Condition category
Cancer
Date applied
22/06/2010
Date assigned
29/06/2010
Last edited
13/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://media.erspc-media.org/sweden/

Contact information

Type

Scientific

Primary contact

Prof Jonas Hugosson

ORCID ID

Contact details

Bruna Stråket 11B
Göteborg
SE-41345
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

Prostate specific antigen (PSA) screening decreases prostate cancer mortality by 40% after 15 years.

Ethics approval

Ethical Review Committee at the University of Göteborg approved in 1994

Study design

Population-based randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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).

Secondary outcome measures

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.

Overall trial start date

01/01/1995

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Men born during 1930 through 1944 living in the city of Göteborg, Sweden

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

20,000 randomised

Participant 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

Recruitment start date

01/01/1995

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Sweden

Trial participating centre

Bruna Stråket 11B
Göteborg
SE-41345
Sweden

Sponsor information

Organisation

Sahlgrenska University Hospital (Sweden)

Sponsor details

Östra
Göteborg
SE-41345
Sweden

Sponsor type

Hospital/treatment centre

Website

http://www.sahlgrenska.se

Funders

Funder type

Research organisation

Funder name

Swedish Cancer Society (Sweden) (ref: 090107, 080315 and 083455)

Alternative name(s)

Swedish Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Funder name

Swedish Medical Research Council (Sweden) (ref: 20095)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Cancer Institute (USA) (ref: R21-CA127768-01A1)

Alternative name(s)

NCI

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15042673
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17643983
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20598634

Publication citations

  1. Results

    Hugosson J, Aus G, Lilja H, Lodding P, Pihl CG, Results of a randomized, population-based study of biennial screening using serum prostate-specific antigen measurement to detect prostate carcinoma., Cancer, 2004, 100, 7, 1397-1405, doi: 10.1002/cncr.20126.

  2. Results

    Carlsson S, Aus G, Wessman C, Hugosson J, Anxiety associated with prostate cancer screening with special reference to men with a positive screening test (elevated PSA) - Results from a prospective, population-based, randomised study., Eur. J. Cancer, 2007, 43, 14, 2109-2116, doi: 10.1016/j.ejca.2007.06.002.

  3. Results

    Hugosson J, Carlsson S, Aus G, Bergdahl S, Khatami A, Lodding P, Pihl CG, Stranne J, Holmberg E, Lilja H, Mortality results from the Göteborg randomised population-based prostate-cancer screening trial., Lancet Oncol., 2010, 11, 8, 725-732, doi: 10.1016/S1470-2045(10)70146-7.

Additional files

Editorial Notes