Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA079080 | U.S. NIH Grant/Contract | View source | |
| P30CA023074 | U.S. NIH Grant/Contract | View source | |
| UARIZ-97-0395 | |||
| UARIZ-HSC-97-57 | |||
| DAMD17-98-1-8580 | |||
| 97-0395-01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
OUTLINE: Patients are stratified according to Gleason score (low vs moderate). Patients are randomized to 1 of 3 treatment arms.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Placebo Comparator | Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity. |
|
| Arm II | Experimental | Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity. |
|
| Arm III | Experimental | Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selenium | Dietary Supplement | Given orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of rise in serum prostate-specific antigen | ||
| Rate of rise in chromogranin A and alkaline phosphatase | ||
| Disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Time to prostate cancer therapy | ||
| Time to metastases | ||
| Symptoms of selenium toxicity |
Not provided
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frederick R. Ahmann, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | 85724 | United States |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012643 | Selenium |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Other |
Given orally |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |