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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016056 | U.S. NIH Grant/Contract | View source | |
| RPCI-I-104307 |
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No accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Selenomethionine may slow the growth of prostate cancer. Giving selenomethionine before surgery or internal radiation therapy may be an effective treatment for prostate cancer.
PURPOSE: This randomized phase II trial is studying how well selenomethionine works in treating patients undergoing surgery or internal radiation therapy for stage I or stage II prostate cancer.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: Patients are stratified according to planned treatment (brachytherapy vs prostatectomy). Patients are randomized to 1 of 2 treatment arms.
Blood samples are collected at baseline and on the day of prostatectomy or brachytherapy. Samples are analyzed for selenium accumulation by atomic absorption spectrophotometry. Additional blood samples are stored for future analysis of alpha tocopherol, lycopene, and other vitamin levels, as well as oxidative stress biomarkers. Selenium accumulation is also evaluated in toenail samples at baseline to assess long-term selenium status. Prostate tissue samples are obtained during prostatectomy or brachytherapy and analyzed for RNA and expression of selenium-linked biomarkers (e.g., androgen receptor, prostate-specific antigen, kallikrein 2, cell division cycle 6, dehydrocholesterol reductase 24, and haptic nuclear factor 3 alpha) by quantitative reverse transcription (RT)-PCR. Biomarker expression is compared in both prostatectomy and brachytherapy specimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oral selenomethionine once daily for 8-9 weeks. |
|
| Arm II | Placebo Comparator | Patients receive oral placebo once daily for 8-9 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selenomethionine | Dietary Supplement | Given orally |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of androgen receptor message expression |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of prostate-specific antigen, kallikrein 2, cell division cycle 6, and dehydrocholesterol reductase 24 | ||
| Expression of haptic nuclear factor 3-alpha | ||
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Gleason score < 8
Prostate-specific antigen < 20.0 ng/mL
Scheduled to undergo prostatectomy or brachytherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| James L. Mohler, MD | Roswell Park Cancer Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D012645 | Selenomethionine |
| ID | Term |
|---|---|
| D016566 | Organoselenium Compounds |
| D009930 | Organic Chemicals |
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
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| Other |
Given orally |
|
| Variation in thiol methyltransferase phenotype |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013457 |
| Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |