European Randomised study of Screening for Prostate Cancer
| ISRCTN | ISRCTN49127736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49127736 |
| Protocol serial number | NTR156 |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Funders | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), European Union (EU) (Belgium) - Fifth and Sixth Framework Programmes (FP5, FP6), The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 30/10/2025
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised active-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Prostate cancer mortality compared between the screened and the non-screened group of men at risk. |
| Key secondary outcome measure(s) |
1. Progression-free (tumour free) survival |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Male |
| Target sample size at registration | 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
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 | 26/03/2009 | Yes | No | |
| Results article | results | 01/08/2011 | 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 | |
| Results article | results | 01/08/2015 | Yes | No | |
| Results article | European Study of Prostate Cancer Screening - 23-Year Follow-up | 30/10/2025 | 30/10/2025 | Yes | No |
| Other publications | 11-year follow-up | 15/03/2012 | Yes | No | |
| Other publications | 13-year follow-up | 06/12/2014 | 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 |
Editorial Notes
30/10/2025: Publication reference added.
12/04/2016: Publication reference added.
