Browsing Clinical Studies by author "James, Nicholas"
Now showing items 1-20 of 26
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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 ... -
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 ... -
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 ... -
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 ... -
Correlation of Clinician- and Patient-Reported Outcomes in the BC2001 Trial.
Philipps, L; Porta, N; James, N; Huddart, R; Hafeez, S; et al. (ELSEVIER SCIENCE LONDON, 2023-05-01)AIMS: To evaluate whether there is sufficient correlation between patient-reported outcomes (PROs) and clinician-reported outcomes (CROs) in bladder cancer follow-up post-radiotherapy to streamline data collection and to ... -
Differences in Quality of Life and Toxicity for Male and Female Patients following Chemo(radiotherapy) for Bladder Cancer.
Philipps, L; Porta, N; James, N; Huddart, R; Hafeez, S; et al. (ELSEVIER SCIENCE LONDON, 2023-02-01)AIMS: BC2001, a randomised trial of treatment for muscle-invasive bladder cancer, demonstrated no difference in health-related quality of life (HRQoL) or late toxicity between patients receiving radical radiotherapy with ... -
Failure-Free Survival and Radiotherapy in Patients With Newly Diagnosed Nonmetastatic Prostate Cancer: Data From Patients in the Control Arm of the STAMPEDE Trial.
James, ND; Spears, MR; Clarke, NW; Dearnaley, DP; Mason, MD; et al. (AMER MEDICAL ASSOC, 2016-03-01)IMPORTANCE: The natural history of patients with newly diagnosed high-risk nonmetastatic (M0) prostate cancer receiving hormone therapy (HT) either alone or with standard-of-care radiotherapy (RT) is not well documented. ... -
Getting our ducks in a row: The need for data utility comparisons of healthcare systems data for clinical trials.
Sydes, MR; Murray, ML; Ahmed, S; Apostolidou, S; Bliss, JM; et al. (Elsevier BV, 2024-03-25)BACKGROUND: Better use of healthcare systems data, collected as part of interactions between patients and the healthcare system, could transform planning and conduct of randomised controlled trials. Multiple challenges to ... -
Hypofractionated radiotherapy in locally advanced bladder cancer: an individual patient data meta-analysis of the BC2001 and BCON trials.
Choudhury, A; Porta, N; Hall, E; Song, YP; Owen, R; et al. (ELSEVIER SCIENCE INC, 2021-02-01)BACKGROUND: Two radiotherapy fractionation schedules are used to treat locally advanced bladder cancer: 64 Gy in 32 fractions over 6·5 weeks and a hypofractionated schedule of 55 Gy in 20 fractions over 4 weeks. Long-term ... -
Management of patients with advanced prostate cancer-metastatic and/or castration-resistant prostate cancer: Report of the Advanced Prostate Cancer Consensus Conference (APCCC) 2022.
Gillessen, S; Bossi, A; Davis, ID; de Bono, J; Fizazi, K; et al. (ELSEVIER SCI LTD, 2023-05-01)BACKGROUND: Innovations in imaging and molecular characterisation together with novel treatment options have improved outcomes in advanced prostate cancer. However, we still lack high-level evidence in many areas relevant ... -
Management of Patients with Advanced Prostate Cancer. Part I: Intermediate-/High-risk and Locally Advanced Disease, Biochemical Relapse, and Side Effects of Hormonal Treatment: Report of the Advanced Prostate Cancer Consensus Conference 2022.
Gillessen, S; Bossi, A; Davis, ID; de Bono, J; Fizazi, K; et al. (ELSEVIER, 2023-03-01)BACKGROUND: Innovations in imaging and molecular characterisation and the evolution of new therapies have improved outcomes in advanced prostate cancer. Nonetheless, we continue to lack high-level evidence on a variety of ... -
Management of patients with advanced prostate cancer: recommendations of the St Gallen Advanced Prostate Cancer Consensus Conference (APCCC) 2015.
Gillessen, S; Omlin, A; Attard, G; de Bono, JS; Efstathiou, E; et al. (ELSEVIER, 2015-08-01)The first St Gallen Advanced Prostate Cancer Consensus Conference (APCCC) Expert Panel identified and reviewed the available evidence for the ten most important areas of controversy in advanced prostate cancer (APC) ... -
Management of Patients with Advanced Prostate Cancer: Report from the Advanced Prostate Cancer Consensus Conference 2021.
Gillessen, S; Armstrong, A; Attard, G; Beer, TM; Beltran, H; et al. (ELSEVIER, 2022-07-01)BACKGROUND: Innovations in treatments, imaging, and molecular characterisation in advanced prostate cancer have improved outcomes, but various areas of management still lack high-level evidence to inform clinical practice. ... -
Management of Patients with Advanced Prostate Cancer: Report of the Advanced Prostate Cancer Consensus Conference 2019.
Gillessen, S; Attard, G; Beer, TM; Beltran, H; Bjartell, A; et al. (ELSEVIER, 2020-04-01)BACKGROUND: Innovations in treatments, imaging, and molecular characterisation in advanced prostate cancer have improved outcomes, but there are still many aspects of management that lack high-level evidence to inform ... -
Management of Patients with Advanced Prostate Cancer: The Report of the Advanced Prostate Cancer Consensus Conference APCCC 2017.
Gillessen, S; Attard, G; Beer, TM; Beltran, H; Bossi, A; et al. (ELSEVIER SCIENCE BV, 2018-02-01)BACKGROUND: In advanced prostate cancer (APC), successful drug development as well as advances in imaging and molecular characterisation have resulted in multiple areas where there is lack of evidence or low level of ... -
MRE11 as a Predictive Biomarker of Outcome After Radiation Therapy in Bladder Cancer.
Walker, AK; Karaszi, K; Valentine, H; Strauss, VY; Choudhury, A; et al. (ELSEVIER SCIENCE INC, 2019-07-15)PURPOSE: Organ-confined muscle-invasive bladder cancer is treated with cystectomy or bladder preservation techniques, including radiation therapy. There are currently no biomarkers to inform management decisions and aid ... -
Outcomes in Patients with Muscle-invasive Bladder Cancer Treated with Neoadjuvant Chemotherapy Followed by (Chemo)radiotherapy in the BC2001 Trial.
Hussain, SA; Porta, N; Hall, E; Salawu, A; Lewis, R; et al. (ELSEVIER, 2021-02-01)BACKGROUND: BC2001 demonstrated improved local control with the addition of chemotherapy to radiotherapy in 360 patients with muscle-invasive bladder cancer. OBJECTIVE: To establish whether such benefit remained in BC2001 ...