Selenium in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Chemoprevention Trial of Selenium and Prostate Cancer (Watchful Waiting With Selenium Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752739
• Other study ID #: 97-0395-01
• Secondary ID: R01CA079080P30CA
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2008
• Last updated: August 13, 2012
• Start date: August 2002
• Est. completion date: April 2007

Study information

• Verified date: August 2012
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• To investigate the ability of selenium to prevent progression in patients with adenocarcinoma of the prostate.

• To investigate the ability of selenium to effectively modulate biomarkers of prostate cancer.

• To determine if selenium modifies the progression of prostate cancer based on an analysis of initial biopsy, subsequent blood biomarkers, and urological symptoms.

• To further establish the safety of chronic supplementation with selenium in these patients.

OUTLINE: Patients are stratified according to Gleason score (low vs moderate). Patients are randomized to 1 of 3 treatment arms.

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

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

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

Blood and tissue samples are collected periodically for biomarker laboratory studies. Blood samples are analyzed for levels of prostate-specific antigen, chromogranin A, alkaline phosphatase, alpha tocopherol, lycopene, and other vitamins; levels of selenium by atomic absorption spectrometry; and oxidative damage to DNA. Tissue samples are analyzed for levels of Bcl-2, p53, Ki-67, thioredoxin reductase, thioredoxin, and glutathione peroxidase by immunohistochemistry and for apoptotic index by TUNEL assay.

Patients complete urological symptom questionnaires and other questionnaires periodically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• selenium
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of rise in serum prostate-specific antigen			No
Primary	Rate of rise in chromogranin A and alkaline phosphatase			No
Primary	Disease progression			No
Secondary	Time to prostate cancer therapy			No
Secondary	Time to metastases			No
Secondary	Symptoms of selenium toxicity			Yes