1. SELECT: Selenium and Vitamin E Prostate Cancer Prevention Trial
National Participant Advisory Board, 2006

2. SELECT is funded by grants from the National Cancer Institute and the National Center for Complementary and Alternative Medicine. SELECT is managed by the Southwest Oncology Group (SWOG).

3. Rationale for SELECT
The selenium and vitamin E Study Supplements were chosen based on secondary results for prostate cancer from other randomized controlled trials.

4. SELECT Study Supplements
Selenium: 200 micrograms per day from L-selenomethionine or matched placebo
Vitamin E: 400 International Units per day all rac-α-tocopheryl acetate or matched placebo
Participants were asked to take 2 capsules every day.
Neither the participants nor the researchers knew what the participant was taking.
Participants were randomly assigned to receive:
Selenium and vitamin E
Selenium and a placebo
Vitamin E and a placebo
Two placebos
The placebos contained inactive ingredients.

5. Follow-Up Schedule
SELECT registered the first participant in August 2001.
Participants are seen twice a year.
Participants diagnosed with prostate cancer are seen once a year.
At each annual visit, a limited physical exam is conducted which includes blood pressure, weight, and smoking status.

6. Study Transition
On September 15, 2008, the independent SELECT Data and Safety Monitoring Committee met and made the recommendation to discontinue study supplementation and for study leadership to consider post-supplementation follow-up.
The study leadership met and accepted this decision.
Work was begun to notify the investigators and participants and train the staff on obtaining any remaining Study Supplement bottles and responding to participant questions.

7. So what can we tell you now?
The first few slides of data we are about to share with you is baseline information gathered at the time participants joined the trial.

8. What are the ages of the participants?
Age in years :
50 – 54 = 1,479
55 – 64 = 20,349
65 – 74 = 10,807
75+ = ,253
Total = 34,888
These are the ages of the participants at the time they received their first bottles of Study Supplements.
A participant who was 50 when he joined in SELECT in 2001, would be 58 today. 8

9. What are the race and ethnicity of the participants?
Race and ethnicity data is based on self-report by the participant. SELECT recruited the largest percentage of black participants ever randomized to a cancer prevention trial. 9

10. What was the smoking history of the participants?

11. What is the education level of the participants?11

12. There were 31,685 participants alive and without prostate cancer when the Study Supplements were stopped. At that time, how many of these participants were taking one or both of the Study Supplements?
Answer: 24,508 (77%) were taking one or both Study Supplements
The data on this slide and in the next few slides are from the SELECT paper published in the December 2008 on-line version in the Journal of the American Medical Association. This same paper was published in the hard copy of JAMA in January 2009.

13. How many participants were diagnosed with prostate cancer?
Answer: 1,758
416 were taking the placebo
473 were taking vitamin E
432 were taking selenium
437 were taking both vitamin E and selenium
The number of participants with prostate cancer are fairly evenly distributed between arms with a slight increase in those taking only vitamin E, thus why this finding was not statistically significant but had to be reported as a ‘slight increase.’

14. How many participants are deceased?
Answer: 1,477
476 died of cancer (only 1 died of prostate cancer)
507 died due cardiovascular disease
494 died due to other causes
This is based on data from the JAMA publication in December 2008.

15. How many participants were diagnosed with diabetes?
Answer: 2,753
669 were taking placebo
700 were taking vitamin E
724 were taking selenium
660 were taking both vitamin E and selenium
As you can see, there is a slight increase of self reported diabetes in those participants taking selenium but very little difference in those taking placebo or both selenium and vitamin E. Thus, why this was not considered statistically significant.

16. Ancillary Studies Continue
PREADVISE – Alzheimer’s Disease
SEE – Cataracts and Age-Related Macular Degeneration
RAS – Chronic Obstructive Pulmonary Disease (COPD)
ACP – Colorectal Polyps
Site staff: Describe the number of participants at your Site or Center participating in these ancillary studies. RAS was being done in specifically chosen sites and is no longer accepting new participants. ACP is the newest ancillary study.

17. Conclusion
Research has definitively demonstrated that, in these doses and formulations, selenium, vitamin E, and selenium plus vitamin E do not prevent prostate cancer in the generally healthy population of men in SELECT.

18. Where are we now?

19. You are being asked to …..
Stop your Study Supplements and return all bottles to your study site.
Continue your visits to your study site.
Continue to update your contact information so the study site staff can stay in touch with you.
Notify your study site if there are any major changes in your health.

20. Know your options for finding out which Study Supplements you were taking.
All participants will be told at the end of SELECT.
You can talk to your personal physician to find out if it is necessary for you to know what you were taking.
Knowing what you were taking shouldn’t change how a physician treats you.

21. IMPORTANT
Data from the participants remaining blinded (unaware of which Study Supplements you were taking) until after follow-up will provide the most reliable information on how to assess prostate cancer, adult onset diabetes and other diseases of male aging.
Staff: read or share the Study Transition Fact Sheet for Participants.

22. Stay Informed!
Read CHOICE – The Newsletter for SELECT Men which is available from your study site twice each year.
Continue to check the SELECT public website at
Read the Questions and Answers on SELECT at
Watch for articles written by the SELECT Study Investigators.
These articles are listed on the public website
Check out scientific journals at the local library or at their on-line websites

23. Thanks to all SELECT participants who can take pride in knowing they continue to make major contributions to science and the future for men’s health.
Thanks to all the spouses, family members, friends and physicians who support the participants on SELECT.

24. Thanks to you SELECT Continues!