Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed Any age Other RPCI-I-14603 NCT00217516

Objectives

Primary

1. 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

1. Determine the effects of selenium on antioxidant enzyme activities in these patients.
2. Determine, preliminarily, whether there is a threshold effect among patients with low baseline levels of selenium treated with this drug.

Entry 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

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

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

Expected Enrollment

Outcomes

Effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility at 1 and 6 months after completion of study treatment

Effects of selenium on antioxidant enzyme activities at 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

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Michael Kuettel, MD, PhD, Principal investigator		Ph: 716-845-1562; 800-685-6825

Registry Information
Official Title		Supplementation of L-Selenomethionine in Patients with Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study
Trial Start Date		2005-03-05
Trial Completion Date		2009-11-06 (estimated)
Registered in ClinicalTrials.gov		NCT00217516
Date Submitted to PDQ		2005-07-25
Information Last Verified		2008-10-24
NCI Grant/Contract Number		CA16056

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