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

This study is ongoing, but not recruiting participants.
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 5, 2012
Last verified: October 2012
History of Changes
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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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  
Number of Participants  
[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
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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. ]
  Show Outcome Measure 1

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. ]
  Show Outcome Measure 2

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. ]
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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. ]
  Show Outcome Measure 4

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. ]
  Show Outcome Measure 5

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. ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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.  


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:


Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00006392     History of Changes
Obsolete Identifiers: NCT00076128
Other Study ID Numbers: CDR0000068277, S0000, U10CA037429
Study First Received: October 4, 2000
Results First Received: June 12, 2012
Last Updated: October 5, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration