scholarly journals Feasibility study of a randomised controlled trial to compare (deferred) androgen deprivation therapy and cryotherapy in men with localised radiation-recurrent prostate cancer

2014 ◽  
Vol 111 (3) ◽  
pp. 424-429 ◽  
Author(s):  
M Salji ◽  
◽  
R Jones ◽  
J Paul ◽  
F Birrell ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomised Controlled Trial ◽  
Androgen Deprivation Therapy ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Androgen Deprivation ◽  
Recurrent Prostate Cancer ◽  
Randomised Controlled

scholarly journals Does exercise impact gut microbiota composition in men receiving androgen deprivation therapy for prostate cancer? A single-blinded, two-armed, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024872 ◽  
Author(s):  
Robert U Newton ◽  
Claus T Christophersen ◽  
Ciaran M Fairman ◽  
Nicolas H Hart ◽  
Dennis R Taaffe ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomised Controlled Trial ◽  
Gut Microbiota ◽  
Microbial Diversity ◽  
Androgen Deprivation Therapy ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Androgen Deprivation ◽  
Gut Health ◽  
Randomised Controlled

IntroductionA potential link exists between prostate cancer (PCa) disease and treatment and increased inflammatory levels from gut dysbiosis. This study aims to examine if exercise favourably alters gut microbiota in men receiving androgen deprivation therapy (ADT) for PCa. Specifically, this study will explore whether: (1) exercise improves the composition of gut microbiota and increases the abundance of bacteria associated with health promotion and (2) whether gut health correlates with favourable inflammatory status, bowel function, continence and nausea among patients participating in the exercise intervention.Methods and analysisA single-blinded, two-armed, randomised controlled trial will explore the influence of a 3-month exercise programme (3 days/week) for men with high-risk localised PCa receiving ADT. Sixty patients will be randomly assigned to either exercise intervention or usual care. The primary endpoint (gut health and function assessed via feacal samples) and secondary endpoints (self-reported quality of life via standardised questionnaires, blood biomarkers, body composition and physical fitness) will be measured at baseline and following the intervention. A variety of statistical methods will be used to understand the covariance between microbial diversity and metabolomics profile across time and intervention. An intention-to-treat approach will be utilised for the analyses with multiple imputations followed by a secondary sensitivity analysis to ensure data robustness using a complete cases approach.Ethics and disseminationEthics approval was obtained from the Human Research Ethics Committee of Edith Cowan University (ID: 19827 NEWTON). Findings will be reported in peer-reviewed publications and scientific conferences in addition to working with national support groups to translate findings for the broader community. If exercise is shown to result in favourable changes in gut microbial diversity, composition and metabolic profile, and reduce gastrointestinal complications in PCa patients receiving ADT, this study will form the basis of a future phase III trial.Trial registration numberANZCTR12618000280202.

Re: Liam Bourke, Stephen Gilbert, Richard Hooper, et al. Lifestyle Changes for Improving Disease-specific Quality of Life in Sedentary Men on Long-term Androgen-Deprivation Therapy for Advanced Prostate Cancer: A Randomised Controlled Trial. Eur Urol 2014;65:865–72;Re: Daniel A. Galvão, Nigel Spry, James Denham, et al. A Multicentre Year-long Randomised Controlled Trial of Exercise Training Targeting Physical Functioning in Men with Prostate Cancer Previously Treated with Androgen Suppression and Radiation from TROG 03.04 RADAR. Eur Urol 2014;65:856–64;Re: Nancy L. Keating, Pang-Hsiang Liu, A. James O’Malley, Stephen J. Freedland, Matthew R. Smith. Androgen-deprivation Therapy and Diabetes Control Among Diabetic Men with Prostate Cancer. Eur Urol 2014;65:816–24;Re: Christina G. Jespersen, Mette Nørgaard, Michael Borre. Androgen-deprivation Therapy in Treatment of Prostate Cancer and Risk of Myocardial Infarction and Stroke: A Nationwide Danish Population-based Cohort Study. Eur Urol 2014;65:704–9

2014 ◽  
Vol 66 (3) ◽  
pp. e51-e52 ◽  
Author(s):  
Sanchia S. Goonewardene ◽  
Raj Persad ◽  
Annie Young ◽  
Adel Makar
Keyword(s):  
Prostate Cancer ◽  
Randomised Controlled Trial ◽  
Androgen Deprivation Therapy ◽  
Controlled Trial ◽  
Population Based ◽  
Androgen Deprivation ◽  
Lifestyle Changes ◽  
Previously Treated ◽  
Randomised Controlled
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