Overview

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

Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Roswell Park Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Treatments:
Selenium
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