prostatectomy or brachytherapy
PATIENT CHARACTERISTICS:
Life expectancy > 5 years
No other prior malignancy except nonmelanoma skin cancer
Willing to take selenomethionine or placebo for 8-9 weeks immediately prior to undergoing prostatectomy or brachytherapy
PRIOR CONCURRENT THERAPY:
No prior hormonal therapy or radiotherapy
More than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or lifestyle intervention (e.g., dietary modification or exercise)
No concurrent dietary supplementation with selenium at doses > 60 mcg/day, including multivitamin supplements
No concurrent hormonal therapy, including 5-alpha reductase inhibitors (e.g., finasteride or dutasteride); anti-androgens (e.g., bicalutamide, flutamide, or ketoconazole); or luteinizing hormone-releasing hormone agonists (e.g., leuprolide acetate, goserelin acetate, or abarelix)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James L. Mohler, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Selenomethionine in Treating Patients Undergoing Surgery or Internal Radiation Therapy for Stage I or Stage II Prostate Cancer
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