Department of Urology
Sahlgrenska University Hospital
413 45 Gothenburg
Professor Jonas Hugosson
Department of Urology
University of Gotheburg
413 45 Gothenburg
The ethical committee of Gothenburg University approved the Gothenburg trial, i.e the Swedish section of the ERSPC, in 1994. The study started in January in 1995.
The protocol in Gothenburg has some differences compared to the other centers in the ERSPC. All men in the Gothenburg trial, are randomized up-front, it means before the informed consent. The screening population was randomised from the entire population of men born between January 1, 1930 and December 31, 1944, living in the community of Gothenburg January 1, 1995. Of these all together approximately 32,000 men, 10,000 were randomized to a control group and 10,000 to a screening group. 28 men in the screening group and 27 men in the control group were found to already have diagnosis of prostate cancer registered in the regional Cancer Registry. This is a very low incidence of prevalent prostate cancer and reflects the very low rate of opportunistic PSA-screening in the Swedish population at that time. It means that this study group is a population who previously has not been exposed to PSA-screening. Men in the screening arm have been invited every second year for PSA-testing until they turn 70. From the beginning a cut-off of level of 3 ng/mL has been used for further work-up. Men who have a PSA < 3 ng/mL are not further examined (no digital rectal examination is part of this screening program). Men with elevated PSA (=>3 ng/mL) are invited for an examination by an experienced urologist. This examination includes medical history, digital rectal examination, transrectal ultrasound and laterally directed sextant biopsies of the prostate. The last invitations in the study were sent out in 2014. Men in the youngest age cohort (born 1944) have been invited 10 times for PSA-testing, men born 1942-1943 have been invited 9 times, while the oldest age cohort (born 1930-1931) have been invited 3 times.
During the 20 years the study has been running there have been some minor changes in the protocol.
- The PSA cut off was lowered with 17 % in 1999. This adjustment was carried out in order to harmonize with other ERSPC-centres who used the Hybritech assay instead (in Gothenburg the Wallac assay has been used throughout the study). If calibrated to WHO standardization, the PSA cut off was lowered from 3.4 to 2.9 ng/mL.
- In 2005 a second lowering of the PSA cut off with 13 % was performed. This corresponds to a lowering from 2.9 to 2.5 ng/mL in WHO calibrated values.
- In the first and second screening round men with PSA => 7 ng/mL were reexamined after six months with a new PSA. If the still had an elevated value, they were invited for new DRE, TRUS and biopsies.
- All men with PSA <1 ng/mL in screening round 2, apart from those born 1930-1931 (who participated for the last time in round 3), were not invited in round 3. This step was carried out as results showed that no men who had PSA <1 ng/mL in the first screening round had PSA =>3 ng/mL in the second screening round.
- All men with PIN and ASAP were rebiopsied until round 5. From round 6 rebiopsies were only performed on men participating for the last time in the study.
- From round 8 the number of biopsy cores were changed from sextant biopsies to 10 template biopsies.
At the moment no further invitation take place. The study population is followed by annual linkage with the Cancer Registry as well as the Population Registry. In all men with prostate cancer important medical documentation is collected to define risk group at diagnosis and primary treatment. Furthermore, all men with prostate cancer are followed longitudinally from their medical case-books. Parametres such as time to progression and treatments are being recorded. Death certificates are collected in all deceased men and in those men with prostate cancer an independent Cause of Death Committee consisting of three members, assess the cause of death based on all available medical documentation.
Alltogether 7,655 men have participated at least once and 2,513 men have had at least one biopsy. A total of 1,051 men have been diagnosed with prostate cancer in the study.