Abstract
Objective
To investigate the functional and quality of life (QoL) outcomes of treatments for localised prostate cancer and inform treatment decision-making.
Patients and Methods
Men aged 50–69 years diagnosed with localised prostate cancer by prostate-specific antigen testing and biopsies at nine UK centres in the Prostate Testing for Cancer and Treatment (ProtecT) trial were randomised to, or chose one of, three treatments. Of 2565 participants, 1135 men received active monitoring (AM), 750 a radical prostatectomy (RP), 603 external-beam radiotherapy (EBRT) with concurrent androgen-deprivation therapy (ADT) and 77 low-dose-rate brachytherapy (BT, not a randomised treatment). Patient-reported outcome measures (PROMs) completed annually for 6 years were analysed by initial treatment and censored for subsequent treatments. Mixed effects models were adjusted for baseline characteristics using propensity scores.
Results
Treatment-received analyses revealed different impacts of treatments over 6 years. Men remaining on AM experienced gradual declines in sexual and urinary function with age (e.g., increases in erectile dysfunction from 35% of men at baseline to 53% at 6 years and nocturia similarly from 20% to 38%). Radical treatment impacts were immediate and continued over 6 years. After RP, 95% of men reported erectile dysfunction persisting for 85% at 6 years, and after EBRT this was reported by 69% and 74%, respectively (P < 0.001 compared with AM). After RP, 36% of men reported urinary leakage requiring at least 1 pad/day, persisting for 20% at 6 years, compared with no change in men receiving EBRT or AM (P < 0.001). Worse bowel function and bother (e.g., bloody stools 6% at 6 years and faecal incontinence 10%) was experienced by men after EBRT than after RP or AM (P < 0.001) with lesser effects after BT. No treatment affected mental or physical QoL.
Conclusion
Treatment decision-making for localised prostate cancer can be informed by these 6-year functional and QoL outcomes.
| Original language | English |
|---|---|
| Pages (from-to) | 370-380 |
| Number of pages | 11 |
| Journal | BJU International |
| Volume | 130 |
| Issue number | 3 |
| Early online date | 3 Apr 2022 |
| DOIs | |
| Publication status | Published - 23 Aug 2022 |
Bibliographical note
Funding Information:The study was supported by the NIHR Health Technology Assessment Programme (NIHR HTA: projects 96/20/06, 96/20/99, with University of Oxford as sponsor). Professor Lane is supported by the Bristol Randomised Trials Collaboration, a UKCRC registered Clinical Trials Unit (CTU) which, as part of the Bristol Trials Centre, is in receipt of NIHR CTU Support Funding. Professor Hamdy is supported by the Oxford NIHR Biomedical Research Centre Surgical Innovation and Evaluation Theme and Cancer Research UK Oxford Centre. Professors Blazeby, Lane and Martin and Dr Avery are supported by the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol (BRC‐1215‐200011).
Funding Information:
The study was supported by the NIHR Health Technology Assessment Programme (NIHR HTA: projects 96/20/06, 96/20/99, with University of Oxford as sponsor). Professor Lane is supported by the Bristol Randomised Trials Collaboration, a UKCRC registered Clinical Trials Unit (CTU) which, as part of the Bristol Trials Centre, is in receipt of NIHR CTU Support Funding. Professor Hamdy is supported by the Oxford NIHR Biomedical Research Centre Surgical Innovation and Evaluation Theme and Cancer Research UK Oxford Centre. Professors Blazeby, Lane and Martin and Dr Avery are supported by the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol (BRC-1215-200011). We thank all ProtecT participants and researchers, and members of the independent Trial Steering Committee, Data Monitoring Committee and Cause-of-death evaluation committee. Principal investigators: Freddie C. Hamdy (Chief Investigator), Jenny L. Donovan, David E. Neal. Trial co-ordinator: Janet Athene Lane. Trial statisticians: Chris Metcalfe, Tim J. Peters, Grace Young. Urologist leads: Prasad Bollina, Andrew Doble, Alan Doherty, Vincent Gnanapragasam, Owen Hughes, David Gillatt, Roger Kockelbergh, Howard Kynaston, Alan Paul, Edgar Paez, Philip Powell, Stephen Prescott, Derek Rosario, Edward Rowe. Others: John B. Anderson*, Jonathan Aning, James Catto, Garett Durkan, Anthony Kouparis, Hing Leung, Param Mariappan, Alan McNeill, Raj Persad, Hartwig Schwaibold, David Tulloch, Michael Wallace. Nurses leads: Susan Bonnington*, Lynne Bradshaw, Deborah Cooper, Emma Elliott, Phillipa Herbert, Peter Holding, Joanne Howson, Amanda Jones, Teresa Lennon, Norma Lyons, Hilary Moody, Claire Plumb, Tricia O'Sullivan, Elizabeth Salter, Pauline Thompson, Sarah Tidball, Jan Blaikie, Catherine Grey. Others: Tonia Adam, Sarah Askew, Sharon Atkinson, Tim Baynes, 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, 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, Ellie 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. Oncologists lead: Malcolm Mason. Others: Amit Bahl, Richard Benson, Mark Beresford, Catherine Ferguson, John Graham, Chris Herbert, Grahame Howard, Nick James, Peter Kirkbride, Alastair Law, Carmel Loughrey, Duncan McClaren, Helen Patterson*, Ian Pedley, Trevor Roberts*, Angus Robinson, Simon Russell, John Staffurth, Paul Symonds, Narottam Thanvi, Subramaniam Vasanthan, Paula Wilson. Histopathologists leads: Jon Oxley, Mary Robinson: Others: Selina Bhattarai, Neeta Deshmukh, John Dormer, Malee Fernando, John Goepel, David Griffiths, Ken Grigor, Nick Mayer, Murali Varma, Anne Warren. Radiologists and medical physics: 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, Pam Shuttleworth, Stephen Slade, Alasdair Steele, James Swinscoe, Marie Tiffany, John Townley, Jo Treeby, Michael Weston, Joyce Wilkinson, Lorraine Williams, Lucy Wills, Owain Woodley, Sue Yarrow. Other researchers and data managers: Lucy Brindle, Linda Davies, Michael Davis, Dan Dedman, Elizabeth Down, Hanan Khazragui, Richard M. Martin, Sian Noble, Hilary Taylor, Marta Tazewell, Emma L. Turner, Julia Wade, Eleanor Walsh, Grace Young. Administrative support: 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, Kathleen Parker, Christopher Pawsey, Michelle Purdie, Teresa Robson, Lynne Smith, Carole Stenton, Tom Steuart-Feilding, Beth Stott, Chris Sully, Caroline Sutton, Carol Torrington, Zoe Wilkins, Sharon Williams, Andrea Wilson, Ashleigh Weaver. Joint ProtecT and CAP cause of death committee: Richard M. Martin (Research Lead), Peter Albertsen (Chair), Jan Adolfsson, Amit Bahl, Michael Baum, Anthony Koupparis, Jon McFarlane, Jon Oxley, Colette Reid, Mary Robinson, Emma Turner, Anthony Zietman. Other researchers and data managers: Elizabeth Hill, Siaw Yein Ng, Naomi Williams, Jessica Toole, Charlotte Davies, Laura Hughes, Mari-Anne Rowlands, Lindsey Bell, Sean Harrison, and Jainee Mauree. Independent data monitoring committee Chairs: Adrian Grant* and Ian Roberts. Members: Deborah Ashby, Richard Cowan, Peter Fayers, Killian Mellon, James N'Dow, Tim O'Brien, Michael Sokhal. Trial steering committee: Michael Baum (Chair), Jan Adolfsson, Peter Albertsen, David Dearnaley, Fritz Schröder, Tracy Roberts, Anthony Zietman. *Deceased.
Publisher Copyright:
© 2022 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.
Keywords
- localised prostate cancer
- treatments
- Patient-reported outcome
- functional outcomes
- quality of life
- #PCSM
- #ProstateCancer
- #uroonc
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