Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study
N/A
N/A
Male
Prostate Cancer
Trial Information
Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility at 1 and 6 months after completion of study treatment
Outcome Time Frame:
1 and 6 months after completion of study treatment
Safety Issue:
No
Principal Investigator
Michael R. Kuettel, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000441225
NCT ID:
NCT00217516
Start Date:
March 2005
Completion Date:
October 2008
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage II prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
