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Sexual Function in Men with Castrate Levels of Testosterone: Observations of a Subgroup of Sexually Active Men with Prostate Cancer Undergoing Androgen Deprivation Therapy  [PDF]
Evan Ng, Tammy Corica, Sandra Turner, Adeline Lim, Nigel Spry
Open Journal of Urology (OJU) , 2014, DOI: 10.4236/oju.2014.47017

Purpose: To identify possible factors that influence sexual function in men undergoing maximal androgen deprivation therapy (ADT). Patients and Methods: A descriptive exploration was performed looking at characteristics of twenty-two men reporting sexual activity after nine months of maximal ADT. This previously published Phase II study, involved 250 prostate cancer patients undergoing intermittent ADT. An analysis between this cohort and the group that did not maintain sexual function was performed to ascertain if age, testosterone level, functional status or maintenance of quadriceps strength had an impact upon sexual function. Results: There was no difference in age, testosterone level or ECOG performance status between the sexually active and non-sexually active groups. Over the course of 9 months of ADT, the sexually active group appeared to maintain quadriceps muscle strength as measured with physical stands, and maintained overall health as measured by quality of life questionaries, compared to the non-sexually active group. Conclusions: This retrospective study suggests that exercise during ADT may reduce the impact of ADT on sexual function. This warrants further testing, and could be the focus of future randomised controlled trials.

Can exercise ameliorate treatment toxicity during the initial phase of testosterone deprivation in prostate cancer patients? Is this more effective than delayed rehabilitation?
Newton Robert U,Taaffe Dennis R,Spry Nigel,Cormie Prue
BMC Cancer , 2012, DOI: 10.1186/1471-2407-12-432
Abstract: Background There has been substantial increase in use of androgen deprivation therapy as adjuvant management of prostate cancer. However, this leads to a range of musculoskeletal toxicities including reduced bone mass and increased skeletal fractures compounded with rapid metabolic alterations, including increased body fat, reduced lean mass, insulin resistance and negative lipoprotein profile, increased incidence of cardiovascular and metabolic morbidity, greater distress and reduced quality of life. Numerous research studies have demonstrated certain exercise prescriptions to be effective at preventing or even reversing these treatment toxicities. However, all interventions to date have been of rehabilitative intent being implemented after a minimum of 3 months since initiation of androgen deprivation, by which time considerable physical and psychological health problems have manifested. The pressing question is whether it is more efficacious to commence exercise therapy at the same time as initiating androgen deprivation, so treatment induced adverse effects can be immediately attenuated or indeed prevented. Methods/design We are proposing a multi-site randomized controlled trial with partial crossover to examine the effects of timing of exercise implementation (immediate or delayed) on preserving long-term skeletal health, reversing short- and long-term metabolic and cardiovascular risk factors, and supporting mental health in men receiving androgen deprivation therapy. 124 men who are about to initiate androgen deprivation for prostate cancer will be randomized to immediate or delayed groups. Immediate will commence a 6-month exercise program within 7–10 days of their first dose. Delayed will receive usual care for 6 months and then commence the exercise program for 6 months (partial cross-over). Immediate will be free to adopt the lifestyle of their choosing following the initial 6-month intervention. Measurements for primary and secondary endpoints will take place at baseline, 6 months and 12 months. Discussion This project is unique as it explores a fundamental question of when exercise implementation will be of most benefit and addresses both physical and psychological consequences of androgen deprivation initiation. The final outcome may be adjunct treatment which will reduce if not prevent the toxicities of androgen deprivation, ultimately resulting in reduced morbidity and mortality for men with prostate cancer. Trial registration ACTRN12612000097842
Risk Stratification after Biochemical Failure following Curative Treatment of Locally Advanced Prostate Cancer: Data from the TROG 96.01 Trial
Allison Steigler,James W. Denham,David S. Lamb,Nigel A. Spry
Prostate Cancer , 2012, DOI: 10.1155/2012/814724
A randomized controlled trial of an exercise intervention targeting cardiovascular and metabolic risk factors for prostate cancer patients from the RADAR trial
Daniel A Galv?o, Nigel Spry, Dennis R Taaffe, James Denham, David Joseph, David S Lamb, Greg Levin, Gillian Duchesne, Robert U Newton
BMC Cancer , 2009, DOI: 10.1186/1471-2407-9-419
Abstract: Multi-site randomized controlled trial of 370 men from the RADAR study cohort undergoing treatment or previously treated for prostate cancer involving androgen deprivation therapy in the cities of Perth and Newcastle (Australia), and Wellington (New Zealand). Participants will be randomized to (1) supervised resistance/aerobic exercise or (2) printed material comprising general physical activity recommendations. Participants will then undergo progressive training for 6 months. Measurements for primary and secondary endpoints will take place at baseline, 6 months (end of intervention), and at 6 months follow-up.This study uses a large existent cohort of patients and will generate valuable information as to the continuing effects of exercise specifically targeting cardiovascular function and disease risk, insulin metabolism, abdominal obesity, physical function, quality of life and psychological distress. We expect dissemination of the knowledge gained from this project to reduce risk factors for the development of co-morbid diseases commonly associated with androgen deprivation therapy such as cardiovascular disease, obesity, metabolic disease and diabetes, as well as improvements in physical and functional ability, and quality of life.ACTRN12609000729224Advancing age increases the vulnerability to cancer and the risk for other comorbid conditions (e.g. cardiovascular disease, diabetes, osteoporosis, arthritis and sarcopenia) [1] that can compromise physical function and independent living, ultimately culminating in death. The high prevalence of cancer and comorbidity-related conditions, apart from exacting a high personal, family and community cost, places a heavy burden on the health care system. Lifestyle interventions that can ameliorate toxicities of treatment, and improve ability to self care are seen as highly desirable.Androgen deprivation therapy (ADT) leads to a number of adverse effects including deterioration of the musculoskeletal system and increased ri
A phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer
Robert U Newton, Dennis R Taaffe, Nigel Spry, Robert A Gardiner, Gregory Levin, Bradley Wall, David Joseph, Suzanne K Chambers, Daniel A Galv?o
BMC Cancer , 2009, DOI: 10.1186/1471-2407-9-210
Abstract: Multi-site randomized controlled trial of 195 men (65 subjects per arm) undergoing treatment for prostate cancer involving ADT in the cities of Perth and Brisbane in Australia. Participants will be randomized to (1) resistance/impact loading exercise, (2) resistance/cardiovascular exercise groups and (3) usual care/delayed exercise. Participants will then undergo progressive training for 12 months. Measurements for primary and secondary endpoints will take place at baseline, 6 and 12 months (end of the intervention).The principal outcome of this project will be the determination of the strength of effect of exercise on the well established musculoskeletal, cardiovascular and insulin metabolism side effects of androgen deprivation in prostate cancer patients. As this project is much longer term than previous investigations in the area of exercise and cancer, we will gain knowledge as to the continuing effects of exercise in this patient population specifically targeting bone density, cardiovascular function, lean and fat mass, physical function and falls risk as primary study endpoints. In terms of advancement of prostate cancer care, we expect dissemination of the knowledge gained from this project to reduce fracture risk, improve physical and functional ability, quality of life and ultimately survival rate in this population.A Phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer; ACTRN12609000200280Worldwide prostate cancer is the second most common cancer in men representing 19% of cancers among men in developed countries [1]. With the aging of the population in developed and developing countries the incidence of all cancers, which are normally higher in those aged > 65 years, is predicted to substantially rise, particularly for colon and prostate cancer which are well established aging-related cancers [2]. Advancing age not only increases the vulnerability to cancer but also the risk for other como
Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial
Daniel A Galv?o, Dennis R Taaffe, Prue Cormie, Nigel Spry, Suzanne K Chambers, Carolyn Peddle-McIntyre, Michael Baker, James Denham, David Joseph, Geoff Groom, Robert U Newton
BMC Cancer , 2011, DOI: 10.1186/1471-2407-11-517
Abstract: Multi-site randomized controlled trial in Western Australia and New South Wales to examine the efficacy and safety of a modular multi-modal physical exercise program in 90 prostate cancer survivors with bone metastases. Participants will be randomized to (1) modular multi-modal exercise intervention group or (2) usual medical care group. The modular multi-modal exercise group will receive a 3-month supervised exercise program based on bone lesion location/extent. Measurements for primary and secondary endpoints will take place at baseline, 3 months (end of the intervention) and 6 months follow-up.Delaying or preventing skeletal complication and improving physical function for men with bone metastases would provide clinically meaningful benefits to patients. However, exercise programs must be designed and executed with careful consideration of the skeletal complications associated with bone metastatic disease and cumulative toxicities from androgen deprivation such as osteoporosis and increased risk of fractures. The results from this study will form the basis for the development of a specific exercise prescription in this patient group in order to alleviate disease burden, counteract the adverse treatment related side-effects and enhance quality of life.ACTRN: ACTRN12611001158954Metastases to bone occurs in approximately 80% of men with advanced prostate cancer [1] and the majority of these patients are at risk of developing pathological fractures, hypercalcemia, bone marrow suppression and nerve compressions or spinal cord compressions that result in significant morbidity, limited function and decreased quality of life [2-4]. The clinical course of metastatic bone disease in prostate cancer survivors is relatively long, with a 5-year survival rate of approximately 30% [5]. Prostate cancer causes predominately sclerotic lesions and commonly metastasize to the pelvis and axial skeleton [6]. Therefore, patients with bone metastases experience considerable morbidity re
Risk Stratification after Biochemical Failure following Curative Treatment of Locally Advanced Prostate Cancer: Data from the TROG 96.01 Trial
Allison Steigler,James W. Denham,David S. Lamb,Nigel A. Spry,David Joseph,John Matthews,Chris Atkinson,Sandra Turner,John North,David Christie,Keen-Hun Tai,Chris Wynne
Prostate Cancer , 2012, DOI: 10.1155/2012/814724
Abstract: Purpose. Survival following biochemical failure is highly variable. Using a randomized trial dataset, we sought to define a risk stratification scheme in men with locally advanced prostate cancer (LAPC). Methods. The TROG 96.01 trial randomized 802 men with LAPC to radiation?±?neoadjuvant androgen suppression therapy (AST) between 1996 and 2000. Ten-year follow-up data was used to develop three-tier post-biochemical failure risk stratification schemes based on cutpoints of time to biochemical failure (TTBF) and PSA doubling time (PSADT). Schemes were evaluated in univariable, competing risk models for prostate cancer-specific mortality. The performance was assessed by c-indices and internally validated by the simple bootstrap method. Performance rankings were compared in sensitivity analyses using multivariable models and variations in PSADT calculation. Results. 485 men developed biochemical failure. c-indices ranged between 0.630 and 0.730. The most discriminatory scheme had a high risk category defined by PSADT?<?4 months or TTBF?<?1 year and low risk category by PSADT?>?9 months or TTBF?>?3 years. Conclusion. TTBF and PSADT can be combined to define risk stratification schemes after biochemical failure in men with LAPC treated with short-term AST and radiotherapy. External validation, particularly in long-term AST and radiotherapy datasets, is necessary. 1. Introduction Biochemical failure is a very common problem in the treatment of prostate cancer. Klotz has estimated that approximately 40% of men treated curatively by prostatectomy or radiotherapy will develop biochemical failure [1]. In the United States, the figure is expected to be at least 60,000 per annum [2]. Outcomes following biochemical failure are known to be highly variable. Clinical signs of local or distant progression can follow within months but may take years to become evident, and five year prostate cancer-specific survival probability has been shown to vary between 35% and 100% [3]. An important breakthrough in the management of prostate cancer is the emergence of effective new options for the treatment of castrate-resistant prostate cancer (CRPC) [4]. Presently these options are routinely withheld until castration-resistant tumour growth develops; however, many clinicians now believe that earlier intervention may be beneficial. The identification of subgroups of men with unfavourable outcomes after biochemical failure, needing immediate treatment and/or new therapeutic agents, is therefore a high priority in clinical prostate cancer research. Prognostic data can provide
RU486 Reversal of Cortisol Repression of 1,25-Dihydroxyvitamin D3 Induction of the Human Osteocalcin Promoter  [PDF]
Nigel A. Morrison
Open Journal of Endocrine and Metabolic Diseases (OJEMD) , 2013, DOI: 10.4236/ojemd.2013.31009

In conditions of corticosteroid excess, such as Cushing’s syndrome, a reduction in serum osteocalcin is observed and bone loss occurs. The human osteocalcin gene is induced by 1,25-dihydroxyvitamin D3 derivatives and repressed by glucocorticoids. In this paper we show that cortisol, a natural glucocorticoid, represses both basal and vitamin D induced activity of the human osteocalcin promoter. Furthermore, we address the specific question as to whether the anti-progestin anti-glucocorticoid RU486 is able to antagonize the inhibitory effect of cortisol on osteocalcin gene expression. We show that RU486 has agonist activity alone, in that it is able to repress the basal promoter activity of the osteocalcin gene and antagonist activity, reversing incompletely the cortisol mediated repression of 1,25-dihydroxyvitamin D3 induction.

Analysis and Comparison of Power Electronic Converters for Conventional and Toroidal Switched Reluctance Machines  [PDF]
Zipan Nie, Nigel Schofield
Energy and Power Engineering (EPE) , 2017, DOI: 10.4236/epe.2017.94017
Abstract: Different power electronic converter topologies are introduced in this paper for both Conventional Switched Reluctance Machine (CSRM) and Toroidal Switched Reluctance Machine (TSRM) drive systems. Their commutation, switch and diode currents, power losses, and efficiencies under over modulation operation are analyzed and compared for converter characteristics study, performance evaluation and topology selection for CSRM and TSRM drive systems. The switch and diode silicon volumes required for each CSRM and TSRM drives are also compared according to their corresponding currents at the equivalent machine torque versus speed operating points.
Implementation of analytical technologies in a pharmaceutical development organization looking into the next millennium
Nigel North
Journal of Analytical Methods in Chemistry , 2000, DOI: 10.1155/s1463924600000055
Abstract: Managing the implementation of new technology in a pharmaceutical development environment has provided challenges and opportunities to obtain benefits from technologies, e.g. laboratory automation. Successful application of new techniques requires a dedicated resource. Within Pharmaceutical Technologies, this was initially a single person, who has since evolved into a team dedicated to the investigation and development of robotics and non-invasive analytical techniques. Pharmaceutical development is an important interface between research and commercial manufacturing. In research, the success of genomics and combinatorial chemistry will result in a significant increase in the number of development compounds, and this, combined with the desire of commercial manufacturing to move towards parametric release, puts an emphasis on the need for rapid analytical methods. Some ideas on the techniques that will be required to meet these goals will be described together with their impact on automation.
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