The Göteborg2 study; A prospective randomized, population-based prostate cancer screening study with PSA followed by MRI of the prostate

The aim of this project is to develop novel and improved screening algorithms for prostate cancer (PC). The project is motivated by two reasons. First, PC is the most common cause of cancer death among Swedish men.

Second, early detection is possible by using the blood test PSA but PSA screening is associated with a huge risk of over-diagnosis meaning that half of all men detected would never develop symptoms.The main project in this application is the Göteborg 2 prostate cancer screening trial which was launched in 2015.

This is the largest ongoing screening study world wide with 57,000 men randomized of which one third was randomized to a future control group and two thirds are invited to screening. Those accepting the invitation are further randomized into 3 groups.

The first group is the reference group in which all men with a PSA≥ 3 ng/mL had a MRI but irrespective of MRI result they also have systematic biopsies of the prostate.

Experimental group 2 also have a PSA cut off at 3 ng/mL for MRI but in this group only men with suspicious lesions at MRI are biopsied and only with targeted biopsies. Experimental group 3 is identical with group 2 but the PSA cut off is 1.8 ng/mL. The main endpoint is the rate of insignificant PC in each arm (defined as ISUP grade 1 in biopsies).

The first end-point analysis was published in NEJM 2022 showed a 54 % decrease in insignificant PC. The most important analysis are still ahead analyzing the results of repeated screening.