Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00217516
First received: September 20, 2005
Last updated: February 8, 2012
Last verified: September 2010
  Purpose

RATIONALE: The use of nutritional supplements, such as selenium, may stop prostate cancer from growing. Internal radiation, such as brachytherapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving selenium before brachytherapy may be an effective treatment for prostate cancer.

PURPOSE: This randomized phase I trial is studying selenium to see how well it works compared to placebo in treating patients who are undergoing brachytherapy for stage I or stage II prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: selenium
Other: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility at 1 and 6 months after completion of study treatment [ Time Frame: 1 and 6 months after completion of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of selenium on antioxidant enzyme activities at 1 and 6 months after completion of study treatment [ Time Frame: 1 and 6 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Threshold effect among patients with low baseline levels of selenium at 1 and 6 months after completion of study treatment [ Time Frame: 1 and 6 months after completion of study treatment ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2005
Study Completion Date: October 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral selenium for 3-6 weeks.
Drug: selenium
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo for 3-6 weeks.
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • Compare the effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility, using tissue samples from biopsies before and after treatment, in patients undergoing brachytherapy for stage I or II prostate cancer.

Secondary

  • Determine the effects of selenium on antioxidant enzyme activities in these patients.
  • Determine, preliminarily, whether there is a threshold effect among patients with low baseline levels of selenium treated with this drug.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral selenium for 3-6 weeks. Patients then undergo brachytherapy.
  • Arm II: Patients receive oral placebo for 3-6 weeks. Patients then undergo brachytherapy.

After completion of study treatment, patients are followed at 1 and 6 months.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Must have undergone ≥ a sextant biopsy
    • Clinical stage T1a-T2a disease
  • Gleason score < 8
  • Prostate-specific antigen < 20 ng/mL

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Not specified

Life expectancy

  • More than 5 years

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No other prior malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • No prior hormonal therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

Other

  • More than 30 days since prior and no concurrent participation in another clinical trial involving a medical, surgical, nutritional, or lifestyle intervention (e.g., dietary modification or exercise)
  • No selenium at doses > 50 mcg/day as a dietary supplement, including multivitamin supplements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217516

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Michael R. Kuettel, MD, PhD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00217516     History of Changes
Other Study ID Numbers: CDR0000441225, P30CA016056, RPCI-I-14603
Study First Received: September 20, 2005
Last Updated: February 8, 2012
Health Authority: United States: Food and Drug Administration

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

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 April 14, 2014