The Göteborg randomised population based prostate cancer screening trial
| ISRCTN | ISRCTN54449243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54449243 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Bruna Stråket 11B
Göteborg
SE-41345
Sweden
Study information
| Study design | Population-based randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/01/1995 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 20,000 randomised |
| 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
SE-41345
Sweden
Sponsor information
Sahlgrenska University Hospital (Sweden)
Hospital/treatment centre
Hospital/treatment centre
Östra
Göteborg
SE-41345
Sweden
| Website | http://www.sahlgrenska.se |
|---|---|
"ROR" |
https://ror.org/04vgqjj36 |
Funders
Funder type
Research organisation
Swedish Cancer Society (Sweden) (ref: 090107, 080315 and 083455)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
Swedish Medical Research Council (Sweden) (ref: 20095)
No information available
National Cancer Institute (USA) (ref: R21-CA127768-01A1)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituto Nacional del Cáncer, National Cancer Institute at the National Institutes of Health, Instituto Nacional del Cáncer de los Institutos Nacionales de la Salud, NCI
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
