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3. European Association of Urology Guidelines on Upper Urinary Tract Urothelial Carcinoma: 2023 Update

Author

Rouprêt, Morgan, Seisen, Thomas, Birtle, Alison J., Capoun, Otakar, Compérat, Eva M., Dominguez-Escrig, José L., Gürses Andersson, Irene, Liedberg, Fredrik, Mariappan, Paramananthan, Hugh Mostafid, A., Pradere, Benjamin, van Rhijn, Bas W.G., Shariat, Shahrokh F., Rai, Bhavan P., Soria, Francesco, Soukup, Viktor, Wood, Robbert G., Xylinas, Evanguelos N., Masson-Lecomte, Alexandra, and Gontero, Paolo

Published
2023
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4. Addition of nintedanib or placebo to neoadjuvant gemcitabine and cisplatin in locally advanced muscle-invasive bladder cancer (NEOBLADE): a double-blind, randomised, phase 2 trial

Author

Hussain, Syed A, Lester, Jason F, Jackson, Richard, Gornall, Matthew, Qureshi, Muneeb, Elliott, Anthony, Crabb, Simon J, Huddart, Robert A, Vasudev, Naveen, Birtle, Alison J, Worlding, Jane, James, Nicholas D, Parikh, Omi, Vilarino-Varela, Maria, Alonzi, Roberto, Linch, Mark D, Riaz, Irbaz B, Catto, James W F, Powles, Thomas, and Jones, Robert J

Published
2022
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5. Addition of Docetaxel to First-line Long-term Hormone Therapy in Prostate Cancer (STAMPEDE): Modelling to Estimate Long-term Survival, Quality-adjusted Survival, and Cost-effectiveness

Author

Woods, Beth S., Sideris, Eleftherios, Sydes, Matthew R., Gannon, Melissa R., Parmar, Mahesh K.B., Alzouebi, Mymoona, Attard, Gerhardt, Birtle, Alison J., Brock, Susannah, Cathomas, Richard, Chakraborti, Prabir R., Cook, Audrey, Cross, William R., Dearnaley, David P., Gale, Joanna, Gibbs, Stephanie, Graham, John D., Hughes, Robert, Jones, Rob J., Laing, Robert, Mason, Malcolm D., Matheson, David, McLaren, Duncan B., Millman, Robin, O'Sullivan, Joe M., Parikh, Omi, Parker, Christopher C., Peedell, Clive, Protheroe, Andrew, Ritchie, Alastair W.S., Robinson, Angus, Russell, J. Martin, Simms, Matthew S., Srihari, Narayanan N., Srinivasan, Rajaguru, Staffurth, John N., Sundar, Santhanam, Thalmann, George N., Tolan, Shaun, Tran, Anna T.H., Tsang, David, Wagstaff, John, James, Nicholas D., and Sculpher, Mark J.

Published
2018
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6. Results of the FLAC European Database of Metastatic Castration-Resistant Prostate Cancer Patients Treated With Docetaxel, Cabazitaxel, and Androgen Receptor–Targeted Agents

Author

Angelergues, Antoine, Efstathiou, Eleni, Gyftaki, Revekka, Wysocki, Piotr Jan, Lainez, Nuria, Gonzalez, Iria, Castellano, Daniel E., Ozguroglu, Mustafa, Carbonero, Iciar Garcia, Flechon, Aude, Borrega, Pablo, Guillot, Aline, Balea, Begona Campos, Le Moulec, Sylvestre, Esteban, Emilio, Munarriz, Javier, Rubio, Gustavo, Birtle, Alison J., Delanoy, Nicolas, Bellmunt, Joaquim, and Oudard, Stéphane

Published
2018
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7. Diagnosis, treatment and survival from bladder, upper urinary tract, and urethral cancers: real‐world findings from NHS England between 2013 and 2019

Author

Catto, James W.F., primary, Mandrik, Olena, additional, Quayle, Lewis A., additional, Hussain, Syed A., additional, McGrath, John, additional, Cresswell, Joanne, additional, Birtle, Alison J., additional, Jones, Rob J., additional, Mariappan, Paramananthan, additional, Makaroff, Lydia E., additional, Knight, Allen, additional, Mostafid, Hugh, additional, Chilcott, Jim, additional, Sasieni, Peter, additional, and Cumberbatch, Marcus, additional

Published
2023
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8. Diagnosis, treatment and survival from bladder, upper urinary tract and urethral cancers: Real world findings from NHS England between 2013 and 2019

Author

Catto, James W F, Mandrik, Olena, Quayle, Lewis A, Hussain, Syed A, McGrath, John, Cresswell, Joanne, Birtle, Alison J, Jones, Rob J, Mariappan, Paramananthan, Makaroff, Lydia E, Knight, Allen, Mostafid, Hugh, Chilcott, Jim, Sasieni, Peter, Cumberbatch, Marcus, Catto, James W F, Mandrik, Olena, Quayle, Lewis A, Hussain, Syed A, McGrath, John, Cresswell, Joanne, Birtle, Alison J, Jones, Rob J, Mariappan, Paramananthan, Makaroff, Lydia E, Knight, Allen, Mostafid, Hugh, Chilcott, Jim, Sasieni, Peter, and Cumberbatch, Marcus

Abstract

Objective We report NHS England data for patients with bladder cancer (BC), upper tract urothelial cancer (UTUC: renal pelvic and ureteric), and urethral cancers from 2013 to 2019. Materials and Methods Hospital episode statistics, waiting times, and cancer registrations were extracted from NHS Digital. Results Registrations included 128 823 individuals with BC, 16 018 with UTUC, and 2533 with urethral cancer. In 2019, 150 816 persons were living with a diagnosis of BC, of whom 113 067 (75.0%) were men, 85 117 (56.5%) were aged >75 years, and 95 553 (91.7%) were Caucasian. Incidence rates were stable (32.7–34.3 for BC, 3.9–4.2 for UTUC and 0.6–0.7 for urethral cancer per 100 000 population). Most patients 52 097 (mean [range] 41.3% [40.7–42.0%]) were referred outside the 2-week-wait pathway and 15 340 (mean [range] 12.2% [11.7–12.6%]) presented as emergencies. Surgery, radiotherapy, chemotherapy, or multimodal treatment use varied with disease stage, patient factors and Cancer Alliance. Between 27% and 29% (n = 6616) of muscle-invasive BCs did not receive radical treatment. Survival rates reflected stage, grade, location, and tumour histology. Overall survival rates did not improve over time (relative change: 0.97, 95% confidence interval 0.97–0.97) at 2 years in contrast to other cancers. Conclusion The diagnostic pathway for BC needs improvement. Increases in survival might be delivered through greater use of radical treatment. NHS Digital data offers a population-wide picture of this disease but does not allow individual outcomes to be matched with disease or patient features and key parameters can be missing or incomplete.

Published
2023

9. Diagnosis, treatment and survival from bladder, upper urinary tract and urethral cancers: Real world findings from NHS England between 2013 and 2019

Author

Catto, James W.F., Mandrik, Olena, Quayle, Lewis A., Hussain, Syed A., McGrath, John, Cresswell, Joanne, Birtle, Alison J, Jones, Rob J., Mariappan, Paramananthan, Makaroff, Lydia E., Knight, Allen, Mostafid, Hugh, Chilcott, Jim, Sasieni, Peter, Cumberbatch, Marcus, Catto, James W.F., Mandrik, Olena, Quayle, Lewis A., Hussain, Syed A., McGrath, John, Cresswell, Joanne, Birtle, Alison J, Jones, Rob J., Mariappan, Paramananthan, Makaroff, Lydia E., Knight, Allen, Mostafid, Hugh, Chilcott, Jim, Sasieni, Peter, and Cumberbatch, Marcus

Abstract

Objective We report NHS England data for patients with bladder cancer (BC), upper tract urothelial (UTUC: renal pelvic and ureteric) and urethral cancers from 2013 to 2019. Materials and methods Hospital episode statistics, waiting times and cancer registrations were extracted from NHS Digital. Results Registrations included 128,823 individuals with BC, 16,018 with UTUC and 2,533 with urethral cancer. In 2019, 150,816 persons were living with a diagnosis of BC, of whom 113,067 (75.0%) were men, 85,117 (56.5%) aged over 75 yrs, and 95,553 (91.7%) Caucasian. Incidence rates were stable (32.7-34.3 for BC, 3.9-4.2 for UTUC and 0.6-0.7 for urethral cancer per 100,000 population). Most patients (52,097 (41.3% (40.7-42.0%)) were referred outside the two week wait pathway and 15,340 (12.2% (11.7-12.6%)) presented as emergencies. Surgery, radiotherapy, chemotherapy or multimodal treatment use varied with disease stage, patient factors and Cancer Alliance. Between 27-29% (6,616) of muscle-invasive BCs did not receive radical treatment. Survival rates reflected stage, grade, location and tumour histology. Overall survival rates did not improve over time (relative change: 0.97 (95%CI: 0.97-0.97) at 2 years) in contrast to other cancers. Conclusion The diagnostic pathway for BC needs improvement. Increases in survival might be delivered through greater use in radical treatment. NHS Digital data offers a population-wide picture of this disease but does not allow individual outcomes to be matched with disease or patient features and key parameters can be missing or incomplete.

Published
2023

10. Development and Validation of Consensus Contouring Guidelines for Adjuvant Radiation Therapy for Bladder Cancer After Radical Cystectomy

Author

Baumann, Brian C., Bosch, Walter R., Bahl, Amit, Birtle, Alison J., Breau, Rodney H., Challapalli, Amarnath, Chang, Albert J., Choudhury, Ananya, Daneshmand, Sia, El-Gayed, Ali, Feldman, Adam, Finkelstein, Steven E., Guzzo, Thomas J., Hilman, Serena, Jani, Ashesh, Malkowicz, S. Bruce, Mantz, Constantine A., Master, Viraj, Mitra, Anita V., Murthy, Vedang, Porten, Sima P., Richaud, Pierre M., Sargos, Paul, Efstathiou, Jason A., Eapen, Libni J., and Christodouleas, John P.

Published
2016
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11. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial

Author

James, Nicholas D, Sydes, Matthew R, Clarke, Noel W, Mason, Malcolm D, Dearnaley, David P, Spears, Melissa R, Ritchie, Alastair W S, Parker, Christopher C, Russell, J Martin, Attard, Gerhardt, de Bono, Johann, Cross, William, Jones, Rob J, Thalmann, George, Amos, Claire, Matheson, David, Millman, Robin, Alzouebi, Mymoona, Beesley, Sharon, Birtle, Alison J, Brock, Susannah, Cathomas, Richard, Chakraborti, Prabir, Chowdhury, Simon, Cook, Audrey, Elliott, Tony, Gale, Joanna, Gibbs, Stephanie, Graham, John D, Hetherington, John, Hughes, Robert, Laing, Robert, McKinna, Fiona, McLaren, Duncan B, O'Sullivan, Joe M, Parikh, Omi, Peedell, Clive, Protheroe, Andrew, Robinson, Angus J, Srihari, Narayanan, Srinivasan, Rajaguru, Staffurth, John, Sundar, Santhanam, Tolan, Shaun, Tsang, David, Wagstaff, John, and Parmar, Mahesh K B

Published
2016
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12. A Randomized, Double-Blind, Biomarker-Selected, Phase II Clinical Trial of Maintenance Poly ADP-Ribose Polymerase Inhibition With Rucaparib Following Chemotherapy for Metastatic Urothelial Carcinoma

Author

Crabb, Simon J., primary, Hussain, Syed, additional, Soulis, Eileen, additional, Hinsley, Samantha, additional, Dempsey, Laura, additional, Trevethan, Avril, additional, Song, YeePei, additional, Barber, Jim, additional, Frew, John, additional, Gale, Joanna, additional, Faust, Guy, additional, Brock, Susannah, additional, McGovern, Ursula, additional, Parikh, Omi, additional, Enting, Deborah, additional, Sundar, Santhanam, additional, Ratnayake, Gihan, additional, Lees, Kathryn, additional, Birtle, Alison J., additional, Powles, Thomas, additional, and Jones, Robert J., additional

Published
2023
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13. Overall Survival Update for Patients with Metastatic Castration-resistant Prostate Cancer Treated with Capivasertib and Docetaxel in the Phase 2 ProCAID Clinical Trial

Author

Crabb, Simon J., primary, Griffiths, Gareth, additional, Dunkley, Denise, additional, Downs, Nichola, additional, Ellis, Mary, additional, Radford, Mike, additional, Light, Michelle, additional, Northey, Josh, additional, Whitehead, Amy, additional, Wilding, Sam, additional, Birtle, Alison J., additional, Khoo, Vincent, additional, and Jones, Robert J., additional

Published
2022
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15. A randomized, double-blind, biomarker-selected, phase ii clinical trial of maintenance poly adp-ribose polymerase inhibition with rucaparib following chemotherapy for metastatic urothelial carcinoma

Author

Crabb, Simon J., Hussain, Syed, Soulis, Eileen, Hinsley, Samantha, Dempsey, Laura, Trevethan, Avril, Song, YeePe, Barber, Jim, Frew, John, Gale, Joanna, Faust, Guy, Brock, Susannah, McGovern, Ursula, Parikh, Omi, Enting, Deborah, Sundar, Santhanam, Ratnayake, Gihan, Lees, Kathryn, Birtle, Alison J., Powles, Thomas, and Jones, Robert J.

Abstract

PURPOSE:\ud A DNA repair deficiency (DRD) phenotype exists within a subset of metastatic urothelial carcinomas (mUC) predicting benefit from platinum-based chemotherapy. We tested switch maintenance therapy with the poly ADP-ribose polymerase inhibitor rucaparib, following chemotherapy, for DRD biomarker–positive mUC.\ud \ud METHODS:\ud DRD biomarker–positive mUC patients, within 10 weeks of chemotherapy, and without cancer progression, were randomly assigned (1:1) to maintenance rucaparib 600 mg twice a day orally, or placebo, until disease progression. The primary end point was progression-free survival (PFS). Statistical analysis targeted a hazard ratio of 0.5 with a 20% one-sided α for this signal-seeking trial. PFS (RECIST 1.1) was compared between trial arms, by intention to treat, within a Cox model.\ud \ud RESULTS:\ud Out of 248 patients, 74 (29.8%) were DRD biomarker–positive and 40 were randomly assigned. A total of 12 (60%) and 20 (100%) PFS events occurred in the rucaparib and placebo arms, respectively (median follow-up was 94.6 weeks in those still alive). Median PFS was 35.3 weeks (80% CI, 11.7 to 35.6) with rucaparib and 15.1 weeks (80% CI, 11.9 to 22.6) with placebo (hazard ratio, 0.53; 80% CI, 0.30 to 0.92; one-sided P = .07). In the safety population (n = 39) treatment-related adverse events were mostly low grade. Patients received a median duration of 10 rucaparib or six placebo cycles on treatment. Treatment-related adverse events (all grades) of fatigue (63.2% v 30.0%), nausea (36.8% v 5.0%), rash (21.1% v 0%), and raised alanine aminotransferase (57.9% v 10%) were more common with rucaparib.\ud \ud CONCLUSION:\ud Maintenance rucaparib, following platinum-based chemotherapy, extended PFS in DRD biomarker-selected patients with mUC and was tolerable. Further investigation of poly ADP-ribose polymerase inhibition in selected patients with mUC is warranted.

Published
2022

16. Docetaxel for Nonmetastatic Prostate Cancer: Long-Term Survival Outcomes in the STAMPEDE Randomized Controlled Trial

Author

James, Nicholas D, primary, Ingleby, Fiona C, additional, Clarke, Noel W, additional, Amos, Claire L, additional, Attard, Gerhardt, additional, Brawley, Christopher D, additional, Chowdhury, Simon, additional, Cross, William, additional, Dearnaley, David P, additional, Gilbert, Duncan C, additional, Gillessen, Silke, additional, Jones, Robert J, additional, Langley, Ruth E, additional, Macnair, Archie, additional, Malik, Zafar I, additional, Mason, Malcolm D, additional, Matheson, David J, additional, Millman, Robin, additional, Parker, Chris C, additional, Rush, Hannah L, additional, Russell, J Martin, additional, Au, Carly, additional, Ritchie, Alastair W S, additional, Mestre, Ricardo Pereira, additional, Ahmed, Imtiaz, additional, Birtle, Alison J, additional, Brock, Susannah J, additional, Das, Prantik, additional, Ford, Victoria A, additional, Gray, Emma K, additional, Hughes, Robert J, additional, Manetta, Caroline B, additional, McLaren, Duncan B, additional, Nikapota, Ashok D, additional, O’Sullivan, Joe M, additional, Perna, Carla, additional, Peedell, Clive, additional, Protheroe, Andrew S, additional, Sundar, Santhanam, additional, Tanguay, Jacob S, additional, Tolan, Shaun P, additional, Wagstaff, John, additional, Wallace, Jan B, additional, Wylie, James P, additional, Zarkar, Anjali, additional, Parmar, Mahesh K B, additional, and Sydes, Matthew R, additional

Published
2022
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17. Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5‐year follow‐up results from the STAMPEDE randomised trial (NCT00268476)

Author

James, Nicholas D., Clarke, Noel W., Cook, Adrian, Ali, Adnan, Hoyle, Alex P., Attard, Gert, Brawley, Chris D., Chowdhury, Simon, Cross, William R., Dearnaley, David P., Bono, Johann S., Montana, Carlos Diaz, Gilbert, Duncan, Gillessen, Silke, Gilson, Clare, Jones, Rob J., Langley, Ruth E., Malik, Zafar I., Matheson, David J., Millman, Robin, Parker, Chris C., Pugh, Cheryl, Rush, Hannah, Russell, J. Martin, Berthold, Dominic R., Buckner, Michelle L., Mason, Malcolm D., Ritchie, Alastair W.S., Birtle, Alison J., Brock, Susannah J., Das, Prantik, Ford, Dan, Gale, Joanna, Grant, Warren, Gray, Emma K., Hoskin, Peter, Khan, Mohammad M., Manetta, Caroline, McPhail, Neil J., O'Sullivan, Joe M., Parikh, Omi, Perna, Carla, Pezaro, Carmel J., Protheroe, Andrew S., Robinson, Angus J., Rudman, Sarah M., Sheehan, Denise J., Srihari, Narayanan N., Syndikus, Isabel, Tanguay, Jacob, Thomas, Carys W., Vengalil, Salil, Wagstaff, John, Wylie, James P., Parmar, Mahesh K.B., and Sydes, Matthew R.

Subjects
Male, Cancer Research, Prednisolone, Abiraterone Acetate, Prostatic Neoplasms, Androgen Antagonists, B700, Hormones, Prostatic Neoplasms, Castration-Resistant, Treatment Outcome, Oncology, SDG 3 - Good Health and Well-being, Antineoplastic Combined Chemotherapy Protocols, Humans, Prednisone, Aged, Follow-Up Studies, Retrospective Studies
Abstract

Abiraterone acetate plus prednisolone (AAP) previously demonstrated improved survival in STAMPEDE, a multi-arm, multi-stage platform trial in men starting long-term hormone therapy for prostate cancer. This long-term analysis in metastatic patients was planned for 3 yrs after the first results. Standard-of-care (SOC) was androgen deprivation therapy. The comparison randomized patients 1:1 to SOC-alone with or without daily abiraterone acetate 1000 mg + prednisolone 5 mg (SOC + AAP), continued until disease progression. The primary outcome measure was overall survival. Metastatic disease risk group was classified retrospectively using baseline CT and bone scans by central radiological review and pathology reports. Analyses used Cox proportional hazards & flexible parametric models, adjusted for baseline stratification factors. 1003 patients were contemporaneously randomized (Nov-2011--Jan-2014): median age 67 yr; 94% newly-diagnosed; metastatic disease risk group: 48% high, 44% low, 8% un-assessable; median PSA 97 ng/mL. At 6.1 yr median follow-up, 329 SOC-alone deaths (118 low-risk, 178 high-risk) and 244 SOC + AAP deaths (75 low-risk, 145 high-risk) were reported. Adjusted HR = 0·60 (95%CI:0·50—0·71; P = 0.31x10−9) favoured SOC + AAP, with 5-yr survival improved from 41% SOC-alone to 60% SOC + AAP. This was similar in low-risk (HR = 0·55; 95%CI:0·41—0·76) and high-risk (HR = 0·54; 95%CI:0·43—0·69) patients. Median and current maximum time on SOC + AAP was 2.4 yr and 8.1 yr. Toxicity at 4 yr post-randomisation was similar, with 16% patients in each group reporting grade 3 or higher toxicity. A sustained and substantial improvement in overall survival of all metastatic prostate cancer patients was achieved with SOC + abiraterone acetate + prednisolone, irrespective of metastatic disease risk group.\ud \ud This article is protected by copyright. All rights reserved.

Published
2022

18. Overall Survival Update for Patients with Metastatic Castration-resistant Prostate Cancer Treated with Capivasertib and Docetaxel in the Phase 2 ProCAID Clinical Trial

Author

Crabb, Simon J., Griffiths, Gareth, Dunkley, Denise, Downs, Nichola, Ellis, Mary, Radford, Mike, Light, Michelle, Northey, Josh, Whitehead, Amy, Wilding, Sam, Birtle, Alison J., Khoo, Vincent, Jones, Robert J., Crabb, Simon J., Griffiths, Gareth, Dunkley, Denise, Downs, Nichola, Ellis, Mary, Radford, Mike, Light, Michelle, Northey, Josh, Whitehead, Amy, Wilding, Sam, Birtle, Alison J., Khoo, Vincent, and Jones, Robert J.

Abstract

The PI3K/AKT/PTEN pathway is frequently deregulated in metastatic castration-resistant prostate cancer (mCRPC). ProCAID was a phase 2 trial assessing addition of the AKT1/2/3 inhibitor capivasertib to docetaxel for patients with mCRPC. We previously reported that capivasertib did not extend a composite progression-free survival primary endpoint but did significantly improve the secondary endpoint of overall survival (OS). Here we present OS data after 66% of events had occurred in the intent-to-treat population (n = 150). Median OS was 25.3 mo for capivasertib plus docetaxel versus 20.3 mo for placebo plus docetaxel (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.47–1.05; nominal p = 0.09). Receipt of subsequent life-extending treatments was balanced between the treatment arms. The OS benefit associated with capivasertib was maintained in a subset of patients previously treated with abiraterone and/or enzalutamide (median OS 25.0 vs 17.6 mo; HR 0.57, 95% CI 0.36–0.91; nominal p = 0.02) but not in abiraterone/enzalutamide-naïve patients (median OS 31.1 mo vs not reached; HR 1.43, 95% CI 0.63–3.23). We conclude that OS may be extended by addition of capivasertib to docetaxel. Exploratory analysis revealed that the OS benefit was maintained in a subset of patients previously exposed to androgen receptor–targeted agents, which should be evaluated in prospective trials. Patient summary The ProCAID study examined whether adding the AKT inhibitor drug capivasertib to docetaxel chemotherapy improves outcomes for patients with advanced prostate cancer. Initial analysis of the ProCAID results suggested that capivasertib improved overall survival benefit. This follow-up analysis suggests that capivasertib addition may be particularly beneficial for patients whose cancer was previously treated with drugs that target the androgen receptor.

Published
2022

19. Celecoxib plus hormone therapy versus hormone therapy alone for hormone-sensitive prostate cancer: first results from the STAMPEDE multiarm, multistage, randomised controlled trial

Author

James, Nicholas D, Sydes, Matthew R, Mason, Malcolm D, Clarke, Noel W, Anderson, John, Dearnaley, David P, Dwyer, John, Jovic, Gordana, Ritchie, Alastair WS, Russell, J Martin, Sanders, Karen, Thalmann, George N, Bertelli, Gianfilippo, Birtle, Alison J, O'Sullivan, Joe M, Protheroe, Andrew, Sheehan, Denise, Srihari, Narayanan, and Parmar, Mahesh KB

Published
2012
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22. Pan-AKT Inhibitor Capivasertib With Docetaxel and Prednisolone in Metastatic Castration-Resistant Prostate Cancer: A Randomized, Placebo-Controlled Phase II Trial (ProCAID)

Author

Crabb, Simon J., primary, Griffiths, Gareth, additional, Marwood, Ellice, additional, Dunkley, Denise, additional, Downs, Nichola, additional, Martin, Karen, additional, Light, Michelle, additional, Northey, Josh, additional, Wilding, Sam, additional, Whitehead, Amy, additional, Shaw, Emily, additional, Birtle, Alison J., additional, Bahl, Amit, additional, Elliott, Tony, additional, Westbury, Charlotte, additional, Sundar, Santhanam, additional, Robinson, Angus, additional, Jagdev, Satinder, additional, Kumar, Satish, additional, Rooney, Claire, additional, Salinas-Souza, Carolina, additional, Stephens, Christine, additional, Khoo, Vincent, additional, and Jones, Robert J., additional

Published
2021
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28. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial

Author

Cook, Audrey, Beesley, Sharon, O'Sullivan, Joe M, Birtle, Alison J, Thalmann, George, Graham, John D, Spears, Melissa R, Brock, Susannah, Srinivasan, Rajaguru, Protheroe, Andrew, Sydes, Matthew R, Laing, Robert, Cross, William, Matheson, David, Tsang, David, Parmar, Mahesh K B, Sundar, Santhanam, McKinna, Fiona, Parikh, Omi, Chowdhury, Simon, Robinson, Angus J, De Bono, Johann, Elliott, Tony, Mason, Malcolm D, Parker, Christopher C, Alzouebi, Mymoona, Gibbs, Stephanie, Dearnaley, David P, Millman, Robin, Russell, J Martin, Tolan, Shaun, Chakraborti, Prabir, Cathomas, Richard, Srihari, Narayanan, Clarke, Noel W, Peedell, Clive, James, Nicholas D, Staffurth, John, Gale, Joanna, Hetherington, John, Amos, Claire, Attard, Gerhardt, Hughes, Robert, Jones, Rob J, Ritchie, Alastair W S, McLaren, Duncan B, Wagstaff, John, STAMPEDE investigators, Adab, F., Adeyoju, A., Ahmed, I., Alcock, C., Al-hasso, A., Alonzi, R., Alzouebi, M., Andrade, G., Andrews, S., Ansari, J., Anyamene, N., Azzabi, A., Bahl, A., Ballesteros-Quintail, D., Banerjee, G., Barber, J., Baria, K., Beaney, R., Beesley, S., Beresford, M., Bertelli, G., Bhalla, N., Bhana, R., Birtle, A., Bloomfield, D., Bowen, J., Brady, J., Brierly, R., Brock, S., Brown Richard, B., Brown, S., Button, M., Camilleri, P., Capaldi, L., Castell, F., Chadwick, E., Chakraborti, P., Chan, A., Chan, O., Charnley, N., Chetiyawardana, S., Choudhurey, A., Choudhury, A., Chowdhury, S., Churn, M., Clarke, A., Clarke, N., David, J.C., Cook, A., Cowan, R., Crabb, S., Crawford, M., Crellin, P., Cross, W., Das, T., Davies, J., Dearnaley, D., Dickson, J., Durrani, S., Edwards, A., Eichholz, A., Elliott, T., Eswar, C., Falconer, A., Ferguson, C., Ford, D., Ford, V., Frew, J., Frim, O., Gale, J., Gibbs, S., Glen, H., Graham, J.D., Grant, W., Gray, E., Guerrero-Urbano, T., Gupta, N., Hamid, A., Hamilton, J., Hardman, J., Harland, S., Harper, P., Heath, C., Henry, A., Herbert, C., Hetherington, J., Hill, E., Hilman, S., Hingorani, M., Hofmann, U., Hoskin, P., Huddart, R., Hughes, R., Hughes, S., Ibrahim, A., Jain, S., James, N., Jenkins, P., Jones, R., Kagzi, M., Karp, S., Kehagioglou, P., Kelly, K., Koh, P.K., Keni, M., Khaksar, S., Khan, O., Khoo, V., Kirkbride, P., Kumar, A., Kumar, M., Kumar, S., Laing, R., Lamb, C., Lau, M., Lees, K., Leone, P., Lester, J., Littler, J., Livsey, J., Logue, J., Loughrey, C., Lydon, A., Macgregor, C., Maddineni, S., Mahmood, R., Malik, Z., Mangar, S., Mason, M., Mazhar, D., McGovern, U., McKinna, F., McLaren, D., McMenemin, R., McPhail, N., Melcher, L., Mills, J., Mitchell, D., Mithal, N., Money-Kyrle, J., Montazeri, A., Morris, S., Mort, D., Mukhopadhyay, T., Muthukumar, D., Neave, F., Newby, J., Newman, H., Nicoll, J., Nikapota, A., O'Donnell, H., Ostler, P., O'Sullivan, J., Palaniappan, N., Panades, M., Pantelides, M., Panwar, U., Parikh, O., Parker, C.C., Pattu, P., Paul, A., Payne, H., Pedley, I., Peedell, C., Mau, D.P., Pickering, L., Pigott, K., Plataniotis, G., Popert, R., Porfiri, E., Prashant, R., Prescott, S., Protheroe, A., Pudney, D., Pwint, T., Ramachandra, P., Raman, R., Rimmer, Y., Robinson, A.J., Robson, P., Rogers, P., Russell, M., Sabharwal, A., Sadozye, A., Sangar, V., Sarwar, N., Saunders, D., Sayers, I., Scrase, C., Sentamans, C., Shaffer, R., Shakespeare, D., Sheehan, D., Poh, L.S., Sidek, N., Simms, M., Sivapalasuntharam, A., Sizer, B., Smith-Howell, M., Sparrow, G., Sreenivasan, T., Srihari, N., Srinivasan, R., Staffurth, J., Stewart, D., Stewart, S., Stockdale, A., Subramaniam, R., Sundar, S., Syndikus, I., Tanguay, J., Taylor, H., Thomas, C., Thompson, A., Tipples, K., Tolan, S., Tran, A., Tsang, D., Van der Voet, H., Varela Maria, V., Varughese, M., Venkitaraman, R., Venugopal, B., Wagstaff, J., Walker, G., Wallace, J., Wells, P., Westbury, C., Wheater, M., Whelan, P., Wilkins, M., Wilson, P., Wise, M., Wood, K., Woodward, C., Worlding, J., Wylie, J., Zarkar, A., Berthold, D., Cathomas, R., Durr, D., Engeler, D., Herrera, F., Jichlinski, P., Popescu, R., Prensser, S., Rentsch, C., Roth, B., Seifest, B., Siciliano, D., Strebel, R., and Thalmann, G.

Subjects
RC0254, Medicine(all), SDG 3 - Good Health and Well-being, 610 Medicine & health, Adult, Aged, Aged, 80 and over, Androgen Antagonists/administration & dosage, Androgen Antagonists/adverse effects, Antineoplastic Agents, Hormonal/administration & dosage, Antineoplastic Agents, Hormonal/adverse effects, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Diphosphonates/administration & dosage, Diphosphonates/adverse effects, Disease Progression, Docetaxel, Drug Administration Schedule, Humans, Imidazoles/administration & dosage, Imidazoles/adverse effects, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasm Metastasis, Prostatic Neoplasms/drug therapy, Taxoids/administration & dosage, Taxoids/adverse effects, Treatment Outcome, Zoledronic Acid
Abstract

BACKGROUND: Long-term hormone therapy has been the standard of care for advanced prostate cancer since the 1940s. STAMPEDE is a randomised controlled trial using a multiarm, multistage platform design. It recruits men with high-risk, locally advanced, metastatic or recurrent prostate cancer who are starting first-line long-term hormone therapy. We report primary survival results for three research comparisons testing the addition of zoledronic acid, docetaxel, or their combination to standard of care versus standard of care alone.METHODS: Standard of care was hormone therapy for at least 2 years; radiotherapy was encouraged for men with N0M0 disease to November, 2011, then mandated; radiotherapy was optional for men with node-positive non-metastatic (N+M0) disease. Stratified randomisation (via minimisation) allocated men 2:1:1:1 to standard of care only (SOC-only; control), standard of care plus zoledronic acid (SOC + ZA), standard of care plus docetaxel (SOC + Doc), or standard of care with both zoledronic acid and docetaxel (SOC + ZA + Doc). Zoledronic acid (4 mg) was given for six 3-weekly cycles, then 4-weekly until 2 years, and docetaxel (75 mg/m(2)) for six 3-weekly cycles with prednisolone 10 mg daily. There was no blinding to treatment allocation. The primary outcome measure was overall survival. Pairwise comparisons of research versus control had 90% power at 2·5% one-sided α for hazard ratio (HR) 0·75, requiring roughly 400 control arm deaths. Statistical analyses were undertaken with standard log-rank-type methods for time-to-event data, with hazard ratios (HRs) and 95% CIs derived from adjusted Cox models. This trial is registered at ClinicalTrials.gov (NCT00268476) and ControlledTrials.com (ISRCTN78818544).FINDINGS: 2962 men were randomly assigned to four groups between Oct 5, 2005, and March 31, 2013. Median age was 65 years (IQR 60-71). 1817 (61%) men had M+ disease, 448 (15%) had N+/X M0, and 697 (24%) had N0M0. 165 (6%) men were previously treated with local therapy, and median prostate-specific antigen was 65 ng/mL (IQR 23-184). Median follow-up was 43 months (IQR 30-60). There were 415 deaths in the control group (347 [84%] prostate cancer). Median overall survival was 71 months (IQR 32 to not reached) for SOC-only, not reached (32 to not reached) for SOC + ZA (HR 0·94, 95% CI 0·79-1·11; p=0·450), 81 months (41 to not reached) for SOC + Doc (0·78, 0·66-0·93; p=0·006), and 76 months (39 to not reached) for SOC + ZA + Doc (0·82, 0·69-0·97; p=0·022). There was no evidence of heterogeneity in treatment effect (for any of the treatments) across prespecified subsets. Grade 3-5 adverse events were reported for 399 (32%) patients receiving SOC, 197 (32%) receiving SOC + ZA, 288 (52%) receiving SOC + Doc, and 269 (52%) receiving SOC + ZA + Doc.INTERPRETATION: Zoledronic acid showed no evidence of survival improvement and should not be part of standard of care for this population. Docetaxel chemotherapy, given at the time of long-term hormone therapy initiation, showed evidence of improved survival accompanied by an increase in adverse events. Docetaxel treatment should become part of standard of care for adequately fit men commencing long-term hormone therapy.FUNDING: Cancer Research UK, Medical Research Council, Novartis, Sanofi-Aventis, Pfizer, Janssen, Astellas, NIHR Clinical Research Network, Swiss Group for Clinical Cancer Research.

Published
2016
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29. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

Author

James, Nicholas D., primary, de Bono, Johann S., additional, Spears, Melissa R., additional, Clarke, Noel W., additional, Mason, Malcolm D., additional, Dearnaley, David P., additional, Ritchie, Alastair W.S., additional, Amos, Claire L., additional, Gilson, Clare, additional, Jones, Rob J., additional, Matheson, David, additional, Millman, Robin, additional, Attard, Gerhardt, additional, Chowdhury, Simon, additional, Cross, William R., additional, Gillessen, Silke, additional, Parker, Christopher C., additional, Russell, J. Martin, additional, Berthold, Dominik R., additional, Brawley, Chris, additional, Adab, Fawzi, additional, Aung, San, additional, Birtle, Alison J., additional, Bowen, Jo, additional, Brock, Susannah, additional, Chakraborti, Prabir, additional, Ferguson, Catherine, additional, Gale, Joanna, additional, Gray, Emma, additional, Hingorani, Mohan, additional, Hoskin, Peter J., additional, Lester, Jason F., additional, Malik, Zafar I., additional, McKinna, Fiona, additional, McPhail, Neil, additional, Money-Kyrle, Julian, additional, O’Sullivan, Joe, additional, Parikh, Omi, additional, Protheroe, Andrew, additional, Robinson, Angus, additional, Srihari, Narayanan N., additional, Thomas, Carys, additional, Wagstaff, John, additional, Wylie, James, additional, Zarkar, Anjali, additional, Parmar, Mahesh K.B., additional, and Sydes, Matthew R., additional

Published
2017
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30. Adding abiraterone for men with high-risk prostate cancer (PCa) starting long-term androgen deprivation therapy (ADT): Survival results from STAMPEDE (NCT00268476).

Author

James, Nicholas D., primary, De Bono, Johann S., additional, Spears, Melissa Ruth, additional, Clarke, Noel, additional, Mason, Malcolm David, additional, Dearnaley, David P., additional, Ritchie, Alastair W S, additional, Russell, J. Martin, additional, Gilson, Clare, additional, Jones, Robert J., additional, Gillessen, Silke, additional, Matheson, David, additional, Aung, San, additional, Birtle, Alison J., additional, Chowdhury, Simon, additional, Gale, Joanna, additional, Malik, Zafar, additional, O'Sullivan, Joe M., additional, Parmar, Mahesh K B, additional, and Sydes, Matthew Robert, additional

Published
2017
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32. Treatment outcomes in men with metastatic castration-resistant prostate cancer (mCRPC) and cardiovascular disorders or diabetes: The Prostate Cancer Registry.

Author

Lumen, Nicolaas, primary, Chowdhury, Simon, additional, Birtle, Alison J., additional, Bjartell, Anders, additional, Costa, Luis, additional, Feyerabend, Susan, additional, Galli, Luca, additional, Kalinka-Warzocha, Ewa, additional, Kramer, Gero, additional, Maroto, Pablo, additional, Matveev, Vsevolod B, additional, Paiss, Thomas, additional, Pisconti, Salvatore, additional, Spaeth, Dominique, additional, Veiga, Francisco Gomez, additional, Antoni, Laurent, additional, Klumper, Edwin, additional, Wapenaar, Robert, additional, Thoret-Bauchet, Florence, additional, and Lee, Emma, additional

Published
2017
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33. Efficacy of cabazitaxel (CABA) rechallenge in heavily-treated patients with metastatic castration-resistant prostate cancer (mCRPC).

Author

Thibault, Constance, primary, Eymard, Jean-Christophe, additional, Hardy-Bessard, Anne-Claire, additional, Birtle, Alison J., additional, Krainer, Michael, additional, Baciarello, Giulia, additional, Flechon, Aude, additional, Le Moulec, Sylvestre, additional, Spaeth, Dominique, additional, Laguerre, Brigitte, additional, Caffo, Orazio, additional, Deville, Jean-Laurent, additional, Beuzeboc, Philippe, additional, Hasbini, Ali, additional, Gross-Goupil, Marine, additional, Helissey, Carole, additional, Bennamoun, Mostefa, additional, and Oudard, Stephane, additional

Published
2017
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34. Real-world outcomes in second-line treatment of metastatic castration-resistant prostate cancer (mCRPC): The Prostate Cancer Registry.

Author

Chowdhury, Simon, primary, Birtle, Alison J., additional, Bjartell, Anders, additional, Costa, Luis, additional, Feyerabend, Susan, additional, Galli, Luca, additional, Kalinka-Warzocha, Ewa, additional, Kramer, Gero, additional, Lumen, Nicolaas, additional, Maroto, Pablo, additional, Matveev, Vsevolod B, additional, Paiss, Thomas, additional, Pisconti, Salvatore, additional, Spaeth, Dominique, additional, Veiga, Francisco Gomez, additional, Antoni, Laurent, additional, Klumper, Edwin, additional, Wapenaar, Robert, additional, van den Berg, Erik, additional, and Lee, Emma, additional

Published
2017
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36. 5-year patient-reported outcomes of bowel and urinary bother in the CHHiP trial (CRUK/06/016).

Author

Dearnaley, David P., primary, Mossop, Helen, additional, Syndikus, Isabel, additional, Khoo, Vincent, additional, Bloomfield, DJ, additional, Parker, Chris C., additional, Logue, John, additional, Scrase, Christopher D, additional, Birtle, Alison J., additional, Staffurth, John, additional, Malik, Zafar, additional, Panades, Miguel, additional, Eswar, Chinnamani, additional, Graham, John, additional, Russell, J. Martin, additional, Gao, Annie, additional, Wilkins, Anna, additional, Cruickshank, Clare, additional, Griffin, Clare, additional, and Hall, Emma, additional

Published
2017
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37. Real-world outcomes in first-line treatment of metastatic castration-resistant prostate cancer (mCRPC): The prostate cancer registry.

Author

Chowdhury, Simon, primary, Birtle, Alison J., additional, Bjartell, Anders, additional, Costa, Luis, additional, Feyerabend, Susan, additional, Galli, Luca, additional, Kalinka-Warzocha, Ewa, additional, Kramer, Gero, additional, Lumen, Nicolaas, additional, Maroto, Pablo, additional, Matveev, Vsevolod B., additional, Paiss, Thomas, additional, Pisconti, Salvatore, additional, Spaeth, Dominique, additional, Antoni, Laurent, additional, Klumper, Edwin, additional, Wapenaar, Robert, additional, Van Den Berg, Erik, additional, and Lee, Emma, additional

Published
2017
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38. Real-world treatment with abiraterone acetate in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC).

Author

Boegemann, Martin, primary, Hatzinger, Martin, additional, Hercher, Dirko, additional, Matus, Geoffrey, additional, Everaert, Els Grieta, additional, Dopchie, Catherine, additional, Sheehan, Denise, additional, Birtle, Alison J., additional, Garcia Alvarez, Laura, additional, Zou, Lu, additional, Kluska, Martin, additional, Antoni, Laurent, additional, Pissart, Geneviève, additional, Lukac, Martin, additional, and Dearden, Lindsay, additional

Published
2017
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39. Sequencing in metastatic castration-resistant prostate cancer (mCRPC): Updated results of the FLAC International Database.

Author

Delanoy, Nicolas, primary, Angelergues, Antoine, additional, Efstathiou, Eleni, additional, Gyftaki, Revekka, additional, Wysocki, Piotr Jan, additional, Lainez, Nuria, additional, Gonzalez, Iria, additional, Castellano, Daniel E., additional, Ozguroglu, Mustafa, additional, Garcia Carbonero, Iciar, additional, Flechon, Aude, additional, Borrega, Pablo, additional, Guillot, Aline, additional, Campos Balea, Begona, additional, Le Moulec, Sylvestre, additional, Esteban, Emilio, additional, Munarriz, Javier, additional, Barker, Claire, additional, Birtle, Alison J., additional, and Oudard, Stephane, additional

Published
2017
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40. ToTem: A phase Ib trial of temisirolimus with gemcitabine and cisplatin.

Author

Pacey, Simon, primary, Jones, Robert J., additional, Young, Alison Claire, additional, Protheroe, Andrew, additional, Birtle, Alison J., additional, Garcia Corbacho, Javier, additional, Hategan, Mirela, additional, Kumar, Sanjeev, additional, Knowles, Margaret, additional, Loadman, Paul, additional, Griffiths, Gareth, additional, Casbard, Angela Claire, additional, Madden, Tracie-Ann, additional, Adams, Richard, additional, and Chester, John David, additional

Published
2016
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41. The Prostate Cancer Registry: Do patients with metastatic castration-resistant prostate cancer (mCRPC) differ according to metastatic status at diagnosis?

Author

Chowdhury, Simon, primary, Birtle, Alison J., additional, Bjartell, Anders, additional, Costa, Luis, additional, Feyerabend, Susan, additional, Galli, Luca, additional, Kalinka-Warzocha, Ewa, additional, Kramer, Gero, additional, Lumen, Nicolaas, additional, Maroto, Pablo, additional, Matveev, Vsevolod B., additional, Paiss, Thomas, additional, Spaeth, Dominique, additional, Antoni, Laurent, additional, Klumper, Edwin, additional, Wapenaar, Robert, additional, and Lee, Emma, additional

Published
2016
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42. FIESTA: A phase Ib and pharmacokinetic trial of AZD4547 in combination with gemcitabine and cisplatin.

Author

Jones, Robert Hugh, primary, Anthoney, David Alan, additional, Jones, Robert J., additional, Crabb, Simon J., additional, Hussain, Syed A., additional, Birtle, Alison J., additional, Spiliopoulou, Pavlina, additional, Robinson, Timothy, additional, Knowles, Margaret, additional, McLellan, Lyndall, additional, Jones, Hazel, additional, Boylan, Zoe, additional, Landers, Donal, additional, Atuah, Kwame, additional, Sherratt, Debbie, additional, Brown, Sarah R, additional, Flanagan, Louise, additional, Loadman, Paul, additional, Twelves, Chris, additional, and Chester, John David, additional

Published
2016
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43. TOUCAN: A randomised phase II trial of carboplatin and gemcitabine +/- vandetanib in first line treatment of advanced urothelial cell cancer in patients who are not suitable to receive cisplatin.

Author

Jones, Robert J., primary, Crabb, Simon J., additional, Chester, John D., additional, Elliott, Tony, additional, Huddart, Robert Anthony, additional, Birtle, Alison J., additional, Evans, Linda, additional, Lester, Jason Francis, additional, Huang, Chao, additional, Casbard, Angela Claire, additional, Madden, Tracie-Ann, additional, and Griffiths, Gareth, additional

Published
2016
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44. Comparison of hypofractionated high-dose intensity-modulated radiotherapy schedules for prostate cancer: Results from the phase III randomized CHHiP trial (CRUK/06/016).

Author

Dearnaley, David P., primary, Syndikus, Isabel, additional, Mossop, Helen, additional, Birtle, Alison J., additional, Bloomfield, DJ, additional, Cruickshank, Clare, additional, Graham, John, additional, Hassan, Shama, additional, Khoo, Vincent, additional, Logue, John P., additional, Mayles, Helen, additional, Money-Kyrle, Julian, additional, Naismith, Olivia Frances, additional, Panades, Miguel, additional, Patterson, Helen, additional, Scrase, Christopher D, additional, Staffurth, John, additional, Tremlett, Jean, additional, Griffin, Clare, additional, and Hall, Emma, additional

Published
2016
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45. ProCAID: A phase I clinical trial to combine the AKT inhibitor AZD5363 with docetaxel and prednisolone (DP) chemotherapy for metastatic castration resistant prostate cancer (mCRPC).

Author

Crabb, Simon J., primary, Birtle, Alison J., additional, Martin, Karen, additional, Downs, Nichola, additional, Bowers, Megan, additional, Ratcliffe, Ian, additional, Ellis, Mary, additional, Griffiths, Gareth, additional, Thompson, Stuart, additional, Khoo, Vincent, additional, and Jones, Robert J., additional

Published
2016
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46. Development and validation of contouring guidelines for post-cystectomy adjuvant radiation of bladder cancer.

Author

Baumann, Brian C., primary, Bosch, Walter, additional, Bahl, Amit, additional, Birtle, Alison J., additional, Breau, Rodney H., additional, Challapalli, Amarnath, additional, Chang, Albert, additional, Choudhury, Ananya, additional, Daneshmand, Siamak, additional, Feldman, Adam S., additional, Guzzo, Thomas J., additional, Hilman, Serena, additional, Jani, Ashesh B., additional, Malkowicz, S. Bruce, additional, Master, Viraj A., additional, Mitra, Anita, additional, Porten, Sima P., additional, Efstathiou, Jason A., additional, Eapen, Libni, additional, and Christodouleas, John Paul, additional

Published
2016
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47. Phase II randomised placebo controlled neoadjuvant chemotherapy study of nintedanib with gemcitabine and cisplatin in locally advanced muscle invasive bladder cancer.

Author

Hussain, Syed A., primary, Jackson, Richard, additional, Shields, Alice, additional, Dickinson, Lynne, additional, Cornford, Philip, additional, Jones, Robert J., additional, Lester, Jason Francis, additional, Chester, John D., additional, Birtle, Alison J., additional, Powles, Thomas, additional, Crabb, Simon J., additional, Mazhar, Danish, additional, Huddart, Robert Anthony, additional, Protheroe, Andrew, additional, Azam, Faisal, additional, Vasudev, Naveen, additional, Butt, Mohammad, additional, and James, Nicholas David, additional

Published
2015
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48. Cost-effectiveness of zoledronic acid and strontium-89 as bone protecting treatments in addition to chemotherapy in patients with metastatic castrate-refractory prostate cancer. (ISRCTN 12808747) TRAPEZE.

Author

James, Nicholas David, primary, Andronis, Lazaros, additional, Goranitis, Ilias, additional, Pirrie, Sarah, additional, Pope, Ann, additional, Barton, Darren, additional, Daunton, Adam, additional, McLaren, Duncan, additional, O'Sullivan, Joe M., additional, Parker, Chris, additional, Staffurth, John, additional, Stanley, Andrew, additional, Wylie, James, additional, Beesley, Sharon, additional, Birtle, Alison J., additional, Brown, Janet Elizabeth, additional, Chakraborti, Prabir R, additional, Russell, John Martin, additional, and Billingham, Lucinda, additional

Published
2015
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49. Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC).

Author

Wade, Julia, Elliott, Daisy, Avery, Kerry N. L., Gaunt, Daisy, Young, Grace J., Barnes, Rebecca, Paramasivan, Sangeetha, Campbell, W. Bruce, Blazeby, Jane M., Birtle, Alison J., Stein, Rob C., Beard, David J., Halliday, Alison W., Donovan, Jenny L., ProtecT study group, CLASS study group, Chemorad study group, POUT study group, OPTIMA prelim study group, and CSAW study group and ACST-2 study group

Subjects
INFORMED consent (Medical law), TRIALS (Law), CLINICAL trials, PSYCHOMETRICS, RANDOMIZED controlled trials, CLINICAL trial laws, PATIENT participation, ATTITUDE (Psychology), COMMUNICATION, HEALTH attitudes, MEDICAL personnel, MEDICAL protocols, READABILITY (Literary style), RESEARCH evaluation, ACCESS to information, RESEARCH bias, PATIENT selection, PSYCHOLOGY of Research personnel, PSYCHOLOGY of human research subjects, HUMAN research subjects -- Legal status, laws, etc., MEDICAL laws
Abstract

Background: Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative evaluation of the Participatory and Informed Consent (PIC) measure for application to recorded recruitment appointments. The PIC allows the evaluation of recruiter information provision and evidence of participant understanding.Methods: Published guidelines for IC were reviewed to identify potential items for inclusion. Seventeen purposively sampled trial recruitment appointments from three diverse trials were reviewed to identify the presence of items relevant to IC. A developmental version of the measure (DevPICv1) was drafted and applied to six further recruitment appointments from three further diverse trials to evaluate feasibility, validity, stability and inter-rater reliability. Findings guided revision of the measure (DevPICv2) which was applied to six further recruitment appointments as above.Results: DevPICv1 assessed recruiter information provision (detail and clarity assessed separately) and participant talk (detail and understanding assessed separately) over 20 parameters (or 23 parameters for three-arm trials). Initial application of the measure to six diverse recruitment appointments demonstrated promising stability and inter-rater reliability but a need to simplify the measure to shorten time for completion. The revised measure (DevPICv2) combined assessment of detail and clarity of recruiter information and detail and evidence of participant understanding into two single scales for application to 22 parameters or 25 parameters for three-arm trials. Application of DevPICv2 to six further diverse recruitment appointments showed considerable improvements in feasibility (e.g. time to complete) with good levels of stability (i.e. test-retest reliability) and inter-rater reliability maintained.Conclusions: The DevPICv2 provides a measure for application to trial recruitment appointments to evaluate quality of recruiter information provision and evidence of patient understanding and participation during IC discussions. Initial evaluation shows promising feasibility, validity, reliability and ability to discriminate across a range of recruiter practice and evidence of participant understanding. More validation work is needed in new clinical trials to evaluate and refine the measure further. [ABSTRACT FROM AUTHOR]

Published
2017
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