Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life

Athene Lane*, Chris Metcalfe, Grace J. Young, Tim J. Peters, Jane Blazeby, Kerry N L Avery, Daniel Dedman, Liz Down, Malcolm D. Mason, David E. Neal, Freddie C. Hamdy, Jenny L. Donovan, Sue Bonnington, Lynne Bradshaw, Debbie Cooper, Emma Elliott, Pippa Herbert, Peter Holding, Joanne Howson, Mandy JonesTeresa Lennon, Norma Lyons, Hilary Moody, Claire Plumb, Tricia O'Sullivan, Liz Salter, Sarah Tidball, Pauline Thompson, Tonia Adam, Sarah Askew, Sharon Atkinson, Tim Baynes, Jan Blaikie, Carole Brain, Viv Breen, Sarah Brunt, Sean Bryne, Jo Bythem, Jenny Clarke, Jenny Cloete, Susan Dark, Gill Davis, Rachael De La Rue, Jane Denizot, Elspeth Dewhurst, Anna Dimes, Nicola Dixon, Penny Ebbs, Ingrid Emmerson, Jill Ferguson, Ali Gadd, Lisa Geoghegan, Alison Grant, Collette Grant, Catherine Gray, Rosemary Godfrey, Louise Goodwin, Susie Hall, Liz Hart, Andrew Harvey, Chloe Hoult, Sarah Hawkins, Sharon Holling, Alastair Innes, Sue Kilner, Fiona Marshall, Louise Mellen, Andrea Moore, Sally Napier, Julie Needham, Kevin Pearse, Anna Pisa, Mark Rees, Elliw Richards, Lindsay Robson, Janet Roxburgh, Nikki Samuel, Irene Sharkey, Michael Slater, Donna Smith, Pippa Taggart, Helen Taylor, Vicky Taylor, Ayesha Thomas, Briony Tomkies, Nicola Trewick, Claire Ward, Christy Walker, Ayesha Williams, Colin Woodhouse, Elizabeth Wyber, Jonathan Aning, Prasad Bollina, Jim Catto, Andrew Doble, Alan Doherty, Garett Durkan, David Gillatt, Owen Hughes, Roger Kocklebergh, Anthony Kouparis, Howard Kynaston, Hing Leung, Param Mariappan, Alan McNeill, Edgar Paez, Alan Paul, Raj Persad, Philip Powell, Stephen Prescott, Derek Rosario, Edward Rowe, Hartwig Schwaibold, David Tulloch, Mike Wallace, Amit Bahl, Richard Benson, Mark Beresford, Catherine Ferguson, John Graham, Chris Herbert, Grahame Howard, Nick James, Alastair Law, Carmel Loughrey, Duncan McClaren, Helen Patterson, Ian Pedley, Angus Robinson, Simon Russell, John Staffurth, Paul Symonds, Narottam Thanvi, Subramaniam Vasanthan, Paula Wilson, Helen Appleby, Dominic Ash, Dean Aston, Steven Bolton, Graham Chalmers, John Conway, Nick Early, Tony Geater, Lynda Goddall, Claire Heymann, Deborah Hicks, Liza Jones, Susan Lamb, Geoff Lambert, Gill Lawrence, Geraint Lewis, John Lilley, Aileen MacLeod, Pauline Massey, Alison McQueen, Rollo Moore, Lynda Penketh, Janet Potterton, Neil Roberts, Helen Showler, Stephen Slade, Alasdair Steele, James Swinscoe, Marie Tiffany, John Townley, Jo Treeby, Joyce Wilkinson, Lorraine Williams, Lucy Wills, Owain Woodley, Sue Yarrow, Selina Bhattarai, Neeta Deshmukh, John Dormer, Malee Fernando, John Goepel, David Griffiths, Ken Grigor, Nick Mayer, Jon Oxley, Mary Robinson, Murali Varma, Anne Warren, Lucy Brindle, Michael Davis, Hanan Khazragui, Sian Noble, Hilary Taylor, Marta Tazewell, Emma Turner, Julia Wade, Eleanor Walsh, Susan Baker, Elizabeth Bellis-Sheldon, Chantal Bougard, Joanne Bowtell, Catherine Brewer, Chris Burton, Jennie Charlton, Nicholas Christoforou, Rebecca Clark, Susan Coull, Christine Croker, Rosemary Currer, Claire Daisey, Gill Delaney, Rose Donohue, Jane Drew, Rebecca Farmer, Susan Fry, Jean Haddow, Alex Hale, Susan Halpin, Belle Harris, Barbara Hattrick, Sharon Holmes, Helen Hunt, Vicky Jackson, Donna Johnson, Mandy Le Butt, Jo Leworthy, Tanya Liddiatt, Alex Martin, Jainee Mauree, Susan Moore, Gill Moulam, Jackie Mutch, Alena Nash, Kathleen Parker, Christopher Pawsey, Michelle Purdie, Teresa Robson, Lynne Smith, Jo Snoeck, Carole Stenton, Tom Steuart-Feilding, Chris Sully, Caroline Sutton, Carol Torrington, Zoe Wilkins, Sharon Williams, Andrea Wilson, Adrian Grant, Ian Roberts, Deborah Ashby, Richard Cowan, Peter Fayers, Killian Mellon, James N'Dow, Tim O'Brien, ProtecT Study Group

*Corresponding author for this work

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Objectives: To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations. 

Materials and Methods: A total of 1643 randomized men, aged 50–69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999–2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures. 

Results: A total of 1438 participants completed biopsy questionnaires (88%) and 77–88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65–70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49–54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments. 

Conclusion: The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.

Original languageEnglish
Pages (from-to)869-879
Number of pages11
JournalBJU international
Issue number6
Publication statusPublished - 1 Dec 2016

Bibliographical note

Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.


  • functional status
  • ISRCTN 20141297
  • prostate cancer
  • protect trial
  • quality of life
  • treatment


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