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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
selenium
placebo
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients receive oral selenium for 3-6 weeks.

Patients receive oral placebo for 3-6 weeks.

Outcomes

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

Secondary Outcome Measures

Effects of selenium on antioxidant enzyme activities at 1 and 6 months after completion of study treatment
Threshold effect among patients with low baseline levels of selenium at 1 and 6 months after completion of study treatment

Full Information

First Posted
September 20, 2005
Last Updated
February 8, 2012
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00217516
Brief Title
Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer
Official Title
Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral selenium for 3-6 weeks.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo for 3-6 weeks.
Intervention Type
Drug
Intervention Name(s)
selenium
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R. Kuettel, MD, PhD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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