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S0000 Selenium and Vitamin E in Preventing Prostate Cancer (SELECT)

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00006392
First received: October 4, 2000
Last updated: October 23, 2015
Last verified: October 2015
Results First Received: June 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Prostate Cancer
Interventions: Drug: Vitamin E
Drug: Selenium
Other: Vitamin E placebo
Other: selenium placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Men were randomized at 427 study sites in the US, Puerto Rico and Canada between August 22, 2001 and June 24, 2004.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Vitamin E Vitamin E + matching placebo for selenium
Selenium Selenium + matching placebo for vitamin E
Combination Vitamin E + selenium
Placebo Matching placebo for vitamin E + matching placebo for selenium

Participant Flow:   Overall Study
    Vitamin E   Selenium   Combination   Placebo
STARTED   8904   8910   8863   8856 
COMPLETED   8737   8752   8703   8696 
NOT COMPLETED   167   158   160   160 
Ineligible                11                3                5                5 
Poor data/ppt mgmt, regulatory problems                156                155                155                155 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vitamin E Vitamin E + matching placebo for selenium
Selenium Selenium + matching placebo for vitamin E
Combination Vitamin E + selenium
Placebo Matching placebo for vitamin E + matching placebo for selenium
Total Total of all reporting groups

Baseline Measures
   Vitamin E   Selenium   Combination   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8737   8752   8703   8696   34888 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 62.4 
 (58.1 to 67.8) 
 62.6 
 (58.1 to 67.8) 
 62.3 
 (58.0 to 67.8) 
 62.6 
 (58.2 to 68.0) 
 62.3 
 (58.1 to 67.8) 
Gender 
[Units: Participants]
         
Female   0   0   0   0   0 
Male   8737   8752   8703   8696   34888 
Race/Ethnicity, Customized 
[Units: Participant]
         
White   6890   6942   6874   6863   27569 
African American   1107   1053   1076   1078   4314 
Hispanic (non-African American)   477   481   484   492   1934 
Hispanic (African American)   103   86   95   76   360 
Other   160   190   174   187   711 
Region of Enrollment 
[Units: Participants]
         
United States   7463   7471   7427   7428   29789 
Canada   909   915   911   904   3639 
Puerto Rico   365   366   365   364   1460 
Age (categorical) 
[Units: Participants]
         
50 - 54 years   402   337   385   355   1479 
55 - 64 years   5143   5076   5052   5078   20349 
65 - 74 years   2641   2733   2731   2702   10807 
>= 75 years   551   606   535   561   2253 
Education (highest) 
[Units: Participant]
         
<= High school graduate or GED   1875   1917   1898   1993   7683 
Some college/vocational school   2387   2327   2348   2291   9353 
>= College graduate   4394   4430   4372   4317   17513 
Unknown/missing   81   78   85   95   339 
PSA (ng/ml) 
[Units: Participant]
         
0.1 - 1.0   4208   4218   4213   4122   16761 
1.1 - 2.0   2653   2661   2666   2728   10708 
2.1 - 3.0   1228   1211   1149   1168   4756 
3.1 - 4.0   634   652   659   666   2611 
> 4.0   3   2   1   5   11 
Unknown/missing   11   8   15   7   41 
Smoking status 
[Units: Participant]
         
Never   3752   3780   3666   3682   14880 
Current   659   631   670   655   2615 
Former   4194   4214   4242   4208   16858 
Ever (unknown status)   55   61   56   63   235 
Unknown   77   66   69   88   300 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Prostate Cancer   [ Time Frame: Every six months for 7 to 12 years depending on when the participant was randomized. ]

2.  Secondary:   Number of Participants With Lung Cancer   [ Time Frame: 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. ]

3.  Secondary:   Number of Participants With Colorectal Cancer   [ Time Frame: 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. ]

4.  Secondary:   Number of Participants With Any Diagnosis of Cancer   [ Time Frame: 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. ]

5.  Secondary:   Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival   [ Time Frame: 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.  Secondary:   Number of Participants With Serious Cardiovascular Events   [ Time Frame: 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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 2066674623


Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00006392     History of Changes
Obsolete Identifiers: NCT00076128
Other Study ID Numbers: CDR0000068277
S0000 ( Other Identifier: SWOG )
U10CA037429 ( US NIH Grant/Contract Award Number )
Study First Received: October 4, 2000
Results First Received: June 12, 2012
Last Updated: October 23, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration