Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer - Full Text View

Sponsored by:	Roswell Park Cancer Institute
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00217516

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: selenium Other: placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Placebo Control
Official Title:	Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Ataxia Telangiectasia Cancer Dietary Supplements Prostate Cancer

Drug Information available for: Selenium

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility at 1 and 6 months after completion of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effects of selenium on antioxidant enzyme activities at 1 and 6 months after completion of study treatment [ Designated as safety issue: No ]
Threshold effect among patients with low baseline levels of selenium at 1 and 6 months after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2005
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral selenium for 3-6 weeks.	Dietary Supplement: selenium Given orally
Arm II: Placebo Comparator Patients receive oral placebo for 3-6 weeks.	Other: placebo Given orally

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217516

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Principal Investigator:

Michael R. Kuettel, MD, PhD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Roswell Park Cancer Institute ( Michael R. Kuettel )
Study ID Numbers:	CDR0000441225, RPCI-I-14603
Study First Received:	September 20, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00217516 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Selenium
Antioxidants
Prostatic Diseases
Genital Neoplasms, Male
Trace Elements

Urogenital Neoplasms
Micronutrients
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Trace Elements

Genital Diseases, Male
Protective Agents
Pharmacologic Actions
Selenium
Neoplasms
Neoplasms by Site
Micronutrients
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009