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

Sponsor:	Roswell Park Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Roswell Park Cancer Institute
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	Drug: selenium Other: placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: Cancer Prostate Cancer

Drug Information available for: Selenomethionine Selenium

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 and 6 months after completion of study treatment ] [ Designated as safety issue: No ]

Enrollment:	18
Study Start Date:	March 2005
Study Completion Date:	October 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

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

National Cancer Institute (NCI)

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
ClinicalTrials.gov Identifier:	NCT00217516 History of Changes
Other Study ID Numbers:	CDR0000441225, P30CA016056, RPCI-I-14603
Study First Received:	September 20, 2005
Last Updated:	February 8, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:

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

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Selenium

Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012