The Göteborg randomised population based prostate cancer screening trial

ISRCTN	ISRCTN54449243
DOI	https://doi.org/10.1186/ISRCTN54449243
Protocol serial number	N/A
Sponsor	Sahlgrenska University Hospital (Sweden)
Funders	Swedish Cancer Society (Sweden) (ref: 090107, 080315 and 083455), Swedish Medical Research Council (Sweden) (ref: 20095), National Cancer Institute (USA) (ref: R21-CA127768-01A1)

Submission date: 22/06/2010
Registration date: 29/06/2010
Last edited: 13/09/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jonas Hugosson
Scientific

Bruna Stråket 11B
Göteborg
SE-41345
Sweden

Study information

Primary study design	Interventional
Study design	Population-based randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The Göteborg prostate cancer screening trial: a population-based randomised controlled trial of a screening group invited for biennial prostate specific antigen (PSA) testing versus a control group not invited
Study objectives	Prostate specific antigen (PSA) screening decreases prostate cancer mortality by 40% after 15 years.
Ethics approval(s)	Ethical Review Committee at the University of Göteborg approved in 1994
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	Men allocated to the screening arm are invited every second year for PSA testing, until they reach the upper age limit (70 years). Only men with PSA at or above the threshold (greater than or equal to 3 ng/mL) are invited for further urological work-up including digital rectal examination (DRE), transrectal ultrasound (TRUS) examination, and laterally directed sextant biopsies. Men allocated to the control group will not be part of any planned intervention; the incidence of prostate cancer, stage, grade and primary treatment as well as cause of death will be registered in the control group. Last invitaion to the study will be in 2014 but follow-up will continue for many more years. Last follow-up is not stated in the protocol as things may change during a 20-year study.
Intervention type	Other
Primary outcome measure(s)	Prostate cancer specific mortality (absolute and relative risk reduction in cumulative prostate cancer mortality) analysed according to the intention-to-screen principle (comparing the screening group with the control group). Analysed at study completion (after 15 years).
Key secondary outcome measure(s)	1. Cumulative prostate cancer incidence and the proportion of screening attendees 2. Comparisons of stage and age distribution 3. Lead and length time bias 4. Quality of life between screened men and controls Analysed at study completion.
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	20000
Key inclusion criteria	Men born during 1930 through 1944 living in the city of Göteborg, Sweden
Key exclusion criteria	1. Men with a prior diagnosis of prostate cancer 2. Men who had died or emigrated but had not been removed from the Population Register at time of randomisation
Date of first enrolment	01/01/1995
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

Sweden

Study participating centre

Bruna Stråket 11B

Göteborg
SE-41345
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2004		Yes	No
Results article	results	01/09/2007		Yes	No
Results article	results	01/08/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes