The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer
| ISRCTN | ISRCTN20141297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20141297 |
| ClinicalTrials.gov number | NCT00632983 |
| Secondary identifying numbers | HTA 96/20/99 |
- Submission date
- 14/10/2002
- Registration date
- 14/10/2002
- Last edited
- 10/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Contact information
Scientific
Professor of Surgery and Urology
Head of Nuffield Department of Surgical Sciences
Faculty of Medical Science
University of Oxford
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0003-2627-2154 |
|---|---|
| Freddie.hamdy@nds.ox.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: https://www.bristol.ac.uk/population-health-sciences/projects/protect/ |
| Scientific title | The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer |
| Study acronym | ProtecT |
| Study hypothesis | Current hypothesis as of 18/03/2019: The overall aim is to evaluate the effectiveness, cost-effectiveness and acceptability of treatments for men with localised prostate cancer within the context of a pragmatic randomised controlled trial. This will compare three treatments (active monitoring, radical prostatectomy and radical radiotherapy). Specific objectives are as follows: 1. To assess survival at 15 years following treatment. 2. To investigate a number of medium-term outcomes, including: disease progression (biochemical and clinical), treatment complications, lower urinary tract symptoms, psychosocial impact of treatment, including generic health status, quality of life and sexual function. Previous hypothesis as of 14/08/2013: The overall aim is to evaluate the effectiveness, cost-effectiveness and acceptability of treatments for men with localised prostate cancer within the context of a pragmatic randomised controlled trial. This will compare three treatments (active monitoring, radical prostatectomy and radical radiotherapy). Specific objectives are as follows: 1. To assess survival at 10 years and 15 years following treatment 2. To investigate a number of short and medium-term outcomes, including: disease progression (biochemical and clinical), treatment complications, lower urinary tract symptoms, psychosocial impact of case-finding and treatment, including generic health status, quality of life and sexual function 3. To estimate the resource use and costs of case-finding, treatment and follow-up, and to compare costs and outcomes of treatment in terms of survival and health related quality of life. Previous hypothesis: The overall aim is to evaluate the effectiveness, cost-effectiveness and acceptability of treatments for men with localised prostate cancer within the context of a pragmatic randomised controlled trial. This will compare 3 treatments (active monitoring, radical prostatectomy and radical radiotherapy). Specific objectives are as follows: 1. To assess survival at 5, 10 years and 15 years following treatment 2. To investigate a number of short and medium-term outcomes, including: disease progression (biochemical and clinical), treatment complications, lower urinary tract symptoms, psychosocial impact of case-finding and treatment, including generic health status, quality of life and sexual function 3. To estimate the resource use and costs of case-finding, treatment and follow-up, and to compare costs and outcomes of treatment in terms of survival and health related quality of life. Details of this study can also be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/962099/#/ Protocol can be found at: https://njl-admin.nihr.ac.uk/document/download/2007358 |
| Ethics approval(s) | Trent Multicentre Research Ethics Committee (Trent MREC), 21/06/2001, ref: 01/4/025 |
| Condition | Prostate cancer |
| Intervention | Current interventions as of 14/08/2013: 1. Radical prostatectomy 2. Radical radiotherapy 3. Active monitoring: monitoring of the disease including prostate specific antigen levels Previous interventions: 1. Radical prostatectomy 2. Radical radiotherapy 3. Active monitoring of prostate specific antigen (PSA) levels See details of ISRCTN08435261: ProtecT feasibility on http://www.isrctn.com/ISRCTN08435261 and details of ISRCTN92187251: The CAP (Comparison Arm for ProtecT) study on http://www.isrctn.com/ISRCTN92187251 |
| Intervention type | Mixed |
| Primary outcome measure | Current primary outcome measures as of 18/03/2019: 1. Disease-specific survival at 15 years. 2. Disease progression (biochemical and clinical). 3. Treatment complications (long term). 4. Lower urinary tract symptoms. 5. Psychosocial impact of treatment including generic health status, quality of life and sexual function. 6. Prostate cancer specific survival. 7. Overall survival. Previous primary outcome measures as of 14/08/2013: 1. Disease-specific survival at 10 years Previous primary outcome measures as of 27/09/2010: 1. Disease progression (biochemical and clinical) 2. Treatment complications 3. Lower urinary tract symptoms 4. Psychosocial impact of case-finding and treatment including generic health status, quality of life and sexual function 5. Prostate cancer specific survival 6. Overall survival Previous primary outcome measures as of 14/10/2002: 1. Disease progression (biochemical and clinical) 2. Treatment complications 3. Lower urinary tract symptoms 4. Psychosocial impact of case-finding and treatment including generic health status, quality of life and sexual function |
| Secondary outcome measures | Current secondary outcome measures as of 21/07/2021: 1. Overall survival 2. Disease progression (biochemical and clinical) 3. Lower urinary tract symptoms 4. Psychosocial impact of cancer diagnosis and treatment including generic health status, quality of life and sexual function 5. Cost-effectiveness of the treatments 15 year median analysis no health economic analysis Previous secondary outcome measures added 14/08/2013: 1. Overall survival 2. Disease progression (biochemical and clinical) 3. Lower urinary tract symptoms 4. Psychosocial impact of cancer diagnosis and treatment including generic health status, quality of life and sexual function 5. Cost-effectiveness of the treatments |
| Overall study start date | 01/06/2001 |
| Overall study end date | 31/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Male |
| Target number of participants | 116,500 |
| Total final enrolment | 8388 |
| Participant inclusion criteria | Men aged 50-69 years from the community, localised prostate cancer for eligibility for randomisation |
| Participant exclusion criteria | Not provided at time of registration. |
| Recruitment start date | 01/10/2001 |
| Recruitment end date | 20/01/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
OX3 9DU
United Kingdom
Sponsor information
University/education
Faculty of Medical Science
John Radcliffe Hospital
Oxford
OX3 9DU
England
United Kingdom
| Website | http://www.ox.ac.uk |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Freddie C Hamdy (freddie.hamdy@nds.ox.ac.uk), anonymised data, 2023 indefinitely, request via a standard proforma to the ProtecT PIs to consider requests and can give the web link. consent was obtained |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/10/2006 | Yes | No | |
| Results article | results | 01/12/2007 | Yes | No | |
| Results article | results | 27/04/2010 | Yes | No | |
| Results article | results | 19/10/2010 | Yes | No | |
| Results article | results | 01/11/2010 | Yes | No | |
| Results article | results | 01/11/2010 | Yes | No | |
| Results article | results | 15/01/2011 | Yes | No | |
| Other publications | case-control study | 15/01/2012 | Yes | No | |
| Other publications | cross-sectional analysis | 01/06/2012 | Yes | No | |
| Results article | active surveillance results | 01/10/2012 | Yes | No | |
| Results article | acceptability results | 01/12/2012 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No | |
| Results article | results | 01/09/2014 | Yes | No | |
| Results article | results | 01/02/2015 | Yes | No | |
| Results article | results | 18/09/2015 | Yes | No | |
| Results article | results | 13/10/2016 | Yes | No | |
| Results article | results | 13/10/2016 | Yes | No | |
| Results article | results | 01/08/2017 | Yes | No | |
| Results article | results | 01/04/2018 | 12/09/2019 | Yes | No |
| Results article | results | 01/09/2019 | 26/05/2020 | Yes | No |
| Results article | results | 01/09/2020 | 17/07/2020 | Yes | No |
| Results article | 10 year results | 01/08/2020 | 13/08/2020 | Yes | No |
| Results article | embedded qualitative study results | 09/09/2020 | 11/09/2020 | Yes | No |
| Results article | 15 year results | 11/03/2023 | 14/03/2023 | Yes | No |
Editorial Notes
10/05/2023: Internal review.
14/03/2023: Publication reference added.
07/11/2022: The following changes were made to the trial record:
1. The overall trial end date has been changed from 31/03/2022 to 31/03/2027.
2. The intention to publish date has been changed from 31/05/2022 to 31/12/2022.
11/02/2022: The following changes have been made:
1. The overall trial end date has been changed from 28/02/2022 to 31/03/2022.
2. The intention to publish date has been changed from 01/03/2022 to 31/05/2022.
3. The individual participant data (IPD) sharing statement has been added.
21/07/2021: The following changes have been made:
1. The secondary outcome measures have been updated.
2. The IPD sharing statement has been added.
30/06/2021: The following changes have been made:
1. The overall trial end date has been changed from 30/06/2021 to 28/02/2022.
2. The intention to publish date has been added.
3. The participant information sheet has been changed from http://www.bris.ac.uk/social-community-medicine/projects/protect/ to https://www.bristol.ac.uk/population-health-sciences/projects/protect/.
4. Cancer Research UK lay results summary link added to Results (plain English).
11/09/2020: Publication reference added.
13/08/2020: Publication reference added.
17/07/2020: Publication reference added.
26/05/2020: Publication reference added.
12/09/2019: Publication reference and total final enrolment added.
18/03/2019: The following changes were made:
1. The ORCID was added.
2. The study hypothesis was updated.
3. The primary outcome measures were updated.
4. The overall trial end date was changed from 31/12/2015 to 30/06/2021.
27/06/2017: Publication reference added.
11/01/2017: Publication references added.
14/08/2013: The target number of participants was changed from 230,000 to 116,500.
27/09/2010: The overall trial end date was changed from 31/12/2013 to 31/12/2015.
28/04/2010: The Principal Investigator of this trial has moved from the University of Sheffield to the University of Oxford. The sponsor and contact details have been updated accordingly.
11/01/2008: The overall trial end date was changed from 01/06/2006 to 31/12/2013.
