European Randomised study of Screening for Prostate Cancer
| ISRCTN | ISRCTN49127736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49127736 |
| Secondary identifying numbers | NTR156 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 12/04/2016
- 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
Mrs M. Roobol
Scientific
Scientific
Erasmus Medical Center
Department of Urology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 4634548 |
|---|---|
| m.roobol@erasmusmc.nl |
Study information
| Study design | Multicentre randomised active-controlled parallel-group 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 | European Randomised study of Screening for Prostate Cancer |
| Study acronym | ERSPC |
| Study objectives | Screening causes a difference in prostate cancer mortality of 20% or more. |
| Ethics approval(s) | Local medical ethics committee gave approval |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | Prostate Specific Antigen (PSA) determination followed by Digital Rectal Examination (DRE) and prostate biopsy if PSA greater than or equal to 3. |
| Intervention type | Other |
| Primary outcome measure | Prostate cancer mortality compared between the screened and the non-screened group of men at risk. |
| Secondary outcome measures | 1. Progression-free (tumour free) survival 2. Survival free of metastatic disease 3. Quality of life in the screened and non-screened populations |
| Overall study start date | 01/10/1991 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Male |
| Target number of participants | 251133 |
| Key inclusion criteria | Males aged 55 - 74 years (including age 74) |
| Key exclusion criteria | Previous diagnosis of prostate cancer |
| Date of first enrolment | 01/10/1991 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Belgium
- Finland
- France
- Italy
- Netherlands
- Spain
- Sweden
- Switzerland
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
University/education
University/education
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
No information available
European Union (EU) (Belgium) - Fifth and Sixth Framework Programmes (FP5, FP6)
No information available
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)
No information available
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 | 26/03/2009 | Yes | No | |
| Results article | results | 01/08/2011 | Yes | No | |
| Other publications | 11-year follow-up | 15/03/2012 | Yes | No | |
| Results article | results | 01/05/2012 | Yes | No | |
| Results article | results | 01/11/2012 | Yes | No | |
| Results article | results | 01/02/2014 | Yes | No | |
| Other publications | 13-year follow-up | 06/12/2014 | Yes | No | |
| Results article | results | 01/08/2015 | Yes | No |
Editorial Notes
12/04/2016: Publication reference added.
