Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: placebo (Drug); selenium (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Roswell Park Cancer Institute Official(s) and/or principal investigator(s):
Michael R. Kuettel, MD, PhD, Principal Investigator, Affiliation: Roswell Park Cancer Institute
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 II 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.
Clinical Details
Official title: Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase II
Study design: Treatment, Randomized, Placebo Control
Primary outcome: Effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility at 1 and 6 months after completion of study treatment
Secondary outcome: Effects of selenium on antioxidant enzyme activities at 1 and 6 months after completion of study treatmentThreshold effect among patients with low baseline levels of selenium at 1 and 6 months after completion of study treatment
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: This is a randomized, placebo-controlled study. 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.
PROJECTED ACCRUAL: A total of 160 patients (80 per treatment arm) will be accrued for this
study.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2005
Last updated: June 3, 2008
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