Selenium in Preventing Prostate Cancer

NCT00978718 | Completed Phase 3

• 4 other identifiers: 01-0506-01R01CA077789P30CA023074UARIZ-99-0045-01,
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Selenium supplements may stop or delay the development of prostate cancer in patients at high risk of prostate cancer. It is not yet known which dose of selenium may be more effective in preventing prostate cancer. PURPOSE: This randomized phase III trial is studying how well selenium works in preventing prostate cancer.

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of biopsy-proven prostate cancer

Secondary Outcomes (2)

• Rate of rise in serum PSA levels

• Evidence of prostate cancer progression as assessed by levels of the serum markers alkaline phosphatase and Chromogranin A

Study Arms (3)

Arm I

PLACEBO COMPARATOR

Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.

Other: placebo

Arm II: 200 μg selenium (Se) as high-Se Baker's yeast daily

EXPERIMENTAL

Patients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.

Dietary Supplement: selenium

Arm III: 400 μg Se as high-Se baker's yeast daily

EXPERIMENTAL

Patients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.

Dietary Supplement: high-selenium baker's yeast

Interventions

high-selenium baker's yeast DIETARY_SUPPLEMENT

Given orally

Also known as: selenium

Arm III: 400 μg Se as high-Se baker's yeast daily

selenium DIETARY_SUPPLEMENT

Given orally

Arm II: 200 μg selenium (Se) as high-Se Baker's yeast daily

placebo OTHER

Given orally

Arm I

Eligibility Criteria

• Age: Up to 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Clinical indicators consistent with the community standards of medical care that would justify a biopsy of the prostate for the diagnosis of cancer, including ≥ 1 of the following: * PSA level above the absolute value of 4 ng/mL or above a published age-ethnic adjusted PSA level appropriate for the community * Rising PSA that should represent a clinically significant PSA velocity (e.g., an estimated annual change in the PSA velocity ≥ 0.75 ng/mL) * Abnormal digital rectal examination of the prostate that identifies a clinically significant change in the prostate (e.g., a prostate nodule or a change in the firmness of the prostate) * Documentation of the clinical assessment that justified the prostate biopsy that allows classification of the patient to high-risk groups * Prostate biopsy negative for cancer within the past 12 months * Prostate biopsy negative for high-grade prostatic intraepithelial neoplasia (PIN) * PIN allowed provided it is grade 1 PATIENT CHARACTERISTICS: * Creatinine \< 2 times upper limit of normal (ULN) * Bilirubin \< 2 times ULN * SGOT and SGPT \< 2 times ULN * Alkaline phosphatase \< 2 times ULN * No history of a prior malignancy except for the following: * Adequately treated basal cell or squamous cell carcinoma * Adequately treated (i.e., complete surgical removal with negative margins) stage I cancer from which the patient is currently in complete remission * Any other cancer from which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior systemic chemotherapy or radiotherapy * At least 90 days since prior and no other concurrent selenium \> 55 μg/day as a dietary supplement (including multivitamin supplements) * More than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modifications, exercise)

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

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: August 1, 2001
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: August 15, 2012

Record last verified: 2012-08