Browsing by author "James, Nicholas"
Now showing items 1-20 of 71
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Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol.
Attard, G; Murphy, L; Clarke, NW; Cross, W; Jones, RJ; et al. (ELSEVIER SCIENCE INC, 2022-01-29)BACKGROUND: Men with high-risk non-metastatic prostate cancer are treated with androgen-deprivation therapy (ADT) for 3 years, often combined with radiotherapy. We analysed new data from two randomised controlled phase 3 ... -
Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5-year follow-up results from the STAMPEDE randomised trial (NCT00268476).
James, ND; Clarke, NW; Cook, A; Ali, A; Hoyle, AP; et al. (WILEY, 2022-08-01)Abiraterone acetate plus prednisolone (AAP) previously demonstrated improved survival in STAMPEDE, a multiarm, multistage platform trial in men starting long-term hormone therapy for prostate cancer. This long-term analysis ... -
Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy.
James, ND; de Bono, JS; Spears, MR; Clarke, NW; Mason, MD; et al. (MASSACHUSETTS MEDICAL SOC, 2017-07-27)BACKGROUND: Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a ... -
Abiraterone in "High-" and "Low-risk" Metastatic Hormone-sensitive Prostate Cancer.
Hoyle, AP; Ali, A; James, ND; Cook, A; Parker, CC; et al. (ELSEVIER, 2019-12-01)BACKGROUND: Abiraterone acetate received licencing for use in only "high-risk" metastatic hormone-naïve prostate cancer (mHNPC) following the LATITUDE trial findings. However, a "risk"-related effect was not seen in the ... -
Accumulation of copy number alterations and clinical progression across advanced prostate cancer.
Grist, E; Friedrich, S; Brawley, C; Mendes, L; Parry, M; et al. (BMC, 2022-09-05)BACKGROUND: Genomic copy number alterations commonly occur in prostate cancer and are one measure of genomic instability. The clinical implication of copy number change in advanced prostate cancer, which defines a wide ... -
Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer: directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol.
Sydes, MR; Spears, MR; Mason, MD; Clarke, NW; Dearnaley, DP; et al. (OXFORD UNIV PRESS, 2018-05-01)BACKGROUND: Adding abiraterone acetate with prednisolone (AAP) or docetaxel with prednisolone (DocP) to standard-of-care (SOC) each improved survival in systemic therapy for advanced or metastatic prostate cancer: evaluation ... -
Adding Celecoxib With or Without Zoledronic Acid for Hormone-Naïve Prostate Cancer: Long-Term Survival Results From an Adaptive, Multiarm, Multistage, Platform, Randomized Controlled Trial.
Mason, MD; Clarke, NW; James, ND; Dearnaley, DP; Spears, MR; et al. (AMER SOC CLINICAL ONCOLOGY, 2017-05-10)Purpose Systemic Therapy for Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy is a randomized controlled trial using a multiarm, multistage, platform design. It recruits men with high-risk, locally ... -
Addition of docetaxel or bisphosphonates to standard of care in men with localised or metastatic, hormone-sensitive prostate cancer: a systematic review and meta-analyses of aggregate data.
Vale, CL; Burdett, S; Rydzewska, LHM; Albiges, L; Clarke, NW; et al. (ELSEVIER SCIENCE INC, 2016-02-01)BACKGROUND: Results from large randomised controlled trials combining docetaxel or bisphosphonates with standard of care in hormone-sensitive prostate cancer have emerged. In order to investigate the effects of these ... -
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.
Woods, BS; Sideris, E; Sydes, MR; Gannon, MR; Parmar, MKB; et al. (ELSEVIER, 2018-12-01)BACKGROUND: Results from large randomised controlled trials have shown that adding docetaxel to the standard of care (SOC) for men initiating hormone therapy for prostate cancer (PC) prolongs survival for those with ... -
Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial.
Clarke, NW; Ali, A; Ingleby, FC; Hoyle, A; Amos, CL; et al. (OXFORD UNIV PRESS, 2019-12-01)BACKGROUND: STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report ... -
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.
James, ND; Sydes, MR; Clarke, NW; Mason, MD; Dearnaley, DP; et al. (ELSEVIER SCIENCE INC, 2016-03-19)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 ... -
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.
Hussain, SA; Lester, JF; Jackson, R; Gornall, M; Qureshi, M; et al. (ELSEVIER SCIENCE INC, 2022-05-01)BACKGROUND: Recurrence is common after neoadjuvant chemotherapy and radical treatment for muscle-invasive bladder cancer. We investigated the effect of adding nintedanib to neoadjuvant chemotherapy on response and survival ... -
Association of Bone Metastatic Burden With Survival Benefit From Prostate Radiotherapy in Patients With Newly Diagnosed Metastatic Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial.
Ali, A; Hoyle, A; Haran, ÁM; Brawley, CD; Cook, A; et al. (AMER MEDICAL ASSOC, 2021-04-01)IMPORTANCE: Prostate radiotherapy (RT) improves survival in men with low-burden metastatic prostate cancer. However, owing to the dichotomized nature of metastatic burden criteria, it is not clear how this benefit varies ... -
Best Current Practice and Research Priorities in Active Surveillance for Prostate Cancer-A Report of a Movember International Consensus Meeting.
Moore, CM; King, LE; Withington, J; Amin, MB; Andrews, M; et al. (ELSEVIER, 2023-01-27)BACKGROUND: Active surveillance (AS) is recommended for low-risk and some intermediate-risk prostate cancer. Uptake and practice of AS vary significantly across different settings, as does the experience of surveillance-from ... -
Boosting and broadening recruitment to UK cancer trials: towards a blueprint for action
Nanton, V; Bryan, RT; Pope, AM; Hughes, A; Jefferson, K; et al. (BMJ, 2023-11-01)<jats:p>Recruitment and retention in cancer trials are long-standing issues, exacerbated by the COVID-19 pandemic. The UK National Institute of Health Research and leading clinicians have emphasised the urgency to achieve ... -
Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons.
Hague, D; Townsend, S; Masters, L; Rauchenberger, M; Van Looy, N; et al. (BMC, 2019-05-29)BACKGROUND: There is limited research and literature on the data management challenges encountered in multi-arm, multi-stage platform and umbrella protocols. These trial designs allow both (1) seamless addition of new ... -
Chemoradiotherapy in Muscle-invasive Bladder Cancer: 10-yr Follow-up of the Phase 3 Randomised Controlled BC2001 Trial.
Hall, E; Hussain, SA; Porta, N; Lewis, R; Crundwell, M; et al. (ELSEVIER, 2022-05-13)BACKGROUND: BC2001, the largest randomised trial of bladder-sparing treatment for muscle-invasive bladder cancer (MIBC), demonstrated improvement in locoregional control by adding fluorouracil and mitomycin C to radiotherapy ... -
Clinical Guidance for the Management of Patients with Urothelial Cancers During the COVID-19 Pandemic - Rapid Review.
Patel, K; Choudhury, A; Hoskin, P; Varughese, M; James, N; et al. (ELSEVIER SCIENCE LONDON, 2020-06-01)The current COVID-19 pandemic presents a substantial obstacle to cancer patient care. Data from China as well as risk models suppose that cancer patients, particularly those on active, immunosuppressive therapies are at ... -
Clinical Outcomes and Survival Following Treatment of Metastatic Castrate-Refractory Prostate Cancer With Docetaxel Alone or With Strontium-89, Zoledronic Acid, or Both: The TRAPEZE Randomized Clinical Trial.
James, ND; Pirrie, SJ; Pope, AM; Barton, D; Andronis, L; et al. (AMER MEDICAL ASSOC, 2016-04-01)IMPORTANCE: Bony metastatic castrate-refractory prostate cancer (CRPC) has a poor prognosis and high morbidity. Zoledronic acid (ZA) is commonly combined with docetaxel in practice but lacks evidence that combining is ... -
Combined exome and transcriptome sequencing of non-muscle-invasive bladder cancer: associations between genomic changes, expression subtypes, and clinical outcomes.
Goel, A; Ward, DG; Noyvert, B; Yu, M; Gordon, NS; et al. (BMC, 2022-06-03)BACKGROUND: Three-quarters of bladder cancer patients present with early-stage disease (non-muscle-invasive bladder cancer, NMIBC, UICC TNM stages Ta, T1 and Tis); however, most next-generation sequencing studies to date ...