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3. 128 Impact of biological response-based adaptive radiotherapy on doses to swallowing OARS in modelled IMPT plans.

Author

Hargreaves, Sarah, Woodley, Owain, Lambert, Jamil, Maggs, Rhydian, Rackley, Thomas, and Evans, Mererid

Subjects
*PROTON therapy, *HEAD & neck cancer, *VOLUMETRIC-modulated arc therapy, *SHORT bowel syndrome, *RADIOTHERAPY, *PHARYNGEAL muscles, *MEDICAL dosimetry
Abstract

The PEARL study is a phase 2 multi-centre trial for good prognosis HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) patients, currently open in the UK. PEARL is investigating the dosimetric impact of re-planning a radical radiotherapy plan midway through a course of treatment, based upon the biological response of the primary GTV on 18 FDG PET-CT. With the wider availability of proton beam therapy in the form of Intensity Modulated Proton Therapy (IMPT) as a potential option for radiotherapy in the management of OPSCC, in addition to substantial cost implications, improving methods to determine the patients who will benefit most from IMPT is required. The organ sparing benefits of IMPT are well documented. This modelling planning study investigated whether the benefits of proton therapy can be improved by applying biological response-based adaptation as per the PEARL study planning method. Objectives: 1. Investigate the dosimetric impact of IMPT by comparing mean dose received by swallowing OARs (SWOARs) between non-adaptive VMAT and non-adapted IMPT plans 2. Investigate the dosimetric impact of adaptation by comparing dose received by SWOARs between non-adaptive IMPT and adapted IMPT plans 3. Investigate the relative dosimetric impact of adaptation by comparing dose received by SWOARs between adaptive VMAT and IMPT plans 4. Identify whether adaptation as per the PEARL Study protocol would influence the delta normal tissue complication probability (ΔNTCP) threshold for proton beam therapy funding in The Netherlands Anonymized patient datasets were used to model VMAT and IMPT plans using RayStation and optimised for SWOARs. The following plans were generated: 1. 'NON-ADAPTIVE': Manually planned non-adapted VMAT 2. 'ADAPTIVE': Manually planned adapted VMAT 3. 'NON-ADAPTIVE_PROTON': Manually planned non-adapted IMPT 4. 'ADAPTIVE_PROTON': Manually planned adapted IMPT NTCP calculations for dysphagia risk we performed using the validated dysphagia model described by Christianen et al (1). Individual calculations were performed on each case comparing adapted and non-adapted VMAT plans to non-adapted IMPT plans to explore whether they reached the threshold for proton beam treatment funding as per The Netherlands scheme. Mean dose to the superior pharyngeal constrictor muscle and the supraglottis was entered into the following calculation: 1/NTCP = (1+ e)– s where s = -6.09 + (mean dose to the superior pharyngeal constrictor muscle x 0.057) + (mean dose to the supraglottis × 0.037) All cases had a reduction in their total mean dose to SWOARs, adapted as per PEARL, and planned with IMPT. The magnitude of impact was ranked in the same order for all cases, with optimisation reducing the total mean dose the least, and adapted IMPT the most. Cases 1 and 2, and Cases 3 and 4, demonstrated similar total mean dose reductions despite having different degrees of biological GTV reduction on the iPET-CT. Adaptation had the greatest impact on Cases 2 and 3 for both VMAT and IMPT plans. [Display omitted] The NTCP differences between non-adaptive VMAT plans and non-adaptive IMPT plans were >10% suggesting these cases would be candidates for IMPT funding as as per the National Indication Protocol Proton therapy (NIPP) - head and neck cancer criteria in The Netherlands. Whilst primarily limited by the small number of cases, we have demonstrated that IMPT markedly reduces doses to SWOARs compared to VMAT planning in line with widely published studies. We have also demonstrated that adaptation based on the biological response to the tumour after 2 weeks of chemoradiotherapy can further improve the tissue sparing already achieved with IMPT. This is the first study to demonstrate that SWOAR sparing by IMPT can be improved with biological response guided adaptive radiotherapy. Our results are in line with published data that IMPT can spare many head and neck SWOARs to a greater extent than VMAT in the treatment of oropharyngeal cancers. In the cases studied here, the impact of IMPT on the mean dose to SWOARs was greater than the impact of adaptation, when compared to standard VMAT planning. However, there may be additional dosimetric benefit when IMPT is adapted to tumour response during a course of radiotherapy treatment, particularly dose to more caudal SWOARs. In this small cohort, adaptation on VMAT plans was unlikely to have affected a decision for IMPT treatment as per the Netherlands NTCP-based algorithm. Further work with a larger cohort of patients, as well as real-time studies to collect prospective clinical data on xerostomia and dysphagia rates, is required to properly investigate the clinical advantages of adaptive IMPT. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Radiotherapy for Prostate Cancer: is it ‘what you do’ or ‘the way that you do it’? A UK Perspective on Technique and Quality Assurance

Author

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, Graham, James, Nick, Law, Alastair, Loughrey, Carmel, Mason, Malcolm, 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, Dedman, Dan, Down, Elizabeth, Khazragui, Hanan, Metcalfe, Chris, Noble, Sian, Peters, Tim, Taylor, Hilary, 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, Parker, Kathleen, Pawsey, Christopher, Purdie, Michelle, Robson, Teresa, Smith, Lynne, 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, Sokhal, Michael, Baum, Michael, Adolfson, Jan, Albertsen, Peter, Dearnaley, David, Schroeder, Fritz, Roberts, Tracy, Zietman, Anthony, Mason, M.D., Moore, R., Jones, G., Lewis, G., Donovan, J.L., Neal, D.E., Hamdy, F.C., Lane, J.A., and Staffurth, J.N.

Published
2016
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5. Ten-year mortality, disease progression, and treatment-related side effects in men with localised prostate cancer from the ProtecT randomised controlled trial according to treatment received

Author

Neal, David E., Metcalfe, Chris, Donovan, Jenny L., Lane, J. Athene, Davis, Michael, Young, Grace J., Dutton, Susan J., Walsh, Eleanor I., Martin, Richard M., Peters, Tim. J., Turner, Emma L., Mason, Malcolm, Bryant, Richard, Bollina, Prasad, Catto, James, Doherty, Alan, Gillatt, David, Gnanapragasam, Vincent, Holding, Peter, Hughes, Owen, Kockelbergh, Roger, Kynaston, Howard, Oxley, Jon, Paul, Alan, Paez, Edgar, Rosario, Derek J., Rowe, Edward, Staffurth, John, Altman, Doug G., Hamdy, Freddie C., Peters, Tim J., Doble, Andrew, Powell, Philip, Prescott, Stephen, Rosario, Derek, Anderson, John B., Aning, Jonathan, Durkan, Garett, Koupparis, Anthony, Leung, Hing, Mariappan, Param, McNeill, Alan, Persad, Raj, Schwaibold, Hartwig, Tulloch, David, Wallace, Michael, Bonnington, Susan, Bradshaw, Lynne, Cooper, Deborah, Elliott, Emma, Herbert, Phillipa, Howson, Joanne, Jones, Amanda, Lennon, Teresa, Lyons, Norma, Moody, Hilary, Plumb, Claire, O'Sullivan, Tricia, Salter, Elizabeth, Thompson, Pauline, Tidball, Sarah, Blaikie, Jan, Gray, Catherine, Adam, Tonia, Askew, Sarah, Atkinson, Sharon, Baynes, Tim, Brain, Carole, Breen, Viv, Brunt, Sarah, Bryne, Sean, Bythem, Jo, Clarke, Jenny, Cloete, Jenny, Dark, Susan, Davis, Gill, Rue, Rachael De La, Denizot, Jane, Dewhurst, Elspeth, Dimes, Anna, Dixon, Nicola, Ebbs, Penny, Emmerson, Ingrid, Ferguson, Jill, Gadd, Ali, Geoghegan, Lisa, Grant, Alison, Grant, Collette, 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, Ellie, 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, Bahl, Amit, Benson, Richard, Beresford, Mark, Ferguson, Catherine, Graham, John, Herbert, Chris, Howard, Grahame, James, Nick, Kirkbride, Peter, Law, Alastair, Loughrey, Carmel, McClaren, Duncan, Patterson, Helen, Pedley, Ian, Roberts, Trevor, Robinson, Angus, Russell, Simon, Symonds, Paul, Thanvi, Narottam, Vasanthan, Subramaniam, Wilson, Paula, Robinson, Mary, Bhattarai, Selina, Deshmukh, Neeta, Dormer, John, Fernando, Malee, Goepel, John, Griffiths, David, Grigor, Ken, Mayer, Nick, Varma, Murali, Warren, Anne, 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, Shuttleworth, Pam, Slade, Stephen, Steele, Alasdair, Swinscoe, James, Tiffany, Marie, Townley, John, Treeby, Jo, Weston, Michael, Wilkinson, Joyce, Williams, Lorraine, Wills, Lucy, Woodley, Owain, Yarrow, Sue, Brindle, Lucy, Davies, Linda, Dedman, Dan, Down, Elizabeth, Khazragui, Hanan, Noble, Sian, Taylor, Hilary, Tazewell, Marta, 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, Parker, Kathleen, Pawsey, Christopher, Purdie, Michelle, Robson, Teresa, Smith, Lynne, Stenton, Carole, Steuart-Feilding, Tom, Stott, Beth, Sully, Chris, Sutton, Caroline, Torrington, Carol, Wilkins, Zoe, Williams, Sharon, Wilson, Andrea, Weaver, Ashleigh, Albertsen, Peter, Adolfsson, Jan, Baum, Michael, McFarlane, Jon, Reid, Colette, Turner, Emma, Zietman, Anthony, Hill, Elizabeth, Ng, Siaw Yein, Williams, Naomi, Toole, Jessica, Davies, Charlotte, Hughes, Laura, Rowlands, Mari-Anne, Bell, Lindsey, Harrison, Sean, Mauree, Jainnee, Grant, Adrian, Roberts, Ian, Ashby, Deborah, Cowan, Richard, Fayers, Peter, Mellon, Killian, N’Dow, James, O’Brien, Tim, Sokhal, Michael, Dearnaley, David, Schröder, Fritz, Roberts, Tracy, and for the ProtecT Study Group, .

Subjects
Male, medicine.medical_specialty, Time Factors, Urology, medicine.medical_treatment, 030232 urology & nephrology, Urinary incontinence, Active monitoring, BTC (Bristol Trials Centre), Metastasis, law.invention, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, ProtecT trial, Randomized controlled trial, law, Internal medicine, Humans, Medicine, External beam radiotherapy, Watchful Waiting, Aged, Prostatectomy, Disease progression, Radiotherapy, business.industry, Prostatic Neoplasms, Middle Aged, medicine.disease, Radical prostatectomy, Treatment Outcome, 030220 oncology & carcinogenesis, Propensity score matching, Cohort, Disease Progression, BRTC, medicine.symptom, Sexual function, business, Literatur Kommentiert
Abstract

Background: The ProtecT trial reported intention-to-treat analysis of men with localised prostate cancer (PCa) randomly allocated to active monitoring (AM), radical prostatectomy, and external beam radiotherapy. Objective: To determine report outcomes according to treatment received in men in randomised and treatment choice cohorts. Design, Setting, and Participants: This study focuses on secondary care. Men with clinically localised prostate cancer at one of nine UK centres were invited to participate in the treatment trial comparing AM, radical prostatectomy, and radiotherapy. Intervention: Two cohorts included 1643 men who agreed to be randomised; 997 declined randomisation and chose treatment. Outcome Measurements and Statistical Analysis: Health-related quality of life impacts on urinary, bowel, and sexual function were assessed using patient-reported outcome measures. Analysis was carried out based on treatment received for each cohort and on pooled estimates using meta-analysis. Differences were estimated with adjustment for known prognostic factors using propensity scores. Results and Limitations: According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p = 0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p = 0.003). There was also strong evidence that metastasis (AM 5.6%, surgery 2.4%, radiotherapy 2.7%) and disease progression (AM 20.35%, surgery 5.87%, radiotherapy 6.62%) were more common in the AM group. Compared with AM, there were higher risks of sexual dysfunction (95% at 6 mo) and urinary incontinence (55% at 6 mo) after surgery, and of sexual dysfunction (88% at 6 mo) and bowel dysfunction (5% at 6 mo) after radiotherapy. The key limitations are the potential for bias when comparing groups defined by treatment received and outdating of the interventions being evaluated during the lengthy follow-up required in trials of screen-detected PCa. Conclusions: Analyses according to treatment received showed increased rates of disease-related events and lower rates of patient-reported harms in men managed by AM compared with men managed by radical treatment, and stronger evidence of greater PCa mortality in the AM group. Patient Summary: More than 90 out of every 100 men with localised prostate cancer do not die of prostate cancer within 10 yr, irrespective of whether treatment is by means of monitoring, surgery, or radiotherapy. Side effects on sexual and bladder function are much better after active monitoring, but the risks of spreading of prostate cancer are more common.

Published
2020

6. 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

Author

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, Sokhal, Michael, Baum, Michael, Adolfson, Jan, Albertsen, Peter, Dearnaley, David, Schroeder, Fritz, Roberts, Tracy, and Zietman, Anthony

Subjects
Male, Urological Oncology, functional status, law.invention, Prostate cancer, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, 030212 general & internal medicine, media_common, treatment, Middle Aged, Urology & Nephrology, prostate cancer, Treatment Outcome, Centre for Surgical Research, 030220 oncology & carcinogenesis, Functional status, BRTC, Sexuality, medicine.medical_specialty, Urology, Urinary system, media_common.quotation_subject, Urination, Social class, BTC (Bristol Trials Centre), 03 medical and health sciences, ProtecT trial, Digestive System Physiological Phenomena, Internal medicine, medicine, Humans, Patient Reported Outcome Measures, Aged, business.industry, Prostatic Neoplasms, 1103 Clinical Sciences, protect trial, medicine.disease, Treatment, ISRCTN 20141297, Physical therapy, Quality of Life, Sexual function, business
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.

Published
2016

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