NCT00736164WithdrawnPhase 2
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)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Primary Endpoint
- Quantity of androgen receptor message expression
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion 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)
Exclusion Criteria
- Not provided
Arms & Interventions
Arm II
Placebo Comparator
Patients receive oral placebo once daily for 8-9 weeks.
Intervention: placebo (Other)
Arm I
Experimental
Patients receive oral selenomethionine once daily for 8-9 weeks.
Intervention: selenomethionine (Dietary Supplement)
Outcomes
Primary Outcomes
Quantity of androgen receptor message expression
Secondary Outcomes
- 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
Investigators
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