| ID | Type | Description | Link |
|---|---|---|---|
| S0000 | Other Identifier | SWOG | |
| U10CA037429 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Eastern Cooperative Oncology Group | NETWORK |
| Cancer and Leukemia Group B | NETWORK |
| NCIC Clinical Trials Group |
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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
OBJECTIVES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin E + selenium placebo | Experimental | vitamin E and selenium placebo daily for 7-12 years |
|
| Selenium + vitamin E placebo | Experimental | selenium and vitamin E placebo daily for 7-12 years |
|
| Vitamin E + selenium | Experimental | vitamin E and selenium placebo daily for 7-12 years |
|
| Vitamin E placebo + selenium placebo | Placebo Comparator | vitamine E placebo and selenium placebo daily for 7-12 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin E | Drug | 400 IU daily by mouth for 7-12 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Prostate Cancer | Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. | Every six months for 7 to 12 years depending on when the participant was randomized. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Lung Cancer | Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized. |
Not provided
DISEASE CHARACTERISTICS:
Healthy male volunteers
Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry
Total prostate-specific antigen ≤ 4.0 ng/mL within 364 days prior to study entry
No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial neoplasia
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 7 years since prior randomization to SWOG-9217, with completion of end-of-study biopsy requirement
No additional concurrent selenium or vitamin E (contained in individual supplements, antioxidant mix, or multivitamin)
Concurrent multivitamins allowed (supplied on study)
No concurrent anticoagulation therapy (e.g., warfarin)
Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day) allowed
Concurrent anti-hypertension medication allowed
No concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only)
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| Name | Affiliation | Role |
|---|---|---|
| Eric Klein, MD | The Cleveland Clinic | Study Chair |
| Philip J. Walther, MD, PhD | Duke University | Study Chair |
| Laurence H. Klotz, MD | Toronto Sunnybrook Regional Cancer Centre | Study Chair |
| Scott M. Lippman, M.D. | MD Anderson | Study Chair |
| Ian M. Thompson, M.D. | University of Texas | Study Chair |
| J. Michael Gaziano, M.D. | MAVERIC | Study Chair |
| Daniel D Karp, M.D. | Beth Israel Deaconess | Study Chair |
| Fadlo R. Khuri, M.D. | MD Anderson | Study Chair |
| Michael M Lieber, M.D. | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11552710 | Background | Hoque A, Albanes D, Lippman SM, Spitz MR, Taylor PR, Klein EA, Thompson IM, Goodman P, Stanford JL, Crowley JJ, Coltman CA, Santella RM. Molecular epidemiologic studies within the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Cancer Causes Control. 2001 Sep;12(7):627-33. doi: 10.1023/a:1011277600059. | |
| 19373601 | Background | El-Bayoumy K. The negative results of the SELECT study do not necessarily discredit the selenium-cancer prevention hypothesis. Nutr Cancer. 2009;61(3):285-6. doi: 10.1080/01635580902892829. No abstract available. |
Not provided
Not provided
Prior to randomization, there was a three month formal pre-randomization period with no placebo run-in capsules to give potential participants to decide if they would agree to stop disallowed over-the-counter supplements of selenium or vitamin E. By returning for randomization, they exhibited their willingness to adhere to the trial.
Men were randomized at 427 study sites in the US, Puerto Rico and Canada between August 22, 2001 and June 24, 2004.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin E | Vitamin E + matching placebo for selenium |
| FG001 | Selenium | Selenium + matching placebo for vitamin E |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| NETWORK |
Not provided
Not provided
Not provided
Not provided
| Selenium | Drug | 200 mcg daily for 7-12 years |
|
|
| Vitamin E placebo | Other | daily for 7-12 years |
|
|
| selenium placebo | Other | daily for 7-12 years |
|
|
| Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. |
| Number of Participants With Colorectal Cancer | Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized. | Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. |
| Number of Participants With Any Diagnosis of Cancer | Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized. | Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. |
| Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival | Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized. | Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. |
| Number of Participants With Serious Cardiovascular Events | Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized. | Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. |
| Midwest Center for Hematology/Oncology |
| Joliet |
| Illinois |
| 60432 |
| United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Good Samaritan Hospital Cancer Treatment Center | Cincinnati | Ohio | 45220 | United States |
| Bethesda North Hospital | Cincinnati | Ohio | 45242 | United States |
| Tod Children's Hospital | Youngstown | Ohio | 44501 | United States |
| LaFortune Cancer Center at St. John Medical Center | Tulsa | Oklahoma | 74104 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-0001 | United States |
| Geisinger Medical Group - Scenery Park | State College | Pennsylvania | 16801 | United States |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| U.T. Cancer Institute at University of Tennessee Medical Center | Knoxville | Tennessee | 37920-6999 | United States |
| 16315648 | Background | Cook ED, Moody-Thomas S, Anderson KB, Campbell R, Hamilton SJ, Harrington JM, Lippman SM, Minasian LM, Paskett ED, Craine S, Arnold KB, Probstfield JL. Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Clin Trials. 2005;2(5):436-42. doi: 10.1191/1740774505cn111oa. |
| 15767358 | Background | Kristal AR, King IB, Albanes D, Pollak MN, Stanzyk FZ, Santella RM, Hoque A. Centralized blood processing for the selenium and vitamin E cancer prevention trial: effects of delayed processing on carotenoids, tocopherols, insulin-like growth factor-I, insulin-like growth factor binding protein 3, steroid hormones, and lymphocyte viability. Cancer Epidemiol Biomarkers Prev. 2005 Mar;14(3):727-30. doi: 10.1158/1055-9965.EPI-04-0596. |
| 15657339 | Background | Lippman SM, Goodman PJ, Klein EA, Parnes HL, Thompson IM Jr, Kristal AR, Santella RM, Probstfield JL, Moinpour CM, Albanes D, Taylor PR, Minasian LM, Hoque A, Thomas SM, Crowley JJ, Gaziano JM, Stanford JL, Cook ED, Fleshner NE, Lieber MM, Walther PJ, Khuri FR, Karp DD, Schwartz GG, Ford LG, Coltman CA Jr. Designing the Selenium and Vitamin E Cancer Prevention Trial (SELECT). J Natl Cancer Inst. 2005 Jan 19;97(2):94-102. doi: 10.1093/jnci/dji009. |
| 19066370 | Result | Lippman SM, Klein EA, Goodman PJ, Lucia MS, Thompson IM, Ford LG, Parnes HL, Minasian LM, Gaziano JM, Hartline JA, Parsons JK, Bearden JD 3rd, Crawford ED, Goodman GE, Claudio J, Winquist E, Cook ED, Karp DD, Walther P, Lieber MM, Kristal AR, Darke AK, Arnold KB, Ganz PA, Santella RM, Albanes D, Taylor PR, Probstfield JL, Jagpal TJ, Crowley JJ, Meyskens FL Jr, Baker LH, Coltman CA Jr. Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2009 Jan 7;301(1):39-51. doi: 10.1001/jama.2008.864. Epub 2008 Dec 9. |
| 21990298 | Result | Klein EA, Thompson IM Jr, Tangen CM, Crowley JJ, Lucia MS, Goodman PJ, Minasian LM, Ford LG, Parnes HL, Gaziano JM, Karp DD, Lieber MM, Walther PJ, Klotz L, Parsons JK, Chin JL, Darke AK, Lippman SM, Goodman GE, Meyskens FL Jr, Baker LH. Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2011 Oct 12;306(14):1549-56. doi: 10.1001/jama.2011.1437. |
| 27998216 | Derived | Tangen CM, Goodman PJ, Till C, Schenk JM, Lucia MS, Thompson IM Jr. Biases in Recommendations for and Acceptance of Prostate Biopsy Significantly Affect Assessment of Prostate Cancer Risk Factors: Results From Two Large Randomized Clinical Trials. J Clin Oncol. 2016 Dec 20;34(36):4338-4344. doi: 10.1200/JCO.2016.68.1965. Epub 2016 Oct 28. |
| 27519183 | Derived | Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9. |
| 27197287 | Derived | Chan JM, Darke AK, Penney KL, Tangen CM, Goodman PJ, Lee GM, Sun T, Peisch S, Tinianow AM, Rae JM, Klein EA, Thompson IM Jr, Kantoff PW, Mucci LA. Selenium- or Vitamin E-Related Gene Variants, Interaction with Supplementation, and Risk of High-Grade Prostate Cancer in SELECT. Cancer Epidemiol Biomarkers Prev. 2016 Jul;25(7):1050-1058. doi: 10.1158/1055-9965.EPI-16-0104. Epub 2016 May 6. |
| 23171483 | Derived | Abner EL, Dennis BC, Mathews MJ, Mendiondo MS, Caban-Holt A, Kryscio RJ, Schmitt FA; PREADViSE Investigators; Crowley JJ; SELECT Investigators. Practice effects in a longitudinal, multi-center Alzheimer's disease prevention clinical trial. Trials. 2012 Nov 20;13:217. doi: 10.1186/1745-6215-13-217. |
| 23064404 | Derived | Goodman PJ, Hartline JA, Tangen CM, Crowley JJ, Minasian LM, Klein EA, Cook ED, Darke AK, Arnold KB, Anderson K, Yee M, Meyskens FL, Baker LH. Moving a randomized clinical trial into an observational cohort. Clin Trials. 2013 Feb;10(1):131-42. doi: 10.1177/1740774512460345. Epub 2012 Oct 12. |
| 20833684 | Derived | Chlebowski RT, Menon R, Chaisanguanthum RM, Jackson DM. Prospective evaluation of two recruitment strategies for a randomized controlled cancer prevention trial. Clin Trials. 2010 Dec;7(6):744-8. doi: 10.1177/1740774510383886. Epub 2010 Sep 10. |
| 20156960 | Derived | Cook ED, Arnold KB, Hermos JA, McCaskill-Stevens W, Moody-Thomas S, Probstfield JL, Hamilton SJ, Campbell RD, Anderson KB, Minasian LM. Impact of supplemental site grants to increase African American accrual for the Selenium and Vitamin E Cancer Prevention Trial. Clin Trials. 2010 Feb;7(1):90-9. doi: 10.1177/1740774509357227. |
| FG002 |
| Combination |
Vitamin E + selenium |
| FG003 | Placebo | Matching placebo for vitamin E + matching placebo for selenium |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin E | Vitamin E + matching placebo for selenium |
| BG001 | Selenium | Selenium + matching placebo for vitamin E |
| BG002 | Combination | Vitamin E + selenium |
| BG003 | Placebo | Matching placebo for vitamin E + matching placebo for selenium |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participant |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Age (categorical) | Number | participants |
| ||||||||||||||||
| Education (highest) | Number | Participant |
| ||||||||||||||||
| PSA (ng/ml) | Number | Participant |
| ||||||||||||||||
| Smoking status | Number | Participant |
|
| 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 | Number of Participants With Prostate Cancer | Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. | All randomized eligible men not at 2 sites for which the DSMC said the data could not be used due to participant and data management issues as well as regulatory problems. | Posted | Number | participants | Every six months for 7 to 12 years depending on when the participant was randomized. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Lung Cancer | Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized. | All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. | Posted | Number | participants | Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Colorectal Cancer | Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized. | All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. | Posted | Number | participants | Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Diagnosis of Cancer | Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized. | All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. | Posted | Number | participants | Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival | Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized. | All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. Deaths include those reported as SAEs as well as non-SAE deaths as this was a prevention trial with older generally healthy men at baseline who were followed for a long time. | Posted | Number | participants | Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Cardiovascular Events | Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized. | All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. | Posted | Number | participants | Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. |
|
6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selenium Alone | Selenium + placebo for vitamin E | 96 | 8,752 | 2,605 | 8,752 | ||
| EG001 | Combination | Selenium + vitamin E | 93 | 8,702 | 2,550 | 8,702 | ||
| EG002 | Placebo | Placebo for selenium + placebo for vitamin E | 108 | 8,696 | 2,421 | 8,696 | ||
| EG003 | Vitamin E Alone | Vitamin E + placebo for selenium | 99 | 8,737 | 2,553 | 8,737 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia, NOS | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiovascular-other | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Conduction abnormality/block | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| LVEF decrease/CHF | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Supraventricular arrhythmia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Eye-other | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vision,NOS | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Melena/ GI bleeding | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rectal bleeding/hematochezia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constitutional symptoms-other | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemorrhage w/o 3-4 thrombocyt | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Reportable adverse event, NOS | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Liver-clinical | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Liver-other | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Respiratory infect w/o neutrop | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Respiratory infection, unk ANC | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary tr infect w/o neutrop | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Surgery-hemorrhage | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia/arthralgia, NOS | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Second primary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | Systematic Assessment |
| |
| CNS hemorrhage | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cerebrovascular ischemia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cranial neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuro-other | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Seizures | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Erectile impotence | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
| |
| ARDS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Emphysema/COPD | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Aortic Stenosis | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiomyopathy | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Carotid stenosis | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Peripheral arterial ischemia | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Halitosis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue/malaise/lethargy | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | SWOG Statistical Center | 2066674623 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D024502 | alpha-Tocopherol |
| D012643 | Selenium |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D024505 | Tocopherols |
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
Not provided
Not provided
| Male |
|
| African American |
|
| Hispanic (non-African American) |
|
| Hispanic (African American) |
|
| Other |
|
| Canada |
|
| Puerto Rico |
|
| 55 - 64 years |
|
| 65 - 74 years |
|
| >= 75 years |
|
| Some college/vocational school |
|
| >= College graduate |
|
| Unknown/missing |
|
| 1.1 - 2.0 |
|
| 2.1 - 3.0 |
|
| 3.1 - 4.0 |
|
| > 4.0 |
|
| Unknown/missing |
|
| Current |
|
| Former |
|
| Ever (unknown status) |
|
| Unknown |
|
Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo. |
| Regression, Cox |
| < .01 |
The p-value was adjusted for multiple comparisons. |
| Hazard Ratio (HR) |
| 1.04 |
| 2-Sided |
| 99 |
| 0.87 |
| 1.24 |
| No |
| Superiority or Other |
| Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 99% power to detect a 44% reduction in prostate cancer for combination vs. Placebo. | Regression, Cox | < .01 | The p-value was adjusted for multiple comparisons. | Hazard Ratio (HR) | 1.05 | 99 | .88 | 1.25 | No | Superiority or Other |
Matching placebo for vitamin E + matching placebo for selenium |
|
|
|
Matching placebo for vitamin E + matching placebo for selenium |
|
|
|
Matching placebo for vitamin E + matching placebo for selenium |
|
|
|
| OG002 | Combination | Vitamin E + selenium |
| OG003 | Placebo | Matching placebo for vitamin E + matching placebo for selenium |
|
|
|
Matching placebo for vitamin E + matching placebo for selenium
|
|
|