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Phase III Trial of Selenium for Prostate Cancer Prevention


Phase 3
N/A
79 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Phase III Trial of Selenium for Prostate Cancer Prevention


OBJECTIVES:

- To determine whether selenium (Se) supplementation decreases the incidence of prostate
cancer.

- To determine whether Se supplementation inhibits the biochemical progression of
prostate cancer.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.

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

- Arm II: 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.

- Arm III: 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.

Blood samples are collected at baseline, at randomization, and then semi-annually for
laboratory and other testing. Tissue samples may also be collected for biomarker analysis.
Patients complete an initial questionnaire and urological-symptoms questionnaire at
baseline, a follow-up questionnaire after randomization (to capture new illness,
medications, and toxicity symptoms during the 30-day run-in period; a urological-symptoms
questionnaire; a food-frequency questionnaire; and a mood questionnaire). Patients then
undergo questionnaires semi-annually, including vital status, tablet compliance, nutrition,
mood, new illnesses or medications, and any incidence of cancer or family history of
cancer).

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Incidence of biopsy-proven prostate cancer

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:

01-0506-01

NCT ID:

NCT00978718

Start Date:

August 2001

Completion Date:

June 2004

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms

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