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

Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00217516

Enrollment

Registered

2005-09-22

Start date

2005-03-31

Completion date

2008-10-31

Last updated

2012-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer

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.

Interventions

DRUGselenium

Given orally

OTHERplacebo

Given orally

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026