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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217516
• Other study ID #: CDR0000441225
• Secondary ID: P30CA016056RPCI-
• Status: Completed
• Phase: Phase 1
• First received: September 20, 2005
• Last updated: February 8, 2012
• Start date: March 2005
• Est. completion date: October 2008

Study information

• Verified date: September 2010
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• selenium
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No