The “Göteborg-2 trial”; A prospective, randomized, population-based trial of prostate cancer screening with PSA testing followed by MRI of the prostate.

This is a continued application of the Göteborg 1 and 2 prostate cancer (PC) screening trials.

The main aim is to develop a better screening algorithm that improves the ratio of harms to benefits (mainly by decreasing the current high risk of over-diagnosis).

The hypothesis is that including MRI in the algorithm and biopsy only men with positive MRI will reduce the risk of detecting clinically insignificant PC by 50 % but still maintain a high(er) detection rate of clinically significant PC.

The Göteborg-2 trial started in 2015 and is designed to randomize 54,000 men in ages 50-60.99-years in the Göteborg area.

Of those, 18,000 men will not be invited (controls) while 36,000 men will be invited regularly until they reach the upper age limit.

Men accepting invitation are further randomized into 3 arms; one control arm where all men with elevated PSA have 12 standard blind systematic biopsies (not MRI directed), while in arm 2 (PSA cut off 3 ng/mL) and arm 3 (PSA cut off 1.8 ng/mL), only men with positive MRI are biopsied and only directed towards the MRI lesion.

This is a long-term study from which the most important results will be achieved 5-10-years ahead. However, the first main endpoint report based on round one will be submitted during 2020.

The study is unique, until recently, no other ongoing study worldwide aimed at testing this concept and our study results may be the last brick needed to defend introduction of population-based PC screening.