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1. Preparing for responsive management versus preparing for renal dialysis in multimorbid older people with advanced chronic kidney disease (Prepare for Kidney Care): Study protocol for a randomised controlled trial.

Author

Worthington, Jo, Soundy, Alexandra, Frost, Jessica, Rooshenas, Leila, MacNeill, Stephanie J., Realpe Rojas, Alba, Garfield, Kirsty, Liu, Yumeng, Alloway, Karen, Ben-Shlomo, Yoav, Burns, Aine, Chilcot, Joseph, Darling, Jos, Davies, Simon, Farrington, Ken, Gibson, Andrew, Husbands, Samantha, Huxtable, Richard, McNally, Helen, Murphy, Emma, Murtagh, Fliss E. M., Rayner, Hugh, Rice, Caoimhe T., Roderick, Paul, Salisbury, Chris, Taylor, Jodi, Winton, Helen, Donovan, Jenny, Coast, Joanna, Lane, J Athene, and Caskey, Fergus J.

Published
2024
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9. The high-volume haemodiafiltration vs high-flux haemodialysis registry trial (H4RT): a multi-centre, unblinded, randomised, parallel-group, superiority study to compare the effectiveness and cost-effectiveness of high-volume haemodiafiltration and high-flux haemodialysis in people with kidney failure on maintenance dialysis using linkage to routine healthcare databases for outcomes

Author

Caskey, Fergus J., Procter, Sunita, MacNeill, Stephanie J., Wade, Julia, Taylor, Jodi, Rooshenas, Leila, Liu, Yumeng, Annaw, Ammar, Alloway, Karen, Davenport, Andrew, Power, Albert, Farrington, Ken, Mitra, Sandip, Wheeler, David C., Law, Kristian, Lewis-White, Helen, Ben-Shlomo, Yoav, Hollingworth, Will, Donovan, Jenny, and Lane, J. Athene

Published
2022
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10. Prostate cancer–Exercise and Metformin Trial (Pre-EMpT): study protocol for a feasibility factorial randomized controlled trial in men with localised or locally advanced prostate cancer

Author

McGeagh, Lucy, Robles, Luke A., Persad, Raj, Rowe, Edward, Bahl, Amit, Aning, Jonathan, Koupparis, Anthony, Abrams, Paul, Perks, Claire, Holly, Jeffrey, Johnson, Lyndsey, Shiridzinomwa, Constance, Challapalli, Amarnath, Shingler, Ellie, Taylor, Hilary, Oxley, Jon, Sandu, Meda, Martin, Richard M., and Lane, J. Athene

Published
2022
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12. Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): a randomised controlled trial

Author

Beck, Rupert, Blake, Christopher, Davenport, Kim, Kayes, Oliver, Sullivan, Jonathan, Cohen, Nicholas, Murugesan, Mathialagan, Timoney, Anthony, Johnson, Lyndsey, Adams, Benita, Allan, Angela, Brain, Carol, Hammonds, Fiona, Henderson, Joan, Hilltout, Paula, Kilbane, Bernadette, Morrison, Leigh, Robson, Wendy, Wiseman, Lorraine, Zinyemba, Vivian, Metcalfe, Chris, Khan, Rafiyah, Uren, Alan, Ahern, Aideen, Moure Fernandez, Aida, Warnes, Barbara, Steuart-Feilding, Tom, Pawsey, Christopher, Plant, Julie, Baquedano, Mai, Carmichael, David, Hashim, Hashim, Worthington, Jo, Abrams, Paul, Young, Grace, Taylor, Hilary, Noble, Sian M, Brookes, Sara T, Cotterill, Nikki, Page, Tobias, Swami, K Satchi, and Lane, J Athene

Published
2020
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13. 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

Hamdy, Freddie C., Donovan, Jenny L., Neal, David E., Lane, J. Athene, Metcalfe, Chris, Peters, Tim J., Bollina, Prasad, Doble, Andrew, Doherty, Alan, Gnanapragasam, Vincent, Hughes, Owen, Gillatt, David, Kockelbergh, Roger, Kynaston, Howard, Paul, Alan, Paez, Edgar, Powell, Philip, Prescott, Stephen, Rosario, Derek, Rowe, Edward, Anderson, John B., Aning, Jonathan, Catto, James, 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, Holding, Peter, 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, Mason, Malcolm, 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, Staffurth, John, Symonds, Paul, Thanvi, Narottam, Vasanthan, Subramaniam, Wilson, Paula, Oxley, Jon, 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, Davis, Michael, Dedman, Dan, Down, Elizabeth, Khazragui, Hanan, Martin, Richard M., Noble, Sian, Taylor, Hilary, Tazewell, Marta, Turner, Emma L., 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, Young, Grace J., Dutton, Susan J., Walsh, Eleanor I., Peters, Tim. J., Bryant, Richard, Rosario, Derek J., and Altman, Doug G.

Published
2020
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14. 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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15. Clinical and Patient-reported Outcome Measures in Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms: Baseline Results and Diagnostic Findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM)

Author

Lewis, Amanda L., Young, Grace J., Abrams, Paul, Blair, Peter S., Chapple, Christopher, Glazener, Cathryn M.A., Horwood, Jeremy, McGrath, John S., Noble, Sian, Taylor, Gordon T., Ito, Hiroki, Belal, Mohammed, Davies, Melissa C., Dickinson, Andrew J., Foley, Charlotte L., Foley, Steve, Fulford, Simon, Gammal, Mohsen M., Garthwaite, Mary, Harris, Mark R.E., Ilie, Petre C., Jones, Robert, Sabbagh, Samer, Mason, Robert G., McLarty, Ester, Mishra, Vibhash, Mom, Jaswant, Morley, Roland, Natale, Salvatore, Nitkunan, Tharani, Page, Tobias, Payne, David, Rashid, Tina G., Saeb-Parsy, Kasra, Sandhu, Sarb S., Simoes, Adrian, Singh, Gurpreet, Sullivan, Mark, Tempest, Heidi V., Viswanath, Srinivasa, Walker, Roger M.H., Lane, J. Athene, and Drake, Marcus J.

Published
2019
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17. 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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21. Prostate-Specific Antigen Screening and 15-Year Prostate Cancer Mortality: A Secondary Analysis of the CAP Randomized Clinical Trial.

Author

Martin, Richard M., Turner, Emma L., Young, Grace J., Metcalfe, Chris, Walsh, Eleanor I., Lane, J. Athene, Sterne, Jonathan A. C., Noble, Sian, Holding, Peter, Ben-Shlomo, Yoav, Williams, Naomi J., Pashayan, Nora, Bui, Mai Ngoc, Albertsen, Peter C., Seibert, Tyler M., Zietman, Anthony L., Oxley, Jon, Adolfsson, Jan, Mason, Malcolm D., and Davey Smith, George

Abstract

This secondary analysis of a randomized clinical trial assesses whether screening for prostate-specific antigen reduces prostate cancer mortality at 15-year follow-up. Key Points: Question: In men aged 50 to 69 years, does a single invitation for a prostate-specific antigen (PSA) screening test reduce prostate cancer mortality at 15-year follow-up compared with no invitation for testing? Findings: In this secondary analysis of a randomized clinical trial of 415 357 men aged 50 to 69 years randomized to a single invitation for PSA screening (n = 195 912) or a control group without PSA screening (n = 219 445) and followed up for a median of 15 years, risk of death from prostate cancer was lower in the group invited to screening (0.69% vs 0.78%; mean difference, 0.09%) compared with the control group. Meaning: Compared with no invitation for routine PSA testing, a single invitation for a PSA screening test reduced prostate cancer mortality at a median follow-up of 15 years, but the absolute mortality benefit was small. Importance: The Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP) reported no effect of prostate-specific antigen (PSA) screening on prostate cancer mortality at a median 10-year follow-up (primary outcome), but the long-term effects of PSA screening on prostate cancer mortality remain unclear. Objective: To evaluate the effect of a single invitation for PSA screening on prostate cancer–specific mortality at a median 15-year follow-up compared with no invitation for screening. Design, Setting, and Participants: This secondary analysis of the CAP randomized clinical trial included men aged 50 to 69 years identified at 573 primary care practices in England and Wales. Primary care practices were randomized between September 25, 2001, and August 24, 2007, and men were enrolled between January 8, 2002, and January 20, 2009. Follow-up was completed on March 31, 2021. Intervention: Men received a single invitation for a PSA screening test with subsequent diagnostic tests if the PSA level was 3.0 ng/mL or higher. The control group received standard practice (no invitation). Main Outcomes and Measures: The primary outcome was reported previously. Of 8 prespecified secondary outcomes, results of 4 were reported previously. The 4 remaining prespecified secondary outcomes at 15-year follow-up were prostate cancer–specific mortality, all-cause mortality, and prostate cancer stage and Gleason grade at diagnosis. Results: Of 415 357 eligible men (mean [SD] age, 59.0 [5.6] years), 98% were included in these analyses. Overall, 12 013 and 12 958 men with a prostate cancer diagnosis were in the intervention and control groups, respectively (15-year cumulative risk, 7.08% [95% CI, 6.95%-7.21%] and 6.94% [95% CI, 6.82%-7.06%], respectively). At a median 15-year follow-up, 1199 men in the intervention group (0.69% [95% CI, 0.65%-0.73%]) and 1451 men in the control group (0.78% [95% CI, 0.73%-0.82%]) died of prostate cancer (rate ratio [RR], 0.92 [95% CI, 0.85-0.99]; P =.03). Compared with the control, the PSA screening intervention increased detection of low-grade (Gleason score [GS] ≤6: 2.2% vs 1.6%; P <.001) and localized (T1/T2: 3.6% vs 3.1%; P <.001) disease but not intermediate (GS of 7), high-grade (GS ≥8), locally advanced (T3), or distally advanced (T4/N1/M1) tumors. There were 45 084 all-cause deaths in the intervention group (23.2% [95% CI, 23.0%-23.4%]) and 50 336 deaths in the control group (23.3% [95% CI, 23.1%-23.5%]) (RR, 0.97 [95% CI, 0.94-1.01]; P =.11). Eight of the prostate cancer deaths in the intervention group (0.7%) and 7 deaths in the control group (0.5%) were related to a diagnostic biopsy or prostate cancer treatment. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, a single invitation for PSA screening compared with standard practice without routine screening reduced prostate cancer deaths at a median follow-up of 15 years. However, the absolute reduction in deaths was small. Trial Registration: isrctn.org Identifier: ISRCTN92187251 [ABSTRACT FROM AUTHOR]

Published
2024
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22. Mortality Among Men with Advanced Prostate Cancer Excluded from the ProtecT Trial

Author

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

Published
2017
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25. TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial

Author

Frost, Jessica, Lane, J. Athene, Cotterill, Nikki, Fader, Mandy, Hackshaw-McGeagh, Lucy, Hashim, Hashim, Macaulay, Margaret, MacNeill, Stephanie J., Noble, Sian, Rees, Jonathan, Ridd, Matthew J., Robles, Luke, Taylor, Gordon, Taylor, Jodi, Drake, Marcus J, and Worthington, Jo

Published
2019
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26. Lower urinary tract symptoms in men: the TRIUMPH cluster RCT.

Author

Worthington, Jo, Frost, Jessica, Sanderson, Emily, Cochrane, Madeleine, Wheeler, Jessica, Cotterill, Nikki, MacNeill, Stephanie J., Noble, Sian, Avery, Miriam, Clarke, Samantha, Fader, Mandy, Hashim, Hashim, McGeagh, Lucy, Macaulay, Margaret, Rees, Jonathan, Robles, Luke, Taylor, Gordon, Taylor, Jodi, Thompson, Joanne, and Lane, J. Athene

Published
2024

30. Treatment of lower urinary tract symptoms in men in primary care using a conservative intervention: cluster randomised controlled trial.

Author

Drake, Marcus J., Worthington, Jo, Frost, Jessica, Sanderson, Emily, Cochrane, Madeleine, Cotterill, Nikki, Fader, Mandy, McGeagh, Lucy, Hashim, Hashim, Macaulay, Margaret, Rees, Jonathan, Robles, Luke A., Taylor, Gordon, Taylor, Jodi, Ridd, Matthew J., MacNeill, Stephanie J., Noble, Sian, and Lane, J. Athene

Subjects
URINARY tract infection treatment, CONSERVATIVE treatment, CONFIDENCE intervals, URINARY tract infections, REGRESSION analysis, PRIMARY health care, TREATMENT effectiveness, RANDOMIZED controlled trials, NATIONAL health services, RESEARCH funding, HEALTH behavior, QUALITY of life, MEDICAL referrals, QUESTIONNAIRES, DESCRIPTIVE statistics, PATIENT education, ADVERSE health care events, BEHAVIOR modification, SYMPTOMS, EVALUATION
Published
2023
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45. Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment.

Author

Donovan, Jenny L., Hamdy, Freddie C., Lane, J. Athene, Young, Grace J., Metcalfe, Chris, Walsh, Eleanor I., Davis, Michael, Steuart-Feilding, Thomas, Blazeby, Jane M., Avery, Kerry N. L., Martin, Richard M., Bollina, Prasad, Doble, Andrew, Doherty, Alan, Gillatt, David, Gnanapragasam, Vincent, Hughes, Owen, Kockelbergh, Roger, Kynaston, Howard, and Paul, Alan

Subjects
TIME, AGE distribution, HEALTH outcome assessment, URINARY organ physiology, TREATMENT effectiveness, RANDOMIZED controlled trials, QUALITY of life, RESEARCH funding, STATISTICAL sampling, DECISION making in clinical medicine, STATISTICAL models, PROSTATE tumors, SEXUAL health, EVALUATION
Abstract

Background: Long-term patient-reported outcomes are needed to inform treatment decisions for localized prostate cancer. Methods: Patient-reported outcomes of 1643 randomly assigned participants in the ProtecT (Prostate Testing for Cancer and Treatment) trial were evaluated to assess the functional and quality-of-life impacts of prostatectomy, radiotherapy with neoadjuvant androgen deprivation, and active monitoring. This article focuses on the outcomes of the randomly assigned participants from 7 to 12 years using mixed effects linear and logistic models. Results: Response rates exceeded 80% for most measures. Among the randomized groups over 7 to 12 years, generic quality-of-life scores were similar. Among those in the prostatectomy group, urinary leakage requiring pads occurred in 18 to 24% of patients over 7 to 12 years, compared with 9 to 11% in the active monitoring group and 3 to 8% in the radiotherapy group. In the prostatectomy group, 18% reported erections sufficient for intercourse at 7 years, compared with 30% in the active monitoring and 27% in the radiotherapy groups; all converged to low levels of potency by year 12. Nocturia (voiding at least twice per night) occurred in 34% in the prostatectomy group compared with 48% in the radiotherapy group and 47% in the active monitoring group at 12 years. Fecal leakage affected 12% in the radiotherapy group compared with 6% in the other groups by year 12. The active monitoring group experienced gradual age-related declines in sexual and urinary function, avoiding radical treatment effects unless they changed management. Conclusions: ProtecT provides robust evidence about continued impacts of treatments in the long term. These data allow patients newly diagnosed with localized prostate cancer and their clinicians to assess the trade-offs between treatment harms and benefits and enable better informed and prudent treatment decisions. (Funded by the UK National Institute for Health and Care Research Health Technology Assessment Programme projects 96/20/06 and 96/20/99; ISRCTN number, ISRCTN20141297; ClinicalTrials.gov number, NCT02044172.) [ABSTRACT FROM AUTHOR]

Published
2023
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