Extract

Background and study aims Prostate cancer is a leading cause of cancer death among men in the Western world. A PSA test looks for raised levels of PSA in the blood that may be a sign of prostate cancer in its early stages. Although PSA screening has been shown to prevent deaths, it can also lead to over-diagnosis (diagnosis of disease that would not have caused symptoms or death) and performing unnecessary biopsies (where a sample of the prostate is taken for diagnosis). The aim of this study is to assess whether a new biomarker test for prostate cancer can reduce how many men are referred to biopsy whilst still detecting high-risk prostate cancer. The study will also assess whether the new test decreases the number of low-risk prostate cancers diagnosed and improves the quality and effectiveness of prostate cancer diagnosis in routine health care in Stockholm. Who can participate? Men aged 50 to 69 living in Stockholm County Council or Region Gotland who have not previously been diagnosed with prostate cancer What does the study involve? Participants are randomly allocated to one of two groups. One group are referred to biopsy based on the PSA test result only. The other group are referred to biopsy based on their age, their genes, their family history and biomarkers. What are the possible benefits and risks of participating? There are no benefits for the participants other than a free prostate cancer test. There is a low risk of over-diagnosis of low-risk cancers. Where is the study run from? Karolinska Institutet (Sweden) When is the study starting and how long is it expected to run for? January 2013 to December 2014 Who is funding the study? Stockholm County Council (Sweden) Who is the main contact? Prof. Henrik Grönberg

Inclusion criteria

• Prostate cancer

Links

• ictrp
• isrctn