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


Phase 2
N/A
85 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Rate of rise in serum prostate-specific antigen

Safety Issue:

No

Principal Investigator

Frederick R. Ahmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

97-0395-01

NCT ID:

NCT00752739

Start Date:

August 2002

Completion Date:

April 2007

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724