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

Roswell Park Comprehensive Cancer Center

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Other: placebo; Drug: selenium

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00217516

P30CA016056 (U.S. NIH Grant/Contract)

RPCI-I-14603

CDR0000441225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups, including a placebo group

Arm I

Experimental group

Description:

Patients receive oral selenium for 3-6 weeks.

Treatment:

Drug: selenium

Arm II

Placebo Comparator group

Description:

Patients receive oral placebo for 3-6 weeks.

Treatment:

Other: placebo