NCT00217516

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 9, 2012

Status Verified

September 1, 2010

Enrollment Period

2.9 years

First QC Date

September 20, 2005

Last Update Submit

February 8, 2012

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage I prostate cancerstage II prostate cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral selenium for 3-6 weeks.

Drug: selenium

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo for 3-6 weeks.

Other: placebo

Interventions

seleniumDRUG

Given orally

Arm I
placeboOTHER

Given orally

Arm II

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Selenium

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Michael R. Kuettel, MD, PhD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Primary Completion

February 1, 2008

Study Completion

October 1, 2008

Last Updated

February 9, 2012

Record last verified: 2010-09

Locations

US(1)