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

This study has been withdrawn prior to enrollment.
(No accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00736164
First received: August 14, 2008
Last updated: February 3, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Dietary Supplement: selenomethionine
Other: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Quantity of androgen receptor message expression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Expression of prostate-specific antigen, kallikrein 2, cell division cycle 6, and dehydrocholesterol reductase 24 [ Designated as safety issue: No ]
  • Expression of haptic nuclear factor 3-alpha [ Designated as safety issue: No ]
  • Variation in thiol methyltransferase phenotype [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2008
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral selenomethionine once daily for 8-9 weeks.
 Dietary Supplement: selenomethionine
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo once daily for 8-9 weeks.
 Other: placebo
Given orally

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736164

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: James L. Mohler, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: James L. Mohler, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00736164     History of Changes
Other Study ID Numbers: CDR0000611981, P30CA016056, RPCI-I-104307
Study First Received: August 14, 2008
Last Updated: February 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:
stage I prostate cancer
stage II prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Selenium
 Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013