Prostate Cancer Active Surveillance Trigger trial (PCASTt)

Active surveillance (AS) is recommended in many guidelines to reduce overtreatment in prostate cancer. However, there is no consensus in important areas.

We therefore started a randomized multicenter trial titled Prostate Cancer Active Surveillance Trigger trial (PCASTt/SPCG-17) in 2016. The study randomise between current practise and standardized triggers (ST) for repeat biopsies and curative treatment. Magnetic resonance imaging (MRI) is used as a follow-up tool.

We aim to answer the following questions;Who to include; Can men with low-risk and favourable intermediate-risk prostate cancer be followed-up in AS with ST?How to follow-up patients; Can MRI in addition to PSA density be used as a safe follow-up method in AS with ST?When to do repeat biopsies; Can ST reduce unnecessary biopsies?

When to start curative treatment; Will ST for curative treatment reduce overtreatment without increasing disease progression and prostate cancer mortality?We have included 1570 out of the planned 2000 men at 22 centers in Sweden, Norway, Finland, Denmark and the United Kingdom.

The first main analysis of the primary endpoint - disease progression - and secondary endpoints will be published one year after all 2000 men has been included.Significance: This is the only large randomized active surveillance trial in the world, it will change the lives for an innumberable number of men with prostate cancer and make AS an evidence-based and safe option to immediate curative treatment.