Men with a genetic predisposition to prostate cancer

Why is this study being conducted?

Prostate cancer is a significant public health problem. In the EU approximately 200,000 men are diagnosed annually with prostate cancer. There are 24,000 cases per year in England and Wales and 10,000 deaths. The incidence is increasing, even when screen-detected cancers are considered, and within the next few years it will become the most common cancer in UK men.

This study is an international targeted prostate screening study of men at increased prostate cancer risk due to the presence of known pathogenic mutations in BRCA1 and BRCA2 genes.

There are only approximately 150 men with a known BRCA1 or BRCA2 mutation in the UK. Research has shown that these men are at an increased risk of developing prostate cancer but more information is needed about the pathogenesis of prostate cancer in this defined group and the role of screening in these men. The study will offer annual PSA screening to these men to determine the incidence of prostate cancer in this group. The study will also look at new markers of early prostate cancer in this cohort.

What are the main eligibility criteria?

Inclusion Criteria:

• Male carriers of a known pathogenic BRCA1/2 mutations or men testing negative for a known BRCA1/2 mutation in their family
• Aged between 40-69 years old
• No previous history of prostate cancer

Exclusion Criteria:

Patients will be excluded from the study if they:

• Previous cancer with terminal prognosis of less than 5 years
• Previous prostate cancer

Important

If you are interested in participating in a clinical trial, please register and you will be contacted by the study coordinator or person involved with the specific trial you are interested in.

• Prior to your participation a physician will inform you about the process in detail and examine if you are eligible to take part in the study.
• If you are to participate all medication will be free.
• Of course you can terminate during the process any time.

References:

Trial information was taken from the following sites:

• http://clinicaltrials.gov/ct2/show/NCT00261456
• In ClinLife opinion the main facts were taken and centralized. ClinLife isn´t liable for defects or wrong translation.
• Official Title: The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer: Targeted Screening in BRCA1/2 Mutation Carriers & Controls