| 2019 |
Denham JW, Joseph D, Lamb DS, Spry NA, Duchesne G, Matthews J, et al., 'Short-term androgen suppression and radiotherapy versus intermediate-term androgen suppression and radiotherapy, with or without zoledronic acid, in men with locally advanced prostate cancer (TROG 03.04 RADAR): 10-year results from a randomised, phase 3, factorial trial', The Lancet Oncology, 20 267-281 (2019) [C1]
© 2019 Elsevier Ltd Background: The optimal duration of androgen suppression for men with locally advanced prostate cancer receiving radiotherapy with curative intent is yet to be... [more] © 2019 Elsevier Ltd Background: The optimal duration of androgen suppression for men with locally advanced prostate cancer receiving radiotherapy with curative intent is yet to be defined. Zoledronic acid is effective in preventing androgen suppression-induced bone loss, but its role in preventing castration-sensitive bone metastases in locally advanced prostate cancer is unclear. The RADAR trial assessed whether the addition of 12 months of adjuvant androgen suppression, 18 months of zoledronic acid, or both, can improve outcomes in men with locally advanced prostate cancer who receive 6 months of androgen suppression and prostatic radiotherapy. This report presents 10-year outcomes from this trial. Methods: For this randomised, phase 3, 2 × 2 factorial trial, eligible men were 18 years or older with locally advanced prostate cancer (either T2b-4, N0 M0 tumours or T2a, N0 M0 tumours provided Gleason score was =7 and baseline prostate-specific antigen [PSA] concentration was =10 µg/L). We randomly allocated participants in a 2 × 2 factorial design by computer-generated randomisation (using the minimisation technique, and stratified by centre, baseline PSA concentration, clinical tumour stage, Gleason score, and use of a brachytherapy boost) in a 1:1:1:1 ratio to four treatment groups. Patients in the control group received 6 months of neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) and radiotherapy alone (short-term androgen suppression [STAS]); this treatment was either followed by another 12 months of adjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly; intermediate-term androgen suppression [ITAS]), or accompanied by 18 months of zoledronic acid (4 mg every 3 months, intravenously) starting at randomisation (STAS plus zoledronic acid), or both (ITAS plus zoledronic acid). All patients received radiotherapy to the prostate and seminal vesicles, starting from the end of the fifth month of androgen suppression; dosing options were 66, 70, and 74 Gy in 2-Gy fractions per day, or 46 Gy in 2-Gy fractions followed by a high-dose-rate brachytherapy boost dose of 19·5 Gy in 6·5-Gy fractions. Treatment allocation was open label. The primary endpoint was prostate cancer-specific mortality and was analysed according to intention-to-treat using competing-risks methods. The trial is closed to follow-up and this is the final report of the main endpoints. This trial is registered with ClinicalTrials.gov, number NCT00193856. Findings: Between Oct 20, 2003, and Aug 15, 2007, 1071 men were enrolled and randomly assigned to STAS (n=268), ITAS (n=268), STAS plus zoledronic acid (n=268), and ITAS plus zoledronic acid (n=267). Median follow-up was 10·4 years (IQR 7·9¿11·7). At this 10-year follow-up, no interactions were observed between androgen suppression and zoledronic acid so the treatment groups were collapsed to compare treatments according to duration of androgen suppression: 6 months of androgen suppression plus radiotherapy (6AS+RT) versus 18 months of androgen suppression plus radiotherapy (18AS+RT) and to compare treatments according to whether or not patients received zoledronic acid. The total number of deaths was 375 (200 men receiving 6AS+RT and 175 men receiving 18AS+RT), of which 143 (38%) were attributable to prostate cancer (81 men receiving 6AS+RT and 62 men receiving 18AS+RT). When analysed by duration of androgen suppression, the adjusted cumulative incidence of prostate cancer-specific mortality was 13·3% (95% CI 10·3¿16·0) for 6AS+RT versus 9·7% (7·3¿12·0) for 18AS+RT, representing an absolute difference of 3·7% (95% CI 0·3¿7·1; sub-hazard ratio [sHR] 0·70 [95% CI 0·50¿0·98], adjusted p=0·035). The addition of zoledronic acid did not affect prostate cancer-specific mortality; the adjusted cumulative incidence of prostate cancer-specific mortality was 11·2% (95% CI 8·7¿13·7) with zoledronic acid vs 11·7% (9·2¿14·1) without, representing an a...
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| 2018 |
Marcello M, Ebert M, Haworth A, Steigler A, Kennedy A, Joseph D, Denham J, 'Association between treatment planning and delivery factors and disease progression in prostate cancer radiotherapy: Results from the TROG 03.04 RADAR trial', Radiotherapy and Oncology, 126 249-256 (2018) [C1]
© 2017 Background and purpose: To evaluate the impact of treatment planning and delivery factors on treatment outcome as measured by post-treatment disease progression. Materials ... [more] © 2017 Background and purpose: To evaluate the impact of treatment planning and delivery factors on treatment outcome as measured by post-treatment disease progression. Materials and methods: Accruing 813 external beam radiotherapy participants during 2003¿2007, the RADAR trial collected a comprehensive range of clinical treatment factor data for each participant. Both the Fine and Gray competing risks modelling and the Kaplan¿Meier (KM) analysis were undertaken to determine the impact of these factors on local-composite progression (LCP), with 709 participants available for analysis. Results: Participants with treatments involving 7 or more beams experienced significantly higher incidence of LCP, with a sub-hazard ratio (relative to 3-beam participants) of 3.056 (CI: 1.446¿6.458, p < 0.0034). Participants treated with a more rigorous dose calculation algorithm also displayed significantly higher incidence of LCP, with a sub-hazard ratio of 1.686 (CI: 1.334¿2.132, p < 0.0001). The KM analysis resulted in the same groups showing a higher incidence of LCP, with log-rank test results of p = 0.0005 and p = 0.0008 respectively. Conclusions: The RADAR dataset has enabled a successful secondary analysis in which the impact of technical modifications has been assessed, challenging several established hypotheses. Increasingly precise treatments should be complemented with increasing accuracy to avoid potential geometric miss.
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| 2018 |
Marcello M, Ebert MA, Haworth A, Steigler A, Kennedy A, Bulsara M, et al., 'Association between measures of treatment quality and disease progression in prostate cancer radiotherapy: An exploratory analysis from the TROG 03.04 RADAR trial', Journal of Medical Imaging and Radiation Oncology, 62 248-255 (2018) [C1]
© 2017 The Royal Australian and New Zealand College of Radiologists Introduction: Quality assurance methods are incorporated into multicentre radiotherapy clinical trials for ensu... [more] © 2017 The Royal Australian and New Zealand College of Radiologists Introduction: Quality assurance methods are incorporated into multicentre radiotherapy clinical trials for ensuring consistent application of trial protocol and quantifying treatment uncertainties. The study's purpose was to determine whether post-treatment disease progression is associated with measures of the quality of radiotherapy treatment. Methods: The TROG 03.04 RADAR trial tested the impact of androgen deprivation on prostate cancer patients receiving dose-escalated external beam radiation therapy. The trial incorporated a plan-review process and Level III dosimetric intercomparison at each centre, from which variables suggestive of treatment quality were collected. Kaplan¿Meier statistics and Fine and Gray competing risk modelling were employed to test for associations between quality-related variables and the participant outcome local composite progression. Results: Increased ¿dose-difference¿ at the prostatic apex and at the anterior rectal wall, between planned and measured dose, was associated with reduced progression. Participants whose treatment plans included clinical target volume (CTV) to planning target volume (PTV) margins exceeding protocol requirements also experienced reduced progression. Other quality-related variables, including total accrual from participating centres, measures of target coverage and other variations from protocol, were not significantly associated with progression. Conclusions: This analysis has revealed the association of several treatment quality factors with disease progression. Increased dose and dose margin coverage in the prostate region can reduce disease progression. Extensive and rigorous monitoring has helped to maximise treatment quality, reducing the incidence of quality-indicator outliers, and thus reduce the chance of observing significant associations with progression rates.
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| 2017 |
Sharpley CF, Bitsika V, Christie DRH, Bradford R, Steigler A, Denham JW, 'Psychological resilience aspects that mediate the depressive effects of urinary incontinence in prostate cancer survivors 10 years after treatment with radiation and hormone ablation', Journal of Psychosocial Oncology, 35 438-450 (2017) [C1]
© 2017 Taylor & Francis Group, LLC. Repeated surveys of prostate cancer (PCa) patients indicate that their prevalence of depression is well above that for their non-PCa peer... [more] © 2017 Taylor & Francis Group, LLC. Repeated surveys of prostate cancer (PCa) patients indicate that their prevalence of depression is well above that for their non-PCa peers. Although standard first-line treatments for depression are only about 35% effective, some recent comments have suggested that a focus upon the possible correlates (factors that aggravate or mediate depression) might help improve treatment efficacy. To investigate this issue, 144 10 year PCa survivors were asked about the frequency of urinary incontinence, a common side effect of some PCa treatments. The 53 patients who suffered urinary incontinence had significantly higher depression scores on the Zung Self-rating Depression Scale than those patients who did not report urinary incontinence. Using mediation analysis, patients' psychological resilience (PR) significantly mediated the depressive effects of urinary incontinence, but those effects were confined to just one of the five components of PR¿a sense of control over the things that happen to oneself. Implications for treatment models of psychosocial oncology support for PCa survivors are discussed.
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| 2017 |
Sharpley CF, Bitsika V, Christie DRH, Bradford R, Steigler A, Denham JW, 'Total depression and subtypes in prostate cancer survivors 10 years after treatment', European Journal of Cancer Care, 26 e12630-e12630 (2017) [C1]
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| 2017 |
Bitsika V, Sharpley CF, Christie DRH, Bradford R, Steigler A, Denham JW, 'Measuring personal and functional changes in prostate cancer survivors: development and validation of the FADE: data from the TROG 03.04 RADAR trial', Psycho-Oncology, 26 553-555 (2017) [C1]
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| 2016 |
Sridharan S, Steigler A, Spry NA, Joseph D, Lamb DS, Matthews JH, et al., 'Oligometastatic bone disease in prostate cancer patients treated on the TROG 03.04 RADAR trial', Radiotherapy and Oncology, 121 98-102 (2016) [C1]
© 2016 Elsevier Ireland Ltd Background It remains unclear whether eradication of oligometastases by stereotactic body radiation therapy or other means will result in cure or prolo... [more] © 2016 Elsevier Ireland Ltd Background It remains unclear whether eradication of oligometastases by stereotactic body radiation therapy or other means will result in cure or prolongation of survival in some cases, or merely provide palliation. We address this issue with prospectively collected progression and treatment data from the TROG 03.04 RADAR randomised controlled trial for men with locally advanced prostate cancer (PC). Methods Three Fine and Gray competing risk survival models with time-dependent covariates were used to determine whether metastatic progression status at first diagnosis of bony metastases, i.e. number of bony sites involved and presence of prior or simultaneous other sites of progression, impacts on prostate cancer-specific mortality (PCSM) when adjusted for baseline prognostic factors and allocated primary treatment. Results Between 2003 and 2014, 176 of the 1071 subjects developed bone metastases, 152 developed other sites of progression and 91 died of PC. All subjects received secondary treatment using androgen suppression but none received extirpative treatments. The three models found evidence: 1 ¿ of a clear prognostic gradient according to number of bony metastatic sites; 2 ¿ that other sites of progression contributed to PCSM to a lesser extent than bone progression; and 3 ¿ that further bony metastatic progression in men with up to 3 bony metastases had a major impact on PCSM. Conclusion Randomised trials are essential to determine the value of extirpative treatment for oligometastatic bony metastases due to PC.
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| 2016 |
Warren LEG, Chen M-H, Denham JW, Steigler AB, Renshaw AA, Loffredo M, et al., 'Gleason score and the risk of cause-specific and all-cause mortality following radiation with or without 6 months of androgen deprivation therapy for men with unfavorable-risk prostate cancer', JOURNAL OF RADIATION ONCOLOGY, 5 301-308 (2016) [C1]
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| 2015 |
Delahunt B, Egevad L, Srigley JR, Steigler A, Murray JD, Atkinson C, et al., 'Validation of International Society of Urological Pathology (ISUP) grading for prostatic adenocarcinoma in thin core biopsies using TROG 03.04 'RADAR' trial clinical data', Pathology, 47 520-525 (2015) [C1]
Copyright © 2015 Royal College of Pathologists of Australasia. All rights reserved. In 2014 a consensus conference convened by the International Society of Urological Pathology (I... [more] Copyright © 2015 Royal College of Pathologists of Australasia. All rights reserved. In 2014 a consensus conference convened by the International Society of Urological Pathology (ISUP) adopted amendments to the criteria for Gleason grading and scoring (GS) for prostatic adenocarcinoma. The meeting defined a modified grading system based on 5 grading categories (grade 1, GS 3+3; grade 2, GS 3+4; grade 3, GS 4+3; grade 4, GS 8; grade 5, GS 9-10). In this study we have evaluated the prognostic significance of ISUP grading in 496 patients enrolled in the TROG 03.04 RADAR Trial. There were 19 grade 1, 118 grade 2, 193 grade 3, 88 grade 4 and 79 grade 5 tumours in the series, with follow-up for a minimum of 6.5 years. On follow-up 76 patients experienced distant progression of disease, 171 prostate specific antigen (PSA) progression and 39 prostate cancer deaths. In contrast to the 2005 modified Gleason system (MGS), the hazards of the distant and PSA progression endpoints, relative to grade 2, were significantly greater for grades 3, 4 and 5 of the 2014 ISUP grading scheme. Comparison of predictive ability utilising Harrell's concordance index, showed 2014 ISUP grading to significantly out-perform 2005 MGS grading for each of the three clinical endpoints.
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| 2015 |
Denham JW, Steigler A, Joseph D, Lamb DS, Spry NA, Duchesne G, et al., 'Radiation dose escalation or longer androgen suppression for locally advanced prostate cancer? Data from the TROG 03.04 RADAR trial', Radiotherapy and Oncology, 115 301-307 (2015) [C1]
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| 2014 |
Denham JW, Nowitz M, Joseph D, Duchesne G, Spry NA, Lamb DS, et al., 'Impact of androgen suppression and zoledronic acid on bone mineral density and fractures in the Trans-Tasman Radiation Oncology Group (TROG) 03.04 Randomised Androgen Deprivation and Radiotherapy (RADAR) randomized controlled trial for locally advanced prostate cancer', BJU International, 114 344-353 (2014) [C1]
Objective To study the influence of adjuvant androgen suppression and bisphosphonates on incident vertebral and non-spinal fracture rates and bone mineral density (BMD) in men wit... [more] Objective To study the influence of adjuvant androgen suppression and bisphosphonates on incident vertebral and non-spinal fracture rates and bone mineral density (BMD) in men with locally advanced prostate cancer. Patients and Methods Between 2003 and 2007, 1071 men with locally advanced prostate cancer were randomly allocated, using a 2 × 2 trial design, to 6 months i.m. leuprorelin (androgen suppression [AS]) before radiotherapy alone ± 12 months additional leuprorelin ± 18 months zoledronic acid (ZdA), commencing at randomization. The main endpoint was incident thoraco-lumbar vertebral fractures, which were assessed radiographically at randomization and at 3 years, then reassessed by centralized review. Subsidiary endpoints included incident non-spinal fractures, which were documented throughout follow-up, and BMD, which was measured in 222 subjects at baseline, 2 years and 4 years. Results Incident vertebral fractures at 3 years were observed in 132 subjects. Their occurrence was not increased by 18 months' AS, nor reduced by ZdA. Incident non-spinal fractures occurred in 72 subjects and were significantly related to AS duration but not to ZdA. Osteopenia and osteoporosis prevalence rates at baseline were 23.4 and 1.4%, respectively, at the hip. Treatment for 6 and 18 months with AS caused significant reductions in hip BMD at 2 and 4 years (P < 0.01) and ZdA prevented these losses at both time points. Conclusion In an AS-naïve population, 18 months of ZdA treatment prevented the sustained BMD losses caused by 18 months of AS treatment; however, the study power was insufficient to show that AS duration or ZdA influenced vertebral fracture rates. © 2013 The Authors. BJU International © 2013 BJU International.
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| 2014 |
Denham JW, Joseph D, Lamb DS, Spry NA, Duchesne G, Matthews J, et al., 'Short-term androgen suppression and radiotherapy versus intermediate-term androgen suppression and radiotherapy, with or without zoledronic acid, in men with locally advanced prostate cancer (TROG 03.04 RADAR): an open-label, randomised, phase 3 factorial trial', LANCET ONCOLOGY, 15 1076-1089 (2014) [C1]
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| 2013 |
Denham JW, Steigler A, Tai K, Joseph D, Matthews J, Atkinson C, et al., 'Paradoxical metastatic progression following 3 months of neo-adjuvant androgen suppression in the TROG 96.01 trial for men with locally advanced prostate cancer', Radiotherapy and Oncology, 107 123-128 (2013) [C1]
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| 2013 |
Denham JW, Steigler A, 'Picking the Optimal Duration of Hormonal Therapy in Men With High-Risk and Locally Advanced Prostate Cancer Treated With Radiotherapy', Seminars in Radiation Oncology, 23 206-214 (2013) [C1]
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| 2012 |
Wilcox C, Kautto AJ, Steigler A, Denham J, 'Androgen deprivation therapy for prostate cancer does not increase cardiovascular mortality in the long term', Oncology: International Journal of Cancer Research and Treatment, 82 56-58 (2012) [C1]
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| 2012 |
D'Amico AV, Chen M-H, De Castro M, De Castro M, Lamb DS, Steigler A, et al., 'Surrogate endpoints for prostate cancer-specific mortality after radiotherapy and androgen suppression therapy in men with localised or locally advanced prostate cancer: An analysis of two randomised trials', Lancet Oncology, 13 189-195 (2012) [C1]
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| 2012 |
Steigler A, Denham J, Lamb DS, Spry NA, Joseph D, Matthews J, et al., 'Risk stratification after biochemical failure following curative treatment of locally advanced prostate cancer: Data from the TROG 96.01 trial', Prostate Cancer, 2012 1-11 (2012) [C1]
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| 2011 |
Ebert MA, Lamb DS, Joseph DJ, Steigler A, Denham J, 'A methodology for the analysis of PSA response signatures', Radiotherapy and Oncology, 98 198-202 (2011) [C1]
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| 2011 |
Denham J, Lamb DS, Joseph D, Matthews J, Atkinson C, Spry NA, et al., 'Another form of subgroup to beware', Radiotherapy and Oncology, 101 525-526 (2011) [C3]
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| 2011 |
Lamb DS, Denham J, Joseph D, Matthews J, Atkinson C, Spry NA, et al., 'A comparison of the prognostic value of early PSA test-based variables following external beam radiotherapy, with or without preceding androgen deprivation: Analysis of data from the TROG 96.01 randomized trial', International Journal of Radiation Oncology Biology Physics, 79 385-391 (2011) [C1]
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| 2011 |
D'Amico AV, Chen MH, Crook J, Armstrong JG, Malone S, Steigler A, et al., 'Duration of short-course androgen suppression therapy and the risk of death as a result of prostate cancer', Journal of Clinical Oncology, 29 4682-4687 (2011) [C1]
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| 2011 |
Denham J, Steigler A, Lamb DS, Joseph D, Turner S, Matthews J, et al., 'Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial', The Lancet Oncology, 12 451-459 (2011) [C1]
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| 2010 |
Kumar M, Denham J, Steigler A, 'Value of combined androgen blockade in the neoadjuvant treatment of localized prostate cancer: The jury must remain out', Journal of Clinical Oncology, 28 E445-E446 (2010) [C3]
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| 2009 |
Denham J, Steigler A, Wilcox C, Lamb DS, Joseph D, Atkinson C, et al., 'Why are pretreatment prostate-specific antigen levels and biochemical recurrence poor predictors of prostate cancer survival?', Cancer, 115 4477-4487 (2009) [C1]
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| 2009 |
Denham J, Lamb DS, Joseph D, Matthews J, Atkinson C, Spry NA, et al., 'PSA response signatures: A powerful new prognostic indicator after radiation for prostate cancer?', Radiotherapy and Oncology, 90 382-388 (2009) [C1]
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| 2009 |
Capp A, Inostroza-Ponta M, Bill D, Moscato PA, Lai C, Christie D, et al., 'Is there more than one proctitis syndrome? A revisitation using data from the TROG 96.01 trial', Radiotherapy and Oncology, 90 400-407 (2009) [C1]
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| 2009 |
Denham J, Kumar M, Gleeson PS, Lamb DS, Joseph D, Atkinson C, et al., 'Recognizing false biochemical failure calls after radiation with or without neo-adjuvant androgen deprivation for prostate cancer', International Journal of Radiation Oncology Biology Physics, 74 404-411 (2009) [C1]
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| 2009 |
Denham J, Steigler A, Kumar M, Lamb DS, Joseph D, Spry NA, et al., 'Measuring time to biochemical failure in the Trog 96.01 trial: When should the clock start ticking?', International Journal of Radiation Oncology Biology Physics, 75 1008-1012 (2009) [C1]
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| 2008 |
Denham J, Steigler A, Wilcox C, Lamb DS, Joseph D, Atkinson C, et al., 'Time to biochemical failure and prostate-specific antigen doubling time as surrogates for prostate cancer-specific mortality: evidence from the TROG 96.01 randomised controlled trial', Lancet Oncology, 9 1058-1068 (2008) [C1]
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| 2007 |
D'Amico AV, Denham J, Crook J, Chen MH, Goldhaber SZ, Lamb DS, et al., 'Influence of androgen suppression therapy for prostate cancer on the frequency and timing of fatal myocardial infarctions', Journal of Clinical Oncology, 25 2420-2425 (2007) [C1]
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| 2007 |
D'Amico AV, Denham J, Bolla M, Collette L, Lamb DS, Tai KH, et al., 'Short- vs long-term androgen suppression plus external beam radiation therapy and survival in men of advanced age with node-negative high-risk adenocarcinoma of the prostate', Cancer, 109 2004-2010 (2007) [C1]
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| 2005 |
Christie D, Denham J, Steigler A, Lamb D, Turner S, Mameghan H, et al., 'Delayed rectal and urinary symptomatology in patients treated for prostate cancer by radiotherapy with or without short term neo-adjuvant androgen deprivation', Radiotherapy and oncology, 77 117-125 (2005) [C1]
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| 2005 |
Danham JW, Steigler A, Lamb DS, Joseph D, Turner S, Matthews J, et al., 'TROG 96.01: first report of the main endpoints', EJC SUPPLEMENTS, 3 230-231 (2005) |
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| 2005 |
Denham J, Steigler A, Lamb D, Joseph D, Mameghan H, Turner S, et al., 'Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer : results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial', The Lancet, 6 841-850 (2005) [C1]
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| 2005 |
Back M, Ahern V, Delaney G, Graham P, Steigler A, Wratten C, 'Absence of adverse early quality of life outcomes of radiation therapy in breast conservation therapy for early breast cancer', Journal of Medical Imaging and Radiation Oncology, 49 39-43 (2005) [C1]
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| 2004 |
Back M, Guerrieri M, Wratten C, Steigler A, 'Impact of radiation therapy on acute toxicity in breast conservation therapy for early breast cancer', CLINICAL ONCOLOGY, 16 12-16 (2004)
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| 2003 |
Denham J, Steigler A, Kilmurray J, Wratten C, Burmeister B, Lam D, et al., 'Relapse patterns after chemo-radiation for carcinoma of the oesophagus', Clinical Oncology, 15 98-108 (2003) [C1]
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| 2000 |
Steigler A, Mameghan H, Lamb D, Joseph D, Matthews J, Franklin I, et al., 'A quality assurance audit: Phase 111 trial of maximal androgen deprivation in prostate cancer (TROG 96.01)', AUSTRALASIAN RADIOLOGY, 44 65-71 (2000) [C1]
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| 1999 |
Hamilton C, Poulsen M, Walker Q, Krawitz H, Hindley A, Spry N, et al., 'Quality assurance audit in an Australasian phase III trial of accelerated radiotherapy for head and neck cancer (TROG 91.01)', Australasian Radiology, 43 227-232 (1999)
The Trans-Tasman Radiation Oncology Group (TROG) initiated a randomized trial, testing accelerated (twice daily) radiotherapy against conventional radiotherapy for stage III and s... [more] The Trans-Tasman Radiation Oncology Group (TROG) initiated a randomized trial, testing accelerated (twice daily) radiotherapy against conventional radiotherapy for stage III and stage IV squamous cell carcinoma of the head and neck in 1991. In 1996, the Trial Management Committee arranged for a technical audit of 76 cases from 11 institutions, conducted by investigators from interstate institutions. A 10% unacceptable protocol violation rate was detected, which compares favourably with initial Radiation Therapy Oncology Group (RTOG) experience in the late 1970s. Infrastructural deficits with poor quality of documentation, incomplete retrieval of films and document return have been demonstrated in some cases. The Trans-Tasman Radiation Oncology Group is actively pursuing procedural and resourcing issues in order to redress this and is actively expanding its Quality Assurance (QA) Programme with an intercentre dosimetry study. Ultimately, comprehensive clinical and technical QA site visits are planned.
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