The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer

ISRCTN	ISRCTN20141297
DOI	https://doi.org/10.1186/ISRCTN20141297
ClinicalTrials.gov (NCT)	NCT00632983
Protocol serial number	HTA 96/20/99
Sponsor	University of Oxford (UK)
Funder	Health Technology Assessment Programme

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-treatment-approaches-for-prostate-cancer

Contact information

Prof F C Hamdy
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
Email	Freddie.hamdy@nds.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer
Study acronym	ProtecT
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/03/2027

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Male
Target sample size at registration	116500
Total final enrolment	8388
Key inclusion criteria	Men aged 50-69 years from the community, localised prostate cancer for eligibility for randomisation
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/10/2001
Date of final enrolment	20/01/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

John Radcliffe Hospital

Oxford
OX3 9DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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?
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
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
Other publications	case-control study	15/01/2012		Yes	No
Other publications	cross-sectional analysis	01/06/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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.