Abstract
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 language | English |
|---|---|
| Pages (from-to) | 869-879 |
| Number of pages | 11 |
| Journal | BJU international |
| Volume | 118 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 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.Keywords
- functional status
- ISRCTN 20141297
- prostate cancer
- protect trial
- quality of life
- treatment
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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. / Lane, Athene; Metcalfe, Chris; Young, Grace J.; Peters, Tim J.; Blazeby, Jane; Avery, Kerry N L; Dedman, Daniel; Down, Liz; Mason, Malcolm D.; Neal, David E.; Hamdy, Freddie C.; Donovan, Jenny L.; Bonnington, Sue; Bradshaw, Lynne; Cooper, Debbie; Elliott, Emma; Herbert, Pippa; Holding, Peter; Howson, Joanne; Jones, Mandy; Lennon, Teresa; Lyons, Norma; Moody, Hilary; Plumb, Claire; O'Sullivan, Tricia; Salter, Liz; Tidball, Sarah; Thompson, Pauline; Adam, Tonia; Askew, Sarah; Atkinson, Sharon; Baynes, Tim; Blaikie, Jan; Brain, Carole; Breen, Viv; Brunt, Sarah; Bryne, Sean; Bythem, Jo; Clarke, Jenny; Cloete, Jenny; Dark, Susan; Davis, Gill; De La Rue, Rachael; Denizot, Jane; Dewhurst, Elspeth; Dimes, Anna; Dixon, Nicola; Ebbs, Penny; Emmerson, Ingrid; Ferguson, Jill; Gadd, Ali; Geoghegan, Lisa; Grant, Alison; Grant, Collette; Gray, Catherine; Godfrey, Rosemary; Goodwin, Louise; Hall, Susie; Hart, Liz; Harvey, Andrew; Hoult, Chloe; Hawkins, Sarah; Holling, Sharon; Innes, Alastair; Kilner, Sue; Marshall, Fiona; Mellen, Louise; Moore, Andrea; Napier, Sally; Needham, Julie; Pearse, Kevin; Pisa, Anna; Rees, Mark; Richards, Elliw; Robson, Lindsay; Roxburgh, Janet; Samuel, Nikki; Sharkey, Irene; Slater, Michael; Smith, Donna; Taggart, Pippa; Taylor, Helen; Taylor, Vicky; Thomas, Ayesha; Tomkies, Briony; Trewick, Nicola; Ward, Claire; Walker, Christy; Williams, Ayesha; Woodhouse, Colin; Wyber, Elizabeth; Aning, Jonathan; Bollina, Prasad; Catto, Jim; Doble, Andrew; Doherty, Alan; Durkan, Garett; Gillatt, David; Hughes, Owen; Kocklebergh, Roger; Kouparis, Anthony; Kynaston, Howard; Leung, Hing; Mariappan, Param; McNeill, Alan; Paez, Edgar; Paul, Alan; Persad, Raj; Powell, Philip; Prescott, Stephen; Rosario, Derek; Rowe, Edward; Schwaibold, Hartwig; Tulloch, David; Wallace, Mike; Bahl, Amit; Benson, Richard; Beresford, Mark; Ferguson, Catherine; Graham, John; Herbert, Chris; Howard, Grahame; James, Nick; Law, Alastair; Loughrey, Carmel; McClaren, Duncan; Patterson, Helen; Pedley, Ian; Robinson, Angus; Russell, Simon; Staffurth, John; Symonds, Paul; Thanvi, Narottam; Vasanthan, Subramaniam; Wilson, Paula; Appleby, Helen; Ash, Dominic; Aston, Dean; Bolton, Steven; Chalmers, Graham; Conway, John; Early, Nick; Geater, Tony; Goddall, Lynda; Heymann, Claire; Hicks, Deborah; Jones, Liza; Lamb, Susan; Lambert, Geoff; Lawrence, Gill; Lewis, Geraint; Lilley, John; MacLeod, Aileen; Massey, Pauline; McQueen, Alison; Moore, Rollo; Penketh, Lynda; Potterton, Janet; Roberts, Neil; Showler, Helen; Slade, Stephen; Steele, Alasdair; Swinscoe, James; Tiffany, Marie; Townley, John; Treeby, Jo; Wilkinson, Joyce; Williams, Lorraine; Wills, Lucy; Woodley, Owain; Yarrow, Sue; Bhattarai, Selina; Deshmukh, Neeta; Dormer, John; Fernando, Malee; Goepel, John; Griffiths, David; Grigor, Ken; Mayer, Nick; Oxley, Jon; Robinson, Mary; Varma, Murali; Warren, Anne; Brindle, Lucy; Davis, Michael; Khazragui, Hanan; Noble, Sian; Taylor, Hilary; Tazewell, Marta; Turner, Emma; Wade, Julia; Walsh, Eleanor; Baker, Susan; Bellis-Sheldon, Elizabeth; Bougard, Chantal; Bowtell, Joanne; Brewer, Catherine; Burton, Chris; Charlton, Jennie; Christoforou, Nicholas; Clark, Rebecca; Coull, Susan; Croker, Christine; Currer, Rosemary; Daisey, Claire; Delaney, Gill; Donohue, Rose; Drew, Jane; Farmer, Rebecca; Fry, Susan; Haddow, Jean; Hale, Alex; Halpin, Susan; Harris, Belle; Hattrick, Barbara; Holmes, Sharon; Hunt, Helen; Jackson, Vicky; Johnson, Donna; Le Butt, Mandy; Leworthy, Jo; Liddiatt, Tanya; Martin, Alex; Mauree, Jainee; Moore, Susan; Moulam, Gill; Mutch, Jackie; Nash, Alena; Parker, Kathleen; Pawsey, Christopher; Purdie, Michelle; Robson, Teresa; Smith, Lynne; Snoeck, Jo; Stenton, Carole; Steuart-Feilding, Tom; Sully, Chris; Sutton, Caroline; Torrington, Carol; Wilkins, Zoe; Williams, Sharon; Wilson, Andrea; Grant, Adrian; Roberts, Ian; Ashby, Deborah; Cowan, Richard; Fayers, Peter; Mellon, Killian; N'Dow, James; O'Brien, Tim; ProtecT Study Group.
In: BJU international, Vol. 118, No. 6, 01.12.2016, p. 869-879.Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments
T2 - study design, and baseline urinary, bowel and sexual function and quality of life
AU - Lane, Athene
AU - Metcalfe, Chris
AU - Young, Grace J.
AU - Peters, Tim J.
AU - Blazeby, Jane
AU - Avery, Kerry N L
AU - Dedman, Daniel
AU - Down, Liz
AU - Mason, Malcolm D.
AU - Neal, David E.
AU - Hamdy, Freddie C.
AU - Donovan, Jenny L.
AU - Bonnington, Sue
AU - Bradshaw, Lynne
AU - Cooper, Debbie
AU - Elliott, Emma
AU - Herbert, Pippa
AU - Holding, Peter
AU - Howson, Joanne
AU - Jones, Mandy
AU - Lennon, Teresa
AU - Lyons, Norma
AU - Moody, Hilary
AU - Plumb, Claire
AU - O'Sullivan, Tricia
AU - Salter, Liz
AU - Tidball, Sarah
AU - Thompson, Pauline
AU - Adam, Tonia
AU - Askew, Sarah
AU - Atkinson, Sharon
AU - Baynes, Tim
AU - Blaikie, Jan
AU - Brain, Carole
AU - Breen, Viv
AU - Brunt, Sarah
AU - Bryne, Sean
AU - Bythem, Jo
AU - Clarke, Jenny
AU - Cloete, Jenny
AU - Dark, Susan
AU - Davis, Gill
AU - De La Rue, Rachael
AU - Denizot, Jane
AU - Dewhurst, Elspeth
AU - Dimes, Anna
AU - Dixon, Nicola
AU - Ebbs, Penny
AU - Emmerson, Ingrid
AU - Ferguson, Jill
AU - Gadd, Ali
AU - Geoghegan, Lisa
AU - Grant, Alison
AU - Grant, Collette
AU - Gray, Catherine
AU - Godfrey, Rosemary
AU - Goodwin, Louise
AU - Hall, Susie
AU - Hart, Liz
AU - Harvey, Andrew
AU - Hoult, Chloe
AU - Hawkins, Sarah
AU - Holling, Sharon
AU - Innes, Alastair
AU - Kilner, Sue
AU - Marshall, Fiona
AU - Mellen, Louise
AU - Moore, Andrea
AU - Napier, Sally
AU - Needham, Julie
AU - Pearse, Kevin
AU - Pisa, Anna
AU - Rees, Mark
AU - Richards, Elliw
AU - Robson, Lindsay
AU - Roxburgh, Janet
AU - Samuel, Nikki
AU - Sharkey, Irene
AU - Slater, Michael
AU - Smith, Donna
AU - Taggart, Pippa
AU - Taylor, Helen
AU - Taylor, Vicky
AU - Thomas, Ayesha
AU - Tomkies, Briony
AU - Trewick, Nicola
AU - Ward, Claire
AU - Walker, Christy
AU - Williams, Ayesha
AU - Woodhouse, Colin
AU - Wyber, Elizabeth
AU - Aning, Jonathan
AU - Bollina, Prasad
AU - Catto, Jim
AU - Doble, Andrew
AU - Doherty, Alan
AU - Durkan, Garett
AU - Gillatt, David
AU - Hughes, Owen
AU - Kocklebergh, Roger
AU - Kouparis, Anthony
AU - Kynaston, Howard
AU - Leung, Hing
AU - Mariappan, Param
AU - McNeill, Alan
AU - Paez, Edgar
AU - Paul, Alan
AU - Persad, Raj
AU - Powell, Philip
AU - Prescott, Stephen
AU - Rosario, Derek
AU - Rowe, Edward
AU - Schwaibold, Hartwig
AU - Tulloch, David
AU - Wallace, Mike
AU - Bahl, Amit
AU - Benson, Richard
AU - Beresford, Mark
AU - Ferguson, Catherine
AU - Graham, John
AU - Herbert, Chris
AU - Howard, Grahame
AU - James, Nick
AU - Law, Alastair
AU - Loughrey, Carmel
AU - McClaren, Duncan
AU - Patterson, Helen
AU - Pedley, Ian
AU - Robinson, Angus
AU - Russell, Simon
AU - Staffurth, John
AU - Symonds, Paul
AU - Thanvi, Narottam
AU - Vasanthan, Subramaniam
AU - Wilson, Paula
AU - Appleby, Helen
AU - Ash, Dominic
AU - Aston, Dean
AU - Bolton, Steven
AU - Chalmers, Graham
AU - Conway, John
AU - Early, Nick
AU - Geater, Tony
AU - Goddall, Lynda
AU - Heymann, Claire
AU - Hicks, Deborah
AU - Jones, Liza
AU - Lamb, Susan
AU - Lambert, Geoff
AU - Lawrence, Gill
AU - Lewis, Geraint
AU - Lilley, John
AU - MacLeod, Aileen
AU - Massey, Pauline
AU - McQueen, Alison
AU - Moore, Rollo
AU - Penketh, Lynda
AU - Potterton, Janet
AU - Roberts, Neil
AU - Showler, Helen
AU - Slade, Stephen
AU - Steele, Alasdair
AU - Swinscoe, James
AU - Tiffany, Marie
AU - Townley, John
AU - Treeby, Jo
AU - Wilkinson, Joyce
AU - Williams, Lorraine
AU - Wills, Lucy
AU - Woodley, Owain
AU - Yarrow, Sue
AU - Bhattarai, Selina
AU - Deshmukh, Neeta
AU - Dormer, John
AU - Fernando, Malee
AU - Goepel, John
AU - Griffiths, David
AU - Grigor, Ken
AU - Mayer, Nick
AU - Oxley, Jon
AU - Robinson, Mary
AU - Varma, Murali
AU - Warren, Anne
AU - Brindle, Lucy
AU - Davis, Michael
AU - Khazragui, Hanan
AU - Noble, Sian
AU - Taylor, Hilary
AU - Tazewell, Marta
AU - Turner, Emma
AU - Wade, Julia
AU - Walsh, Eleanor
AU - Baker, Susan
AU - Bellis-Sheldon, Elizabeth
AU - Bougard, Chantal
AU - Bowtell, Joanne
AU - Brewer, Catherine
AU - Burton, Chris
AU - Charlton, Jennie
AU - Christoforou, Nicholas
AU - Clark, Rebecca
AU - Coull, Susan
AU - Croker, Christine
AU - Currer, Rosemary
AU - Daisey, Claire
AU - Delaney, Gill
AU - Donohue, Rose
AU - Drew, Jane
AU - Farmer, Rebecca
AU - Fry, Susan
AU - Haddow, Jean
AU - Hale, Alex
AU - Halpin, Susan
AU - Harris, Belle
AU - Hattrick, Barbara
AU - Holmes, Sharon
AU - Hunt, Helen
AU - Jackson, Vicky
AU - Johnson, Donna
AU - Le Butt, Mandy
AU - Leworthy, Jo
AU - Liddiatt, Tanya
AU - Martin, Alex
AU - Mauree, Jainee
AU - Moore, Susan
AU - Moulam, Gill
AU - Mutch, Jackie
AU - Nash, Alena
AU - Parker, Kathleen
AU - Pawsey, Christopher
AU - Purdie, Michelle
AU - Robson, Teresa
AU - Smith, Lynne
AU - Snoeck, Jo
AU - Stenton, Carole
AU - Steuart-Feilding, Tom
AU - Sully, Chris
AU - Sutton, Caroline
AU - Torrington, Carol
AU - Wilkins, Zoe
AU - Williams, Sharon
AU - Wilson, Andrea
AU - Grant, Adrian
AU - Roberts, Ian
AU - Ashby, Deborah
AU - Cowan, Richard
AU - Fayers, Peter
AU - Mellon, Killian
AU - N'Dow, James
AU - O'Brien, Tim
AU - ProtecT Study Group
N1 - 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.
PY - 2016/12/1
Y1 - 2016/12/1
N2 - 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.
AB - 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.
KW - functional status
KW - ISRCTN 20141297
KW - prostate cancer
KW - protect trial
KW - quality of life
KW - treatment
UR - http://www.scopus.com/inward/record.url?scp=84981710206&partnerID=8YFLogxK
U2 - 10.1111/bju.13582
DO - 10.1111/bju.13582
M3 - Article
C2 - 27415448
AN - SCOPUS:84981710206
VL - 118
SP - 869
EP - 879
JO - British Journal of Urology
JF - British Journal of Urology
SN - 1464-4096
IS - 6
ER -