Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
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 [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 [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 [1 and 6 months after completion of study treatment]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
Sponsors and Collaborators
- Roswell Park Cancer Institute
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Michael R. Kuettel, MD, PhD, Roswell Park Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000441225
- P30CA016056
- RPCI-I-14603