Contact information

Type

Scientific

Primary contact

Prof F C Hamdy

ORCID ID

Contact details

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
Freddie.hamdy@nds.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00632983

Protocol/serial number

HTA 96/20/99

Study information

Scientific title

Acronym

ProtecT

Study hypothesis

Current 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: http://www.hta.ac.uk/1230

On 11/01/2008 the anticipated end date of this trial has been updated from 1 June 2006 to 31 December 2013.

On 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 below have been updated accordingly.

On 27/09/2010 the anticipated end date of this trial has been updated from 31 December 2013 to 31 December 2015. At this time, two primary outcome measures were added (see relevant field).

On 14/08/2013 the target number of participants was changed from 230,000 to 116,500

Ethics approval

Trent Multicentre Research Ethics Committee (Trent MREC), approved on 21/06/2001 (ref: 01/4/025)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.bris.ac.uk/social-community-medicine/projects/protect/

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.controlled-trials.com/ISRCTN08435261 and details of ISRCTN92187251: The CAP (Comparison Arm for ProtecT) study on http://www.controlled-trials.com/ISRCTN92187251

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Primary outcome measures as of 14/08/2013:

1. Disease-specific survival at 10 years

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

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

Added 14/08/2013:

1. Overall survival
2. Disease progression (biochemical and clinical)
3. Lower urinary tract symptoms
4. Psychosocial imapct of cancer diagnosis and treatment including generic health status, quality of life and sexual function
5. Cost-effectiveness of the treatments

Overall trial start date

01/06/2001

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Men aged 50-69 years from the community, localised prostate cancer for eligibility for randomisation

Participant type

Patient

Age group

Senior

Gender

Male

Target number of participants

116,500

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/06/2001

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor of Surgery and Urology
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Faculty of Medical Science
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16978272
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18006969
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20372151
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21047592
5. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20473853
6. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20652394
7. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20976066
8. 2012 case-control study in http://www.ncbi.nlm.nih.gov/pubmed/22106399
9. 2012 cross-sectional analysis in http://www.ncbi.nlm.nih.gov/pubmed/22527168
10. 2012 active surveillance results in http://www.ncbi.nlm.nih.gov/pubmed/22859401
11. 2012 acceptability results in http://www.ncbi.nlm.nih.gov/pubmed/23271772
12. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23085814
13. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25163905

Publication citations

  1. Results

    Brindle LA, Oliver SE, Dedman D, Donovan JL, Neal DE, Hamdy FC, Lane JA, Peters TJ, Measuring the psychosocial impact of population-based prostate-specific antigen testing for prostate cancer in the UK., BJU Int., 2006, 98, 4, 777-782, doi: 10.1111/j.1464-410X.2006.06401.x.

  2. Results

    Lane JA, Howson J, Donovan JL, Goepel JR, Dedman DJ, Down L, Turner EL, Neal DE, Hamdy FC, Detection of prostate cancer in unselected young men: prospective cohort nested within a randomised controlled trial., BMJ, 2007, 335, 7630, 1139, doi: 10.1136/bmj.39381.436829.BE.

  3. Results

    Macefield RC, Metcalfe C, Lane JA, Donovan JL, Avery KN, Blazeby JM, Down L, Neal DE, Hamdy FC, Vedhara K, , Impact of prostate cancer testing: an evaluation of the emotional consequences of a negative biopsy result., Br. J. Cancer, 2010, 102, 9, 1335-1340, doi: 10.1038/sj.bjc.6605648.

  4. Results

    Lane JA, Hamdy FC, Martin RM, Turner EL, Neal DE, Donovan JL, Latest results from the UK trials evaluating prostate cancer screening and treatment: the CAP and ProtecT studies., Eur. J. Cancer, 2010, 46, 17, 3095-3101, doi: 10.1016/j.ejca.2010.09.016.

  5. Results

    Turner EL, Lane JA, Donovan JL, Davis MJ, Metcalfe C, Neal DE, Hamdy FC, Martin RM, Association of diabetes mellitus with prostate cancer: nested case-control study (Prostate testing for cancer and treatment study)., Int. J. Cancer, 2011, 128, 2, 440-446, doi: 10.1002/ijc.25360.

  6. Results

    Rowlands MA, Holly JM, Gunnell D, Gilbert R, Donovan J, Lane JA, Marsden G, Collin SM, Hamdy F, Neal DE, Martin RM, The relation between adiposity throughout the life course and variation in IGFs and IGFBPs: evidence from the ProtecT (Prostate testing for cancer and Treatment) study., Cancer Causes Control, 2010, 21, 11, 1829-1842, doi: 10.1007/s10552-010-9610-x.

  7. Results

    Lewis SJ, Murad A, Chen L, Davey Smith G, Donovan J, Palmer T, Hamdy F, Neal D, Lane JA, Davis M, Cox A, Martin RM, Associations between an obesity related genetic variant (FTO rs9939609) and prostate cancer risk., PLoS ONE, 2010, 5, 10, e13485, doi: 10.1371/journal.pone.0013485.

  8. Active surveillance results

    Burton AJ, Martin RM, Donovan JL, Lane JA, Davis M, Hamdy FC, Neal DE, Tilling K, Associations of lifestyle factors and anthropometric measures with repeat PSA levels during active surveillance/monitoring., Cancer Epidemiol. Biomarkers Prev., 2012, 21, 10, 1877-1885, doi: 10.1158/1055-9965.EPI-12-0411.

  9. Acceptability results

    Donovan JL, Presenting treatment options to men with clinically localized prostate cancer: the acceptability of active surveillance/monitoring., J. Natl. Cancer Inst. Monographs, 2012, 2012, 45, 191-196, doi: 10.1093/jncimonographs/lgs030.

  10. Results

    Rowlands MA, Tilling K, Holly JM, Metcalfe C, Gunnell D, Lane A, Davis M, Donovan J, Hamdy F, Neal DE, Martin RM, Insulin-like growth factors (IGFs) and IGF-binding proteins in active monitoring of localized prostate cancer: a population-based observational study., Cancer Causes Control, 2013, 24, 1, 39-45, doi: 10.1007/s10552-012-0087-7.

  11. Results

    Lane JA, Donovan JL, Davis M, Walsh E, Dedman D, Down L, Turner EL, Mason MD, Metcalfe C, Peters TJ, Neal DE, Hamdy FC, , Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial., Lancet Oncol., 2014, 15, 10, 1109-1118, doi: 10.1016/S1470-2045(14)70361-4.

  12. Rowlands MA, Holly JM, Gunnell D, Donovan J, Lane JA, Hamdy F, Neal DE, Oliver S, Smith GD, Martin RM, Circulating insulin-like growth factors and IGF-binding proteins in PSA-detected prostate cancer: the large case-control study ProtecT., Cancer Res., 2012, 72, 2, 503-515, doi: 10.1158/0008-5472.CAN-11-1601.

  13. Young NJ, Metcalfe C, Gunnell D, Rowlands MA, Lane JA, Gilbert R, Avery KN, Davis M, Neal DE, Hamdy FC, Donovan J, Martin RM, Holly JM, A cross-sectional analysis of the association between diet and insulin-like growth factor (IGF)-I, IGF-II, IGF-binding protein (IGFBP)-2, and IGFBP-3 in men in the United Kingdom., Cancer Causes Control, 2012, 23, 6, 907-917, doi: 10.1007/s10552-012-9961-6.

Editorial Notes