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1. Factors associated with trial recruitment, preferences, and treatments received were elucidated in a comprehensive cohort study

Author

Holding, Peter, Mason, Malcolm, Catto, James W.F., Rosario, Derek J., Staffurth, John, Kynaston, Howard, Hughes, Owen, Bollina, Prasad, Doherty, Alan, Gnanapragasam, Vincent, Kockelbergh, Roger, Paul, Alan, Paez, Edgar, Gillatt, David, Rowe, Edward, Oxley, Jon, Donovan, Jenny L., Opmeer, Brent, Young, Grace J., Mills, Nicola, Martin, Richard M., Lane, J. Athene, Metcalfe, Chris, Peters, Tim J., Davis, Michael, Turner, Emma L., Walsh, Eleanor, Neal, David E., and Hamdy, Freddie C.

Published
2019
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2. A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial

Author

Bollina, Prasad, Catto, James, Doble, Andrew, Doherty, Alan, Gillatt, David, Gnanapragasam, Vincent, Holding, Peter, Hughes, Owen, Kockelbergh, Roger, Kynaston, Howard, Mason, Malcolm, Oxley, Jon, Paul, Alan, Paez, Edgar, Rosario, Derek J., Rowe, Edward, Staffurth, John, Donovan, Jenny L., Young, Grace J., Walsh, Eleanor I., Metcalfe, Chris, Lane, J. Athene, Martin, Richard M., Tazewell, Marta K., Davis, Michael, Peters, Tim J., Turner, Emma L., Mills, Nicola, Khazragui, Hanan, Khera, Tarnjit K., Neal, David E., and Hamdy, Freddie C.

Published
2018
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3. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer

Author

Hamdy, Freddie C., primary, Donovan, Jenny L., additional, Lane, J. Athene, additional, Metcalfe, Chris, additional, Davis, Michael, additional, Turner, Emma L., additional, Martin, Richard M., additional, Young, Grace J., additional, Walsh, Eleanor I., additional, Bryant, Richard J., additional, Bollina, Prasad, additional, Doble, Andrew, additional, Doherty, Alan, additional, Gillatt, David, additional, Gnanapragasam, Vincent, additional, Hughes, Owen, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Paul, Alan, additional, Paez, Edgar, additional, Powell, Philip, additional, Rosario, Derek J., additional, Rowe, Edward, additional, Mason, Malcolm, additional, Catto, James W.F., additional, Peters, Tim J., additional, Oxley, Jon, additional, Williams, Naomi J., additional, Staffurth, John, additional, and Neal, David E., additional

Published
2023
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4. Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment

Author

Donovan, Jenny L., primary, Hamdy, Freddie C., additional, Lane, J. Athene, additional, Young, Grace J., additional, Metcalfe, Chris, additional, Walsh, Eleanor I., additional, Davis, Michael, additional, Steuart-Feilding, Thomas, additional, Blazeby, Jane M., additional, Avery, Kerry N. L., additional, Martin, Richard M., additional, Bollina, Prasad, additional, Doble, Andrew, additional, Doherty, Alan, additional, Gillatt, David, additional, Gnanapragasam, Vincent, additional, Hughes, Owen, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Paul, Alan, additional, Paez, Edgar, additional, Powell, Phillip, additional, Rosario, Derek J., additional, Rowe, Edward, additional, Mason, Malcolm, additional, Catto, James W. F., additional, Peters, Tim J., additional, Wade, Julia, additional, Turner, Emma L., additional, Williams, Naomi J., additional, Oxley, Jon, additional, Staffurth, John, additional, Bryant, Richard J., additional, and Neal, David E., additional

Published
2023
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5. 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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8. Four‐year outcomes from a multiparametric magnetic resonance imaging (MRI)‐based active surveillance programme: PSA dynamics and serial MRI scans allow omission of protocol biopsies

Author

Gallagher, Kevin Michael, Christopher, Edward, Cameron, Andrew James, Little, Scott, Innes, Alasdair, Davis, Gill, Keanie, Julian, Bollina, Prasad, and McNeill, Alan

Subjects
Urological Oncology, active surveillance, MRI scan, prostate biopsy, prostate cancer
Abstract

Objectives To report outcomes from a multiparametric (mp) magnetic resonance imaging (MRI)‐based active surveillance programme that did not include performing protocol biopsies after the first confirmatory biopsy. Patients and Methods All patients diagnosed with Gleason 3 + 3 prostate cancer because of a raised PSA level who underwent mpMRI after diagnosis were included. Patients were recorded in a prospective clinical database and followed up with PSA monitoring and repeat MRI. In patients who remained on active surveillance after the first MRI (with or without confirmatory biopsy), we investigated PSA dynamics for association with subsequent progression. Comparison between first and second MRI scans was undertaken. Outcomes assessed were: progression to radical therapy at first MRI/confirmatory biopsy and progression to radical therapy in those who remained on active surveillance after first MRI. Results A total of 211 patients were included, with a median of 4.2 years of follow‐up. The rate of progression to radical therapy was significantly greater at all stages among patients with visible lesions than in those with initially negative MRI (47/125 (37.6%) vs 11/86 (12.8%); odds ratio 4.1 (95% CI 2.0–8.5), P < 0.001). Only 1/56 patients (1.8%) with negative initial MRI scans who underwent a confirmatory systematic biopsy had upgrading to Gleason 3 + 4 disease. PSA velocity was significantly associated with subsequent progression in patients with negative initial MRI (area under the curve 0.85 [95% CI 0.75–0.94]; P

Published
2018

10. Functional and quality of life outcomes of localised prostate cancer treatments (Prostate Testing for Cancer and Treatment [ProtecT] study).

Author

Lane, Janet Athene, Donovan, Jenny L., Young, Grace J., Davis, Michael, Walsh, Eleanor I., Avery, Kerry N.L., Blazeby, Jane M., Mason, Malcolm D., Martin, Richard M., Peters, Tim J., Turner, Emma L., Wade, Julia, Bollina, Prasad, Catto, James W.F., Doherty, Alan, Gillatt, David, Gnanapragasam, Vincent, Hughes, Owen, Kockelbergh, Roger, and Kynaston, Howard

Subjects
PROSTATE cancer, CANCER treatment, PATIENT reported outcome measures, RADICAL prostatectomy, QUALITY of life, FECAL incontinence
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. [ABSTRACT FROM AUTHOR]

Published
2022
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11. 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

12. Strategies adopted by men to deal with uncertainty and anxiety when following an active surveillance/monitoring protocol for localised prostate cancer and implications for care: a longitudinal qualitative study embedded within the ProtecT trial

Author

Wade, Julia, primary, Donovan, Jenny, additional, Lane, Athene, additional, Davis, Michael, additional, Walsh, Eleanor, additional, Neal, David, additional, Turner, Emma, additional, Martin, Richard, additional, Metcalfe, Chris, additional, Peters, Tim, additional, Hamdy, Freddie, additional, Kockelbergh, Roger, additional, Catto, James, additional, Paul, Alan, additional, Holding, Peter, additional, Rosario, Derek, additional, Kynaston, Howard, additional, Rowe, Edward, additional, Hughes, Owen, additional, Bollina, Prasad, additional, Gillatt, David, additional, Doherty, Alan, additional, Gnanapragasam, Vincent J, additional, and Paez, Edgar, additional

Published
2020
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13. Erratum to ‘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’ [European Urology 77 (2020) 320–330]

Author

Neal, David E., primary, Metcalfe, Chris, additional, Donovan, Jenny L., additional, Lane, J. Athene, additional, Davis, Michael, additional, Young, Grace J., additional, Dutton, Susan J., additional, Walsh, Eleanor I., additional, Martin, Richard M., additional, Peters, Tim. J., additional, Turner, Emma L., additional, Mason, Malcolm, additional, Bryant, Richard, additional, Bollina, Prasad, additional, Catto, James, additional, Doherty, Alan, additional, Gillatt, David, additional, Gnanapragasam, Vincent, additional, Holding, Peter, additional, Hughes, Owen, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Oxley, Jon, additional, Paul, Alan, additional, Paez, Edgar, additional, Rosario, Derek J., additional, Rowe, Edward, additional, Staffurth, John, additional, Altman, Doug G., additional, and Hamdy, Freddie C., additional

Published
2020
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14. Active monitoring, radical prostatectomy and radical radiotherapy in PSA-detected clinically localised prostate cancer: the ProtecT three-arm RCT

Author

Hamdy, Freddie C, primary, Donovan, Jenny L, additional, Lane, J Athene, additional, Mason, Malcolm, additional, Metcalfe, Chris, additional, Holding, Peter, additional, Wade, Julia, additional, Noble, Sian, additional, Garfield, Kirsty, additional, Young, Grace, additional, Davis, Michael, additional, Peters, Tim J, additional, Turner, Emma L, additional, Martin, Richard M, additional, Oxley, Jon, additional, Robinson, Mary, additional, Staffurth, John, additional, Walsh, Eleanor, additional, Blazeby, Jane, additional, Bryant, Richard, additional, Bollina, Prasad, additional, Catto, James, additional, Doble, Andrew, additional, Doherty, Alan, additional, Gillatt, David, additional, Gnanapragasam, Vincent, additional, Hughes, Owen, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Paul, Alan, additional, Paez, Edgar, additional, Powell, Philip, additional, Prescott, Stephen, additional, Rosario, Derek, additional, Rowe, Edward, additional, and Neal, David, additional

Published
2020
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15. The ProtecT randomised trial cost-effectiveness analysis comparing active monitoring, surgery, or radiotherapy for prostate cancer

Author

Noble, Sian M., primary, Garfield, Kirsty, additional, Lane, J. Athene, additional, Metcalfe, Chris, additional, Davis, Michael, additional, Walsh, Eleanor I., additional, Martin, Richard M., additional, Turner, Emma L., additional, Peters, Tim J., additional, Thorn, Joanna C., additional, Mason, Malcolm, additional, Bollina, Prasad, additional, Catto, James W. F., additional, Doherty, Alan, additional, Gnanapragasam, Vincent, additional, Hughes, Owen, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Paul, Alan, additional, Paez, Edgar, additional, Rosario, Derek J., additional, Rowe, Edward, additional, Oxley, Jon, additional, Staffurth, John, additional, Neal, David E., additional, Hamdy, Freddie C., additional, and Donovan, Jenny L., additional

Published
2020
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22. Factors associated with trial recruitment, preferences, and treatments received were elucidated in a comprehensive cohort study

Author

Donovan, Jenny L., primary, Opmeer, Brent, additional, Young, Grace J., additional, Mills, Nicola, additional, Martin, Richard M., additional, Lane, J. Athene, additional, Metcalfe, Chris, additional, Peters, Tim J., additional, Davis, Michael, additional, Turner, Emma L., additional, Walsh, Eleanor, additional, Neal, David E., additional, Hamdy, Freddie C., additional, Holding, Peter, additional, Mason, Malcolm, additional, Catto, James W.F., additional, Rosario, Derek J., additional, Staffurth, John, additional, Kynaston, Howard, additional, Hughes, Owen, additional, Bollina, Prasad, additional, Doherty, Alan, additional, Gnanapragasam, Vincent, additional, Kockelbergh, Roger, additional, Paul, Alan, additional, Paez, Edgar, additional, Gillatt, David, additional, Rowe, Edward, additional, and Oxley, Jon, additional

Published
2019
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23. Couple-based psychosexual support following prostate cancer surgery: Results of a feasibility pilot randomized control trial

Author

McNamee, Phillip, McNeill, Alan, Bollina, Prasad, Robertson, Jane, McNamee, Philip, Molloy, Gerry, Hubbard, Gill, McNeill, S Alan, Bollina, Prasad R, Kelly, Daniel, and Forbat, Liz

Subjects
Family Systems, Treatment, Sex Therapy, Psychosexual Support, Prostate Cancer, Couple Therapy, Relationships, Intimacy, Sexual Function
Abstract

Introduction: Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. Aims: To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. Methods: Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. Main Outcome Measures: The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. Results: The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. Conclusion: The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this intervention, and future trials would benefit from a couple-focused measurement.

Published
2016

24. 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

26. A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial

Author

Donovan, Jenny L., primary, Young, Grace J., additional, Walsh, Eleanor I., additional, Metcalfe, Chris, additional, Lane, J. Athene, additional, Martin, Richard M., additional, Tazewell, Marta K., additional, Davis, Michael, additional, Peters, Tim J., additional, Turner, Emma L., additional, Mills, Nicola, additional, Khazragui, Hanan, additional, Khera, Tarnjit K., additional, Neal, David E., additional, Hamdy, Freddie C., additional, Bollina, Prasad, additional, Catto, James, additional, Doble, Andrew, additional, Doherty, Alan, additional, Gillatt, David, additional, Gnanapragasam, Vincent, additional, Holding, Peter, additional, Hughes, Owen, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Mason, Malcolm, additional, Oxley, Jon, additional, Paul, Alan, additional, Paez, Edgar, additional, Rosario, Derek J., additional, Rowe, Edward, additional, and Staffurth, John, additional

Published
2018
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27. Mortality Among Men with Advanced Prostate Cancer Excluded from the ProtecT Trial

Author

Johnston, Thomas J., primary, Shaw, Greg L., additional, Lamb, Alastair D., additional, Parashar, Deepak, additional, Greenberg, David, additional, Xiong, Tengbin, additional, Edwards, Alison L., additional, Gnanapragasam, Vincent, additional, Holding, Peter, additional, Herbert, Phillipa, additional, Davis, Michael, additional, Mizielinsk, Elizabeth, additional, Lane, J. Athene, additional, Oxley, Jon, additional, Robinson, Mary, additional, Mason, Malcolm, additional, Staffurth, John, additional, Bollina, Prasad, additional, Catto, James, additional, Doble, Andrew, additional, Doherty, Alan, additional, Gillatt, David, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Prescott, Steve, additional, Paul, Alan, additional, Powell, Philip, additional, Rosario, Derek, additional, Rowe, Edward, additional, Donovan, Jenny L., additional, Hamdy, Freddie C., additional, and Neal, David E., additional

Published
2017
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28. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer

Author

Donovan, Jenny L., primary, Hamdy, Freddie C., additional, Lane, J. Athene, additional, Mason, Malcolm, additional, Metcalfe, Chris, additional, Walsh, Eleanor, additional, Blazeby, Jane M., additional, Peters, Tim J., additional, Holding, Peter, additional, Bonnington, Susan, additional, Lennon, Teresa, additional, Bradshaw, Lynne, additional, Cooper, Deborah, additional, Herbert, Phillipa, additional, Howson, Joanne, additional, Jones, Amanda, additional, Lyons, Norma, additional, Salter, Elizabeth, additional, Thompson, Pauline, additional, Tidball, Sarah, additional, Blaikie, Jan, additional, Gray, Catherine, additional, Bollina, Prasad, additional, Catto, James, additional, Doble, Andrew, additional, Doherty, Alan, additional, Gillatt, David, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Paul, Alan, additional, Powell, Philip, additional, Prescott, Stephen, additional, Rosario, Derek J., additional, Rowe, Edward, additional, Davis, Michael, additional, Turner, Emma L., additional, Martin, Richard M., additional, and Neal, David E., additional

Published
2016
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29. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer

Author

Hamdy, Freddie C., primary, Donovan, Jenny L., additional, Lane, J. Athene, additional, Mason, Malcolm, additional, Metcalfe, Chris, additional, Holding, Peter, additional, Davis, Michael, additional, Peters, Tim J., additional, Turner, Emma L., additional, Martin, Richard M., additional, Oxley, Jon, additional, Robinson, Mary, additional, Staffurth, John, additional, Walsh, Eleanor, additional, Bollina, Prasad, additional, Catto, James, additional, Doble, Andrew, additional, Doherty, Alan, additional, Gillatt, David, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Paul, Alan, additional, Powell, Philip, additional, Prescott, Stephen, additional, Rosario, Derek J., additional, Rowe, Edward, additional, and Neal, David E., additional

Published
2016
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30. Four‐year outcomes from a multiparametric magnetic resonance imaging (MRI)‐based active surveillance programme: PSA dynamics and serial MRI scans allow omission of protocol biopsies.

Author

Gallagher, Kevin Michael, Christopher, Edward, Cameron, Andrew James, Little, Scott, Innes, Alasdair, Davis, Gill, Keanie, Julian, Bollina, Prasad, and McNeill, Alan

Subjects
CASTRATION-resistant prostate cancer
Abstract

Objectives: To report outcomes from a multiparametric (mp) magnetic resonance imaging (MRI)‐based active surveillance programme that did not include performing protocol biopsies after the first confirmatory biopsy. Patients and Methods: All patients diagnosed with Gleason 3 + 3 prostate cancer because of a raised PSA level who underwent mpMRI after diagnosis were included. Patients were recorded in a prospective clinical database and followed up with PSA monitoring and repeat MRI. In patients who remained on active surveillance after the first MRI (with or without confirmatory biopsy), we investigated PSA dynamics for association with subsequent progression. Comparison between first and second MRI scans was undertaken. Outcomes assessed were: progression to radical therapy at first MRI/confirmatory biopsy and progression to radical therapy in those who remained on active surveillance after first MRI. Results: A total of 211 patients were included, with a median of 4.2 years of follow‐up. The rate of progression to radical therapy was significantly greater at all stages among patients with visible lesions than in those with initially negative MRI (47/125 (37.6%) vs 11/86 (12.8%); odds ratio 4.1 (95% CI 2.0–8.5), P < 0.001). Only 1/56 patients (1.8%) with negative initial MRI scans who underwent a confirmatory systematic biopsy had upgrading to Gleason 3 + 4 disease. PSA velocity was significantly associated with subsequent progression in patients with negative initial MRI (area under the curve 0.85 [95% CI 0.75–0.94]; P <0.001). Patients with high‐risk visible lesions on first MRI who remained on active surveillance had a high risk of subsequent progression 19/76 (25.0%) vs 9/84 (10.7%) for patients with no visible lesions, despite reassuring targeted and systematic confirmatory biopsies and regardless of PSA dynamics. Conclusion: Men with low‐risk Gleason 3 + 3 prostate cancer on active surveillance can forgo protocol biopsies in favour of MRI and PSA monitoring with selective re‐biopsy. [ABSTRACT FROM AUTHOR]

Published
2019
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31. 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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39. Modelling the lifetime cost-effectiveness of radical prostatectomy, radiotherapy and active monitoring for men with clinically localised prostate cancer from median 10-year outcomes in the ProtecT randomised trial.

Author

Sanghera, S., Mohiuddin, S., Coast, J., Garfield, K., Noble, S., Metcalfe, C., Lane, J. A., Turner, E. L., Neal, D., Hamdy, F. C., Martin, R. M., Donovan, J. L., for the ProtecT study group, Bollina, Prasad, Doble, Andrew, Doherty, Alan, Gillatt, David, Gnanapragasam, Vincent, Hughes, Owen, and Kockelbergh, Roger

Subjects
PROSTATE cancer, PROSTATECTOMY, RANDOMIZED controlled trials, QUALITY-adjusted life years, COST effectiveness, RESEARCH, TIME, RESEARCH methodology, MEDICAL cooperation, EVALUATION research, MEDICAL protocols, COMPARATIVE studies, PROSTATE tumors
Abstract

Background: Optimal management strategies for clinically localised prostate cancer are debated. Using median 10-year data from the largest randomised controlled trial to date (ProtecT), the lifetime cost-effectiveness of three major treatments (radical radiotherapy, radical prostatectomy and active monitoring) was explored according to age and risk subgroups.Methods: A decision-analytic (Markov) model was developed and informed by clinical input. The economic evaluation adopted a UK NHS perspective and the outcome was cost per Quality-Adjusted Life Year (QALY) gained (reported in UK£), estimated using EQ-5D-3L.Results: Costs and QALYs extrapolated over the lifetime were mostly similar between the three randomised strategies and their subgroups, but with some important differences. Across all analyses, active monitoring was associated with higher costs, probably associated with higher rates of metastatic disease and changes to radical treatments. When comparing the value of the strategies (QALY gains and costs) in monetary terms, for both low-risk prostate cancer subgroups, radiotherapy generated the greatest net monetary benefit (£293,446 [95% CI £282,811 to £299,451] by D'Amico and £292,736 [95% CI £284,074 to £297,719] by Grade group 1). However, the sensitivity analysis highlighted uncertainty in the finding when stratified by Grade group, as radiotherapy had 53% probability of cost-effectiveness and prostatectomy had 43%. In intermediate/high risk groups, using D'Amico and Grade group > = 2, prostatectomy generated the greatest net monetary benefit (£275,977 [95% CI £258,630 to £285,474] by D'Amico and £271,933 [95% CI £237,864 to £287,784] by Grade group). This finding was supported by the sensitivity analysis. Prostatectomy had the greatest net benefit (£290,487 [95% CI £280,781 to £296,281]) for men younger than 65 and radical radiotherapy (£201,311 [95% CI £195,161 to £205,049]) for men older than 65, but sensitivity analysis showed considerable uncertainty in both findings.Conclusion: Over the lifetime, extrapolating from the ProtecT trial, radical radiotherapy and prostatectomy appeared to be cost-effective for low risk prostate cancer, and radical prostatectomy for intermediate/high risk prostate cancer, but there was uncertainty in some estimates. Longer ProtecT trial follow-up is required to reduce uncertainty in the model.Trial Registration: Current Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014). [ABSTRACT FROM AUTHOR]

Published
2020
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40. 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 DE, Metcalfe C, Donovan JL, Lane JA, Davis M, Young GJ, Dutton SJ, Walsh EI, Martin RM, Peters TJ, Turner EL, Mason M, Bryant R, Bollina P, Catto J, Doherty A, Gillatt D, Gnanapragasam V, Holding P, Hughes O, Kockelbergh R, Kynaston H, Oxley J, Paul A, Paez E, Rosario DJ, Rowe E, Staffurth J, Altman DG, and Hamdy FC

Subjects
Aged, Disease Progression, Humans, Male, Middle Aged, Prostatectomy adverse effects, Prostatic Neoplasms pathology, Radiotherapy adverse effects, Radiotherapy methods, Time Factors, Treatment Outcome, Watchful Waiting, Prostatic Neoplasms mortality, Prostatic Neoplasms therapy
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 6mo) and urinary incontinence (55% at 6mo) after surgery, and of sexual dysfunction (88% at 6mo) and bowel dysfunction (5% at 6mo) 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 10yr, 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., (Copyright © 2019 The Author(s). Published by Elsevier B.V. All rights reserved.)

Published
2020
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41. CYP7B generates a selective estrogen receptor beta agonist in human prostate.

Author

Martin C, Ross M, Chapman KE, Andrew R, Bollina P, Seckl JR, and Habib FK

Subjects
Aged, Cells, Cultured, Dehydroepiandrosterone metabolism, Epithelial Cells cytology, Epithelial Cells physiology, Estrogen Receptor alpha, Estrogen Receptor beta, Gene Expression, Genes, Reporter, Humans, Immunohistochemistry, Male, Middle Aged, Prostate cytology, RNA, Messenger analysis, Receptors, Androgen metabolism, Receptors, Estrogen agonists, Stromal Cells cytology, Cytochrome P-450 Enzyme System genetics, Cytochrome P-450 Enzyme System metabolism, Prostate metabolism, Receptors, Estrogen metabolism, Steroid Hydroxylases genetics, Steroid Hydroxylases metabolism
Abstract

In human prostate, dehydroepiandrosterone (DHEA) is a substrate for two major metabolic pathways that produce functionally opposing sex steroids. In one pathway, DHEA is converted into potent androgens such as testosterone and 5alpha-dihydrotestosterone. In the other, DHEA is metabolized to 7alpha-hydroxy-DHEA (7HD). Recently, CYP7B, a novel P450 enzyme originally characterized in mouse brain and expressed in rodent prostate, has been found to be responsible for all extrahepatic 7alpha-hydroxylase activity. In this study, we have investigated the expression and function of this novel enzyme in human prostate. We have used reverse transcription combined with PCR and mRNA in situ hybridization to determine and localize the expression of CYP7B mRNA in human benign prostatic hyperplasia. High levels of CYP7B mRNA were localized in the epithelial cells together with estrogen receptor beta (ERbeta). 7alpha-Hydroxylation was the major metabolic fate of DHEA in human prostate. Furthermore, we have shown that human prostate epithelial cells in primary culture maintain a high level of 7alpha-hydroxylase activity, which was enhanced by coculture with stroma cells. To investigate the functional relevance of CYP7B expression to sex-steroid action in prostate, we used transient transfections and ligand binding assay to determine the ability of 7HD to bind and activate the sex-steroid receptors: androgen receptor, ERalpha, and ERbeta. 7HD specifically activates ERbeta-mediated transcription, mimicking the effects of 17beta-estradiol, but has no impact on ERalpha and androgen receptor. Given that DHEA, and its sulfate, circulate at micromolar concentrations, there is a clear possibility that CYP7B generates sufficient 7HD to activate ERbeta over and above that achieved with very low concentrations of intraprostatic 17beta-estradiol. In conclusion, our study suggests that CYP7B catalyzes oxysterol 7alpha-hydroxylation within the human prostate epithelium. By this reaction, an ERbeta-specific agonist, 7HD, is produced. Therefore, CYP7B may be a novel regulator of the androgens/estrogenic balance within the prostate.

Published
2004
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42. 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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