Clinical trial · Interventional

Selenium in Preventing Prostate Cancer

Phase III Trial of Selenium for Prostate Cancer Prevention

NCT00978718CI-TRIAL-00007826completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
high-selenium baker's yeast	Dietary Supplement	—	UNRESOLVED
placebo	Other	—	UNRESOLVED
selenium	Dietary Supplement	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
PLACEBO_COMPARATOR
label
Arm I
description
Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
interventionNames
1. Other: placebo
type
EXPERIMENTAL
label
Arm II: 200 μg selenium (Se) as high-Se Baker's yeast daily
description
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.
interventionNames
1. Dietary Supplement: selenium
type
EXPERIMENTAL
label
Arm III: 400 μg Se as high-Se baker's yeast daily

Eligibility

Eligibility (as posted)

Sex: Male
Maximum age: 79 Years

Show eligibility criteria text

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)

References

Publications (0)

Data not yet available

No reference posted for this study.