IMPACT study: Information Sheet for Men reaching 5 years of screening

Thank you for taking part in the IMPACT study. When you first joined the study we told you that we would like to offer you PSA screening for five years. You have now completed five years of screening and this information sheet has been written to tell you about what will happen next.

The study has been successfully recruiting men for over 5 years and has centres open in 14 countries around the world. We are aiming to recruit 1700 men in total, and based on current recruitment rates we estimate that we will reach our target by early 2013. We need to offer screening to all men for five years from enrolment and so the final study results will not be available until approximately 2018.

As you have now reached your fifth screen we would like to explain what will happen next.

Optional Biopsy

We are inviting all men who haven’t had a biopsy so far in the study to consider having a prostate biopsy after their fifth PSA screen. Your decision about whether to have a biopsy or not does not affect your participation in the study. Please read the separate Information Sheet about the biopsy to help you make a decision about whether you would like to have the biopsy or not.

Ongoing PSA testing

Until we have the final results of the study we will not be able to offer advice about the best way to screen for prostate cancer in men with BRCA1 or BRCA2 mutations. You will be sent a summary of the study findings once we have published the results. In the meantime please ask your local study team for their advice about whether you should have any ongoing PSA testing.

Future Contact

With your permission we would like to send you a one page questionnaire every year for the next 10 years to update us about any changes in the health of either you or your family. This should only take about 5-10 minutes to complete and will inform us about any important changes in your health.

We would like to take this opportunity to thank you for taking part in IMPACT!

PIS for men reaching 5 years of screening (centres not continuing screening: Version 1: 12/11/2010

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