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WithdrawnNCT00736164Updated Feb 6, 2012

Selenomethionine in Treating Patients Undergoing Surgery or Internal Radiation Therapy for Stage I or Stage II Prostate Cancer

A Phase 2 interventional study of selenomethionine and placebo in Prostate Cancer, sponsored by Roswell Park Cancer Institute. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-06.

Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment

Why this study was withdrawn
No accrual
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • stage I prostate cancer
  • stage II prostate cancer
  • adenocarcinoma of the prostate
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

Browse Prostatic Neoplasms studies →

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Masking
Double
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Arm I

    Patients receive oral selenomethionine once daily for 8-9 weeks.

    Dietary Supplement: selenomethionine

  • Placebo comparator
    Arm II

    Patients receive oral placebo once daily for 8-9 weeks.

    Other: placebo

Interventions

  • Dietary supplementselenomethionine

    Given orally

  • Otherplacebo

    Given orally

06

What researchers measure

Primary outcomes

  1. Quantity of androgen receptor message expression

Secondary outcomes

  1. Expression of prostate-specific antigen, kallikrein 2, cell division cycle 6, and dehydrocholesterol reductase 24

  2. Expression of haptic nuclear factor 3-alpha

  3. Variation in thiol methyltransferase phenotype

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00736164
Lead sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
First posted
Aug 15, 2008
Start date
Aug 2008
Primary completion
Jun 2012 (estimated)
Last update
Feb 6, 2012

Study contacts

James L. Mohler, MD
principal investigator · Roswell Park Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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