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1. 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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3. Gleason drift in the NIHR ProtecT study

Author

Oxley, Jon, Simpkin, Andrew, Goepel, John, Varma, Murali, Griffiths, David, Grigor, Ken, Mayer, Nick, Warren, Anne, Deshmukh, Nayneeta, Bhattarai, Selina, Dormer, John, Hounsome, Luke, Adamczyk, Lukasz A, Metcalfe, Christopher, Lane, Athene J, Davis, Michael, Donovan, Jenny L, Neal, David E, Hamdy, Freddy C, and Robinson, Mary C

Published
2015
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4. 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

9. 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

10. The ProtecT trial: analysis of the patient cohort, baseline risk stratification and disease progression.

Author

Bryant, Richard J., Oxley, Jon, Young, Grace J., Lane, Janet A., Metcalfe, Chris, Davis, Michael, Turner, Emma L., Martin, Richard M., Goepel, John R., Varma, Murali, Griffiths, David F., Grigor, Ken, Mayer, Nick, Warren, Anne Y., Bhattarai, Selina, Dormer, John, Mason, Malcolm, Staffurth, John, Walsh, Eleanor, and Rosario, Derek J.

Subjects
DISEASE progression, PROPORTIONAL hazards models, COHORT analysis
Abstract

Objective: To test the hypothesis that the baseline clinico‐pathological features of the men with localized prostate cancer (PCa) included in the ProtecT (Prostate Testing for Cancer and Treatment) trial who progressed (n = 198) at a 10‐year median follow‐up were different from those of men with stable disease (n = 1409). Patients and Methods: We stratified the study participants at baseline according to risk of progression using clinical disease stage, pathological grade and PSA level, using Cox proportional hazard models. Results: The findings showed that 34% of participants (n = 505) had intermediate‐ or high‐risk PCa, and 66% (n = 973) had low‐risk PCa. Of 198 participants who progressed, 101 (51%) had baseline International Society of Urological Pathology Grade Group 1, 59 (30%) Grade Group 2, and 38 (19%) Grade Group 3 PCa, compared with 79%, 17% and 5%, respectively, for 1409 participants without progression (P < 0.001). In participants with progression, 38% and 62% had baseline low‐ and intermediate‐/high‐risk disease, compared with 69% and 31% of participants with stable disease (P < 0.001). Treatment received, age (65–69 vs 50–64 years), PSA level, Grade Group, clinical stage, risk group, number of positive cores, tumour length and perineural invasion were associated with time to progression (P ≤ 0.005). Men progressing after surgery (n = 19) were more likely to have a higher Grade Group and pathological stage at surgery, larger tumours, lymph node involvement and positive margins. Conclusions: We demonstrate that one‐third of the ProtecT cohort consists of people with intermediate‐/high‐risk disease, and the outcomes data at an average of 10 years' follow‐up are generalizable beyond men with low‐risk PCa. [ABSTRACT FROM AUTHOR]

Published
2020
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11. 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

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

Published
2016
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12. Gleason drift in the NIHR Protec T study.

Author

Oxley, Jon, Simpkin, Andrew, Goepel, John, Varma, Murali, Griffiths, David, Grigor, Ken, Mayer, Nick, Warren, Anne, Deshmukh, Nayneeta, Bhattarai, Selina, Dormer, John, Hounsome, Luke, Adamczyk, Lukasz A, Metcalfe, Christopher, Lane, J Athene, Davis, Michael, Donovan, Jenny L, Neal, David E, Hamdy, Freddy C, and Robinson, Mary C

Subjects
GLEASON grading system, PROSTATE cancer treatment, BIOPSY, PROSTATE-specific antigen, PROSTATECTOMY
Abstract

Aims There is increasing evidence of Gleason score ( GS) drift in prostatic core biopsies during the last two decades. The Protec T study is a randomized controlled study and provides an excellent cohort to study the effect of time, prostate-specific antigen ( PSA) level, perineural invasion, tumour length and age on GS. Methods and results The Protec T study recruited men in the United Kingdom between 1999 and 2010. The Gleason scores were grouped into four categories ≤3 + 3, 3 + 4, 4 + 3 and ≥4 + 4 for analysis. Data from England between 2000 and 2012 were also available. A total of 3282 biopsies containing cancer were analysed. For each year of the ProtecT study, the odds of being diagnosed with a higher GS category increased by 4.9%. Higher GS was also associated with perineural invasion, increasing tumour length, age and PSA level. While biopsy GS from England was incomplete, it also showed a marked decrease in GS five and six tumours during the same period. Conclusion There was GS drift from 3 + 3 to 3 + 4 with time in the ProtecT study, but there appeared to be no significant change in percentage of GS 4 + 3 or higher. This drift was less dramatic when compared to GS in the rest of England. [ABSTRACT FROM AUTHOR]

Published
2015
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18. CD4+ and CD8+ T-lymphocyte scores cannot reliably predict progression in patients with benign prostatic hyperplasia.

Author

Lamb, Alastair D., Qadan, Motaz, Roberts, Simon, Timlin, Hannah, Vowler, Sarah L., Campbell, Fiona M., Grigor, Ken, Bartlett, John M. S., and McNeill, S. Alan

Subjects
LYMPHOCYTES, BENIGN prostatic hyperplasia, DISEASE progression, ULTRASONIC imaging, BIOPSY, INFLAMMATION, THERAPEUTICS
Abstract

OBJECTIVE To determine whether the density of CD4+ and CD8+ T-lymphocytes in a transrectal ultrasonography (TRUS) biopsy of the prostate can be used to predict the progression of lower urinary tract symptoms (LUTS) in benign prostatic hyperplasia (BPH). PATIENTS AND METHODS In total, 100 patients were randomly selected from a pool of patients with histologically proven, benign TRUS biopsy specimens. There were seven full years of follow-up available. Clinical data were recorded, including prostate volume, International Prostate Symptom Score (IPSS), prostate-specific antigen, urine flow rate, postvoid residual urine volume and previous prostate surgery. Markers of disease progression included the subsequent development of acute urinary retention (AUR), ≥4 point rise in IPSS, prescription of medical therapy (α-blocker or 5-α-reductase inhibitor) and bladder outlet surgery. Four patients' specimens were unsuitable for analysis. Biopsy sections from 96 patients were immunohistochemically stained for the presence of CD4+ and CD8+ T-lymphocytes and the density of infiltrate was assessed using random field sampling and point counting. RESULTS Some 29% of patients (28/96) did not have BPH at the time of biopsy. Of all patients, 41% (39/96) progressed, 10% of whom (4/39) did not have BPH at the time of biopsy. A further 10% (10/96) developed AUR, 7% (7/96) had a ≥4 point rise in IPSS, 33% (32/96) required medical therapy for BPH and 11% (11/96) required bladder outlet surgery. There was low correlation between CD4+ and CD8+ densities in paired sections. CD4+ and CD8+ densities did not provide any significant predictive function in the progression of BPH, nor was their any predictive association noted between CD4+ and CD8+ scores and the development of prostate cancer. Sub-analysis did show that a threshold mean of ≥1.35 CD8+ cells per field predicted progression to AUR with a sensitivity of 60% (95% confidence interval, CI, 26.2-87.8), specificity of 73.3% (95% CI 62.6-82.2) but a positive predictive value of 20.6% (95% CI 8.0-39.7). CD4+ infiltrate density suggested a trend to general progression but without statistical significance. CONCLUSION The present study, despite certain trends, shows no evidence for an association between CD4+ and CD8+ T-lymphocytes and the progression of LUTS in BPH. [ABSTRACT FROM AUTHOR]

Published
2011
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19. The loss of 5alpha-reductase type I and type II mRNA expression in metastatic prostate cancer to bone and lymph node metastasis.

Author

Habib FK, Ross M, Bayne CW, Bollina P, Grigor K, and Chapman K

Subjects
3-Oxo-5-alpha-Steroid 4-Dehydrogenase genetics, 3-Oxo-5-alpha-Steroid 4-Dehydrogenase metabolism, Bone Neoplasms secondary, Humans, Immunoenzyme Techniques, In Situ Hybridization, Lymph Nodes pathology, Lymphatic Metastasis, Male, Paraffin Embedding, Prostate-Specific Antigen genetics, Prostatic Neoplasms pathology, Receptors, Androgen analysis, Receptors, Androgen genetics, Bone Neoplasms metabolism, Gene Expression Regulation, Neoplastic, Lymph Nodes metabolism, Prostatic Neoplasms metabolism, RNA, Messenger metabolism
Abstract

Purpose: Considerable evidence has accumulated demonstrating that the 5alpha-reduction of testosterone to dihydrotestosterone occurs more efficiently in the normal and benign hyperplastic prostate than in prostate cancer tissues. Efforts have also been channeled into investigating the distribution of 5alpha-reductase isoenzymes in primary prostate tissues and in "in vitro" cell models of the human prostate. However, no one has, thus far, examined the expression of these isoenzymes in prostate cancer metastasis, although such studies might shed some light on the mechanism(s) responsible for the loss of hormone sensitivity in those tumors. The present report addresses this issue in the hope that this might help to identify the steps leading to the development of prostate cancer metastasis., Experimental Design: In the present study we used in situ mRNA hybridization of sections from archival paraffin-embedded material to investigate the expression of 5alpha-reductase type I (5alphaR-I) and type II (5alphaR-II) mRNAs in prostate cancer bony (n = 9) and lymph node (n = 13) metastasis, and compared the mRNA distributions with those observed in sections from primary prostate tumors (n = 12). In parallel, sections were investigated for androgen receptor (AR) mRNA expression, and immunostained for AR and prostate-specific antigen., Results: Neither 5alphaR-I nor 5alphaR-II mRNA expression was detected in any of the prostate metastatic lesions, although the same metastatic sites expressed AR mRNA, and stained for cytoplasmic prostate-specific antigen and nuclear AR. In contrast, primary prostate tumors displayed intense staining for 5alphaR-I and 5alphaR-II., Conclusion: These findings suggest that the loss of 5alpha-reductase mRNA expression in bone and lymph node metastasis may be associated, in part, with the progression of these tumors to androgen insensitivity.

Published
2003

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