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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA037429 | U.S. NIH Grant/Contract | View source | |
| S9917 | Other Identifier | SWOG | |
| CALGB-70004 | Other Identifier | CALGB | |
| NCI-P02-0203 | Other Identifier | NCI grant |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Eastern Cooperative Oncology Group | NETWORK |
| Cancer and Leukemia Group B | NETWORK |
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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate.
PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate.
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (40-60 vs 61 and over), race (African American vs other), baseline PSA (less than 4 ng/mL vs 4-10 ng/mL), concurrent vitamin E supplementation (yes vs no), and cores obtained from initial biopsy (10 or more vs less than 10). Patients are randomized to 1 of 2 arms.
Patients are followed every 6 months for 2 years and then annually for 8 years.
PROJECTED ACCRUAL: A total of 465 patients will be randomized for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-selenomethionine | Active Comparator | L-selenomethionine (Selenium)one tablet by mouth daily for 3 years. |
|
| L-selenomethionine placebo | Placebo Comparator | L-selenomethionine placebo one tablet by mouth daily for 3 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-selenomethionine | Drug | Randomization between active L-selenomethionine and placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Carcinoma of the Prostate as Measured by Biopsy | The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. | 3 months after randomization and then every 3 months for 3 years |
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DISEASE CHARACTERISTICS:
Diagnosis of high-grade prostatic intraepithelial neoplasia with no evidence of cancer
Documented by a digital rectal exam and biopsy of the prostate with transrectal ultrasound guidance (required if fewer than 6 cores obtained in biopsy) meeting one of the following conditions:
PSA ≤ 10 ng/mL (≤ 5 ng/mL for patients who have received finasteride or other androgen suppressor within the past 2 months)
American Urological Association symptom score of less than 20
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Jim Marshall, PhD | Roswell Park Cancer Institute | Study Chair |
| David Jarrard, MD | University of Wisconsin, Madison | Study Chair |
| W. Robert Lee, MD | Wake Forest University Health Sciences | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16896036 | Result | Marshall JR, Sakr W, Wood D, Berry D, Tangen C, Parker F, Thompson I, Lippman SM, Lieberman R, Alberts D, Jarrard D, Coltman C, Greenwald P, Minasian L, Crawford ED. Design and progress of a trial of selenium to prevent prostate cancer among men with high-grade prostatic intraepithelial neoplasia. Cancer Epidemiol Biomarkers Prev. 2006 Aug;15(8):1479-84. doi: 10.1158/1055-9965.EPI-05-0585. | |
| Result | Sakr WA, Faulkner JR, Wood D: Low rate of confirming prostate cancer on repeat biopsies following diagnosis of high grade prostatic intraepithelial neoplasia: preliminary analysis of Southwest Oncology Group study s9917. [Abstract] Proceedings of the American Association for Cancer Research 45: A-1333, 305, 2004. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | |
| FG001 | Selenium | Patients receive oral selenium once daily for 3 years |
| FG002 | Placebo | Patients receive oral placebo once daily for 3 years |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Registration |
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| ||||||||||||||||||
| Randomization |
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| ID | Title | Description |
|---|---|---|
| BG000 | Selenium | Patients receive oral selenium once daily for 3 years |
| BG001 | Placebo | Patients receive oral placebo once daily for 3 years |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Presence of Carcinoma of the Prostate as Measured by Biopsy | The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy. | All eligible randomized patients who started treatment and have prostate cancer known through an interim biopsy or a biopsy taken at +/- 90 days of the end of study were included in the analysis. | Posted | Number | participants | 3 years |
|
3 months after randomization and then every 3 months for 3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selenium | Patients receive oral selenium once daily for 3 years |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI-other | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | SWOG Statistical Center | 206-667-4623 |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D012643 | Selenium |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
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| L-selenomethionine placebo | Drug | Randomization between active L-selenomethionine and placebo |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Age | Number | participants |
|
| Baseline Prostate-Specific Antigen (PSA) - reported by site | Number | participants |
|
Patients receive oral selenium once daily for 3 years |
| OG001 | Placebo | Patients receive oral placebo once daily for 3 years |
|
|
|
| Secondary | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. | Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included. | Posted | Number | Participants | 3 months after randomization and then every 3 months for 3 years |
|
|
|
| 9 |
| 203 |
| 54 |
| 203 |
| EG001 | Placebo | Patients receive oral placebo once daily for 3 years | 4 | 202 | 57 | 202 |
| Cardiovascular-other | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
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| LVEF decrease/CHF | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
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| Supraventricular arrhythmia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
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| Abdominal pain/cramping | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| GI-other | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Reportable adverse event, NOS | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Cerebrovascular ischemia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
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| Neuro-other | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Pleural effusions | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Thrombosis/embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
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| Fatigue/malaise/lethargy | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Rash/desquamation |
|
| Urinary frequency/urgency |
|