Selenium in Treating Patients With Prostate Cancer

NCT00752739 | Completed Phase 2

• 6 other identifiers: 97-0395-01R01CA079080P30CA023074UARIZ-97-0395UARIZ-HSC-97-57DAMD17-98-1-8580
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Selenium may prevent or slow the growth of prostate cancer. PURPOSE: This randomized phase II trial is studying how well selenium works in treating patients with prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (3)

• Rate of rise in serum prostate-specific antigen

• Rate of rise in chromogranin A and alkaline phosphatase

• Disease progression

Secondary Outcomes (3)

• Time to prostate cancer therapy

• Time to metastases

• Symptoms of selenium toxicity

Study Arms (3)

Arm I

PLACEBO COMPARATOR

Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity.

Other: placebo

Arm II

EXPERIMENTAL

Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.

Dietary Supplement: selenium

Arm III

EXPERIMENTAL

Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.

Dietary Supplement: selenium

Interventions

selenium DIETARY_SUPPLEMENT

Given orally

Arm II; Arm III

placebo OTHER

Given orally

Arm I

Eligibility Criteria

• Age: Up to 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Biopsy-proven adenocarcinoma of the prostate within the past 48 months * Prostate-specific antigen \< 50 ng/mL * Gleason score \< 8 * Currently undergoing "watchful waiting" for prostate cancer * No metastatic disease PATIENT CHARACTERISTICS: * Life expectancy ≥ 3 years * AST and ALT ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 1.5 times ULN * Bilirubin ≤ 1.5 times ULN * Creatinine ≤ 1.5 times ULN * No other malignancy within the past 5 years, except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: * No prior hormone therapy, radiotherapy, chemotherapy, or surgery for prostate cancer * At least 90 days since prior and no concurrent selenium (as a dietary supplement or as part of a multivitamin) exceeding 50 mcg/day

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

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Selenium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Frederick R. Ahmann, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 15, 2008
• Study Start: August 1, 2002
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

US (1)