Manifesto of the ncri psycho-social oncology committee
Prostate CSG Annual report 2009/10 NCRI Prostate Cancer Clinical Studies Group (PCCSG) Introduction This is the first report from the PCCSG following the appointment of Professor Malcolm Mason as the new Chairman, and the Group wish to pay tribute to the immense contribution of the outgoing Chairman, Professor Noel Clarke. The CSG held its strategy meeting in May 2010, and, while this is reported separately elsewhere, the focus of the Group has been defined by this meeting and its outcomes, and by the findings of the international review panel from 2009. We are now in a period of transition, from the previous structure, characterised by Working Groups, to a new structure where the Working Groups are evolving into formal Subgroups. Additionally, the need to strengthen the portfolio in castrate-refractory disease has been a major area of effort, while maintaining the impetus in large-scale studies in other categories of disease. The PCCSG also wishes to maintain and further develop its external links; to that end, international participation in the STAMPEDE trial, and discussions ongoing in RADICALS and with other studies in development, have been most welcome. The Group considered participation in two NCIC studies; ELATT and Pro-START; in the first instance, participation was judged not to be possible, and in the second, a feasibility study in the UK revealed that accrual would not be sufficient to enable further participation. In addition to studies of therapeutic intervention, the Group has also considered others, and the addition of the first imaging studies to the portfolio is very welcome. Membership and structure The PCCSG learned with deep sadness of the death of Jim Stansfeld. Jim had been a consumer representative on the CSG for a number of years, as well as serving on the Trial Management Group for STAMPEDE. He made a huge contribution and will be sadly missed. Professor Ian Jamieson has joined the Group as a new consumer representative and has made valuable contributions already. As before, the ethos of a mix of surgical and non-surgical specialists from a wide geographical area has continued. However, the need for representation from other disciplines has also been recognised, and the PCCSG has recently appointed a pathologist (Dr Alex Freeman) to the Group. As this report goes to press, we hear that a well known basic scientist has also applied to join the CSG, and this, too is very welcome. The Group benefitted greatly from the input of Shama Hassan as the Portfolio Co-ordinator, and was grateful to have had this support. If it is possible to re-instate this in the future that would be welcomed. The need for a more formal subgroup structure has already been referred to. Following the strategy meeting, three subgroups have been defined:
• Low-risk and medium-risk localised disease
• Castrate-sensitive, high risk disease
In the first instance, the current Working Group Chairs will be invited to continue as subgroups chairs (Low/Medium risk, Dr Chris Parker; Castrate sensitive/high risk, Mr David Gillatt; Castrate Resistant, Mr Steve Harland), but at their first meetings, the
Prostate CSG Annual report 2009/10
subgroups will be tasked to review their membership and to consider arrangements for their future chairmanship. Other areas such as imaging, and translational research, will continue to be priorities for the PCCSG, but will continue to develop as cross-cutting themes, and the main CSG will keep an overview of these areas. Portfolio and accrual The PCCSG has continued its emphasis on recruitment to very large clinical trials, and several achievements are noteworthy:
• The ProtecTtrial has completed its recruitment, with over 1600 men
randomised between active surveillance, radical prostatectomy, and radical radiotherapy. This is widely seen, internationally, as a major achievement, which could not have been accomplished outside of the UK. There remains intense worldwide interest in this study.
• The STAMPEDE trial recruited 1565 patients to the end of April 2010. The
second, planned, interim analysis has been performed, and the trial is continuing with all arms open. The Swiss group have recently joined this trial, and discussions with other international groups continue. Discussions are also underway with a view to the introduction of a new arm to the study, and, if successful, this is expected to commence in the next 12 months.
• The CHHIP study was close to completing its target accrual of 2163 patients,
and a new target of 3163 has been approved by CTAAC, in order to increase the power of the study, and to incorporate the use of image guided radiotherapy in selected centres.
The RADICALS study continues to recruit well in the arms addressing duration of hormone therapy, but less well in the arms addressing the timing of radiotherapy. It is hoped that international participation will help with further accrual. The PATCH study successfully completed its planned recruitment, and the next phase of the study, which will run as a feasibility, evolving into a formal phase III study if accrual permits, has recently been approved by CTAAC. In castrate resistant prostate cancer (CRPC), the TRAPEZE study continues to recruit, and the closer links with industry have been maintained, both with the continued recruitment to the VENICE (VEGF-trap) study, but also with the approval of a new randomised phase II study of Saracatenib, under the NCRN-AstraZeneca collaboration. Two other phase II studies are currently under consideration for funding as part of the same initiative. The current portfolio is summarised in Appendix 1. 3825 patients were recruited into studies in 2009/10; 2087 into RCTs and 1738 into non RCTs. Figures for 2008/09 were 3516, 1839 and 1677 respectively. The percentage of incidence cases recruited into studies in 2009/10 was 11.0% (6% to RCTs, 5% to non RCTs). Comparable figures for 2008/09 were 10.7%, 5.6%, 5.1% respectively. Trials in development Discussions have taken place about a number of new studies, which will span the remits of the new subgroups: Prostate CSG Annual report 2009/10 Low-risk or medium-risk disease: Two imaging studies are in development, the first in the use of multifunctional MRI for diagnosis and characterisation (UCL), and the second in the assessment of staging (DMAPS, Cambridge). Two further studies of focal therapy with High-frequency ultrasound have been submitted to the main CSG, and will be considered in more detail by the subgroup. A feasibility study of salvage cryotherapy is also being developed and has recently been approved for funding. Castrate-sensitive/high risk disease: A new feasibility study of intensity-modulated radiotherapy (PIVOTALS) has been approved by CTAAC and will come under the remit of both this subgroup and the low/medium risk subgroup as it is developed. Two imaging studies are also being developed by this subgroup. The first in the use of MRI to evaluate response to first-line hormone therapy in metastatic prostate cancer (in collaboration with the EORTC), and second in the use of MRI surveillance for patients with spinal metastatic disease at risk of progression (ICR, London). The subgroup will also consider a possible study of prostate radiotherapy in patients with newly diagnosed M1 disease, pre-operative radiotherapy in high-risk, localised disease, and a study comparing surgery with radiotherapy in high-risk, localised disease (OPTIMAL, Cambridge). CRPC: Phase II studies using a VEGF receptor tyrosine kinase inhibitor, and using a PARP inhibitor in patients with a defined molecular phenotype are under discussion. The use of anticoagulation in patients treated with Stilboestrol will be further developed by the subgroup, and a replacement study for TRAPEZE using chemotherapy plus a radioisotope will also be further developed. This subgroup will also be tasked with the further development of a strategy for molecular stratification of patients, which might be applied as appropriate in other subgroups.
Publications Details of publications during 2009/10 arising from trials in the portfolio can be found in Appendix 2. Meetings Once again, the joint urological trials meeting with the Bladder, Renal and Testis CSGs was very successful, both as a means of communication/information sharing with the other urological cancer CSGs, and as a way of sharing strategic and intellectual issues. The CSG is well represented on other groups, including the CTRad, and the EORTC GU group. The PR07 study was presented at ASCO in June 2010, and will also be presented at the NCRI conference in November and as a plenary in ASTRO in November 2010. Collaborations The close national and international links have already been referred to here and in previous reports, and these continue. The major international collaborative priorities will continue to be to:
• Seek international participation in STAMPEDE, RADICALS, and possibly other
Prostate CSG Annual report 2009/10
• Develop, through the EORTC, a co-ordinated approach to the design of new
trials in high-risk, localised disease. The Chairman has been invited to join a pan-European group that will ensure that our own activities, such as OPTIMAL, do not take place in isolation from other EORTC initiatives, and vice-versa.
In addition, we will continue to link closely with our colleagues in the NCIC, to explore future trials where a collaborative approach might benefit both parties. Other activities The CSG has been represented on the Complementary Medicines CSDG strategy meeting, and the Chairman will participate in the review of the Breast Cancer CSG later this year. 3-year strategy The Group’s 3-year strategy is to:
• Further develop the portfolio of studies in CRPC, and to incorporate the concept
of molecular stratification of patients with prostate cancer.
• Build on the areas of programmatic research (e.g. STAMPEDE), and to further
develop frameworks for possible future programs (e.g. OPTIMAL/PIVOTALS)
• Ensure that imaging and translational research continue to be adequately
represented in the Groups’ portfolio and thinking.
Priorities for next year The overwhelming priority is the establishment and the running of the new subgroups, and to develop their roles for detailed new study discussions and for effective communication with the main CSG. Professor Malcolm Mason, Chair
Prostate CSG Annual report 2009/10 Appendix 1 Prostate Cancer Clinical Studies Group Portfolio Acronym Title
A study of active surveillance for early Dr Christopher
The Birmingham prostatic neoplasms Professor Maurice Open association study - A genetic and
environmental case control study on prostate cancer in Birmingham
Conventional or hypofractionated high Professor David
dose intensity modulated radiotherapy Dearnaley Dr for prostate cancer
Cancer Research UK Phase 1 Trial of N Avril
given once via bolus intravenous injection for imaging of prostate cancer
An evaluation of focal ablation therapy Mr Mark Emberton Open using high-intensity focused ultrasound in the treatment of localized adenocarcinoma of the prostate
predisposition to prostate cancer: targeted screening in BRCA1/2 mutation carriers and controls - IMPACT
quality of life and toxicity in patients
undergoing external beam radiotherapy plus high dose rate brachytherapy boost compared with patients receiving conformal external beam radiotherapy alone
safety of aflibercept versus placebo administered every 3 weeks in patients treated with docetaxel / prednisone for metastatic androgen-independent prostate cancer
Prostate CSG Annual report 2009/10
prednisone versus prednisone in patients with progressive metastatic hormone-refractory prostate cancer after failure of a docetaxel-based chemotherapy regimen
Study of Single-agent CNTO 888 (an Bono anti-CCL2 Monoclonal Antibody) for the Treatment of Subjects with Metastatic Castrate-Resistant Prostate Cancer
A Phase II Randomized, Double-Blind, Dr Johann De Bono Open Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus in Men With Asymptomatic, Metastatic Castrate-Resistant Prostate Cancer
A Randomised Double Blind, Placebo- Open controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early use of Tadalafil 5mg Once a day and Tadalafil 20mg On Demand Treatment for 9 months in Subjects Undergoing Bilateral Nerve Sparing Radical Prostatectomy (BNSRP)
transCutaneous hormones. A randomised-controlled trial of transcutaneous oestrogen patches versus LHRH analogues in prostate cancer.
A phase 1 dose escalation study of the Professor David
radiotherapy (IMRT) to treat the prostate and pelvic nodes in patients with prostate cancer
interventions for men at high risk of prostate cancer
Prostate CSG Annual report 2009/10
novel treatment strategies in advanced prostate cancer (Northern Prostate Cancer Collaborative (ProMPT))
A phase III study of active surveillance Dr Christopher
patients diagnosed with favourable risk prostate cancer (START)
polymorphisms for predicting the effects of radiotherapy
A multicentre randomised trial of single Professor Peter
Ibandronate for localised metastatic bone pain
randomised evaluation randomised controlled trial of brachytherapy versus radical prostatectomy in good risk prostate cancer: a feasibility study
metastatic prostate cancer: evaluation James of drug efficacy
docetaxel plus prednisolone plus zoledronic acid vs. docetaxel plus prednisolone plus strontium-89 vs. docetaxel plus prednisolone plus zoledronic acid plus strontium-89 in hormone refractory prostate cancer metastatic to bone.
Prostate CSG Annual report 2009/10 Appendix 2
2009/10 Publications and abstracts Bokobza SM, Ye L, Kynaston HE, Jiang WG. GDF-9 promotes the growth of prostate cancer cells by protecting them from apoptosis. J Cell Physiol. 2010 May 10. [Epub ahead of print]PMID: 20458753 [PubMed - as supplied by publisher] Macefield RC, Metcalfe C, Lane JA, Donovan JL, Avery KN, Blazeby JM, Down L, Neal DE, Hamdy FC, Vedhara K; ProtecT Study Group. Impact of prostate cancer testing: an evaluation of the emotional consequences of a negative biopsy result. Br J Cancer. 2010 Apr 27;102(9):1335-40. Epub 2010 Apr 6.PMID: 20372151 [PubMed - in process] Brown M, Hart C, Gazi E, Gardner P, Lockyer N Clarke NW The influence of the omega 6 PUFA arachidonic acid and bone marrow adipocytes on metastatic spread from prostate cancer Brit J Canc 2010: 102(2):403-13 Clarke NW, Marberger M. Open to debate: GnRH agonists are the new way forward in hormone therapy Eur Urol 2010:57(3):534-537. Eeles et al Identification of 7 new prostate cancer susceptibility loci through a genome wide association study Nature Genetics 2010: 41(10):1116-21 Al Alama A et al Multiple loci on 8q21 associated with prostate cancer susceptibility Nature Genetics 2010; 41(10):1058-60 Morris M, Ricketts C, Gentle D, Abdulrahman M, Clarke NW, Brown M, Maher ER. Identification of candidate tumour suppressor genes frequently methylated in renal cell carcinoma. Oncogene 2010: In Press Ramani VACR, Maddineni SB, grey BR, Clarke NW Differential complication rates following radical cystectomy in the irradiated and non-irradiated pelvis Eur Urol 2010 P. R. Warde, M. D. Mason, M. R. Sydes, M. K. Gospodarowicz, G. P. Swanson, P. Kirkbride, E. Kostashuk, J. Hetherington, K. Ding, W. Parulekar,Intergroup randomized phase III study of androgen deprivation therapy (ADT) plus radiation therapy (RT) in locally advanced prostate cancer (CaP) (NCIC-CTG, SWOG, MRC-UK, INT: T94-0110; NCT00002633). NCIC CTG PR.3/MRC PRO7/SWOG JPR3 Investigators. Proc. ASCO 2010 Parker C, Catton C, Sydes MR. Early salvage radiotherapy after radical prostatectomy. J Clin Oncol 2010; 28(3):e45. Gulliford SL, Foo K, Morgan RC, Aird EG, Bidmead AM, Critchley H et al. Dose- volume constraints to reduce rectal side effects from prostate radiotherapy: evidence from MRC RT01 Trial ISRCTN 47772397. Int J Radiat Oncol Biol Phys 2010; 76(3):747- 754. Prostate CSG Annual report 2009/10 Gulliford SL, Partidge M, Sydes MR, Andreyev J, Dearnaley DP. A comparison of dose–volume constraints derived using peak and longitudinal definitions of late rectal toxicity. Radiotherapy and Oncology 2010; 94:241-247. VA Morgan, SF Riches, K Thomas, N Van As, C Parker, S Giles, NM De Souza. Diffusion-weighted MRI for monitoring prostate cancer progression in patients managed by active surveillance. BJR (in press) Venkitaraman R, Thomas K, Grace P, Dearnaley DP, Horwich A, Huddart R, Parker CC. Serum micronutrient and antioxidant levels at baseline and the natural history of men with localised prostate cancer on active surveillance. Tumor Biology (in press) N. J. Van As, N. M. de Souza, S. F. Riches, V. A. Morgan, S. A. Sohaib, D. P. Dearnaley, C. C. Parker. A study of diffusion weighted magnetic resonance imaging in men with untreated localized prostate cancer on active surveillance. Eur Urol (epub ahead of print) Yap TA , Vidal L, Adam J, Stephens P, Spicer J, Shaw H, Ang J-E, Temple G, Bell S, Shahidi M, Uttenreuther-Fischer M, Stopfer P, Futreal A, Calvert H, de Bono JS, Plummer R. Phase I trial of the irreversible ErbB1 (EGFR) and ErbB2 (HER2) kinase inhibitor BIBW 2992 in patients with advanced solid tumors. J Clinical Oncology /2010/267278 in press Coumans FAW, Doggen CJM, Attard G, de Bono JS, Terstappen LWMM. All circulating epCAM+CK+CD45- objects predict overall survival in castration resistant prostate cancer. Annals of Oncology; 2010 Feb 10. [Epub ahead of print]. Attard G, de Bono JS, Clark J, Cooper CS.Clin Cancer Res. 2010 Feb 15;16(4):1340. Harrington KJ, Karapanagiotou EM, Roulstone V, Twigger KR, White CL, Vidal L, Newbold KN, Ahmed M, Thway K, Nutting CM, Coffey M, Harris D, Vile RG, Pandha HS, de Bono JS, Melcher AA. Two-Stage Phase I Dose-Escalation Study of Intratumoral Reovirus Type 3 Dearing and Palliative Radiotherapy in Patients with Advanced Cancers. Clinical Cancer Research, in press, 2010. Sandhu, SK, Yap TA, de Bono JS. Poly (ADP-Ribose0 Polymerase Inhibitors in Cancer Treatment. A Clinical Perspective. Eur J Cancer. 2010 Jan;46(1):9-20. Epub Yap TA, de Bono JS. Mol Cancer Ther. 2010 May 4. Prostate CSG Annual report 2009/10 Shan L, Ambroisine L, Clark J, Yáñez-Muñoz RJ, Fisher G, Kudahetti SC, Yang J, Kia S, Mao X, Fletcher A, Flohr P, Edwards S, Attard G, de Bono J, Young BD, Foster CS, Reuter V, Moller H, Oliver TD, Berney DM, Scardino P, Cuzick J, Cooper CS, Lu YJ. Prostate Cancer Prostatic Dis. 2010 Feb 23. Reid AH, Attard G, Ambroisine L, Fisher G, Kovacs G, Brewer D, Clark J, Flohr P, Edwards S, Berney DM, Foster CS, Fletcher A, Gerald WL, Møller H, Reuter VE, Scardino PT, Cuzick J, de Bono JS, Cooper CS. Transatlantic Prostate Group. Br J Cancer. 2010 Feb 16;102(4):678-84. Epub 2010 Jan 26. Arkenau HT, Olmos D, Ang JE, Barriuso J, Karavasilis V, Ashley S, de Bono J, Judson I, Kaye S. Eur J Cancer. 2008 Jul;44(11):1536-40. Epub 2008 Jun 10. Reid HMR, Attard G, Danila D, Oommen, Olmos D, Fong PC, Molife LR, Hunt J, Messiou C, Parker C, Dearnaley D, Swennenhuid JF, Terstappen LWMM, Lee G, Kheoh T, Molina A, Rayan CJ, Small E, Scher HI de Bono JS. Significant and sustained antitumour activity in post-docetaxel, castration-resistant prostate cancer with the CYP17 inhibitor abiraterone acetate. J Clinical Oncology 2010, Mar 20;28(9):1489- 95. Epub 2010 Feb 16. Danila DC, Morris MJ, de Bono JS, Ryan CJ, Denmeade SR, Smith MR, Taplin ME, Bubley GJ, Kheoh T, Haqq C, Molina A, Anand A, Koscuiszka M, Larson SM, Schwartz LH, Fleisher M, Scher HI. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. J Clin Oncol. 2010 Mar 20;28(9):1496-501. Epub 2010 Feb 16 Fong PC, Yap TA, Boss DS, Carden CP, Mergui-Roelvink M, Gourley C, De Greve J, Lubinski J, Shanley S, Messiou C, A'hern R, Tutt A, Ashworth A, Stone J, Carmichael J, Schellens JH, de Bono JS, Kaye SB. Poly(ADP)-Ribose Polymerase Inhibition: Frequent Durable Responses in BRCA Carrier Ovarian Cancer Correlating With Platinum-Free Interval. J Clin Oncol. 2010 Apr 20. [Epub ahead of print]. Yap TA, Sandhu, SK, Workman P, de Bono JS. Envisioning the future of early anticancer drug development. Nature Reviews Cancer 2010 In press. For publication July Edition. de Bono JS and Ashworth A. Translating cancer research into targeted therapeutics. Nature 2010. In press. Prostate CSG Annual report 2009/10 Zhang N, Sanders AJ, Ye L, Kynaston HG, Jiang WG. Vascular endothelial growth inhibitor, expression in human prostate cancer tissue and the impact on adhesion and migration of prostate cancer cells in vitro. Int J Oncol. 2009 Dec;35(6):1473-80.PMID: 19885571 [PubMed - indexed for MEDLINE] Eeles RA, Kote-Jarai Z, Al Olama AA, et al and UK Genetic Prostate Cancer Study Collaborators/British Association of Urological Surgeons' Section of Oncology; UK ProtecT Study Collaborators; PRACTICAL Consortium, Easton DF. Identification of seven new prostate cancer susceptibility loci through a genome-wide association study. Nat Genet. 2009 Oct;41(10):1116-21. Epub 2009 Sep 20.PMID: 19767753 [PubMed - indexed for MEDLINE] Al Olama AA, Kote-Jarai Z, Giles GG, et al and UK Genetic Prostate Cancer Study Collaborators/British Association of Urological Surgeons' Section of Oncology; UK Prostate testing for cancer and Treatment study (ProtecT Study) Collaborators, Horwich A, Huddart RA, Khoo VS, Parker CC, Woodhouse CJ, Thompson A, Christmas T, Ogden C, Cooper C, Donovan JL, Hamdy FC, Neal DE, Eeles RA, Easton DF Multiple loci on 8q24 associated with prostate cancer susceptibility. Nat Genet. 2009 Oct;41(10):1058-60. Epub 2009 Sep 20.PMID: 19767752 [PubMed - indexed for MEDLINE] Metcalfe C, Tilling K, Davis M, Lane JA, Martin RM, Kynaston H, Powell P, Neal DE, Hamdy F, Donovan JL; ProtecT Study Group Current strategies for monitoring men with localised prostate cancer lack a strong evidence base: observational longitudinal study. Br J Cancer. 2009 Aug 4;101(3):390-4. Epub 2009 Jul 14.PMID: 19603015 [PubMed - indexed for MEDLINE] Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Piérart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito- Urinary Tract Cancer Group Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009 Jun 11;360(24):2516-27.PMID: 19516032 [PubMed - indexed for MEDLINE] Clarke NW, CM Hart, Brown MD Mechanisms of Metastasis in Prostate Cancer Asian Journal of Andrology (2009) 11: 57–67 ND James, M Sydes, NW Clarke et al STAMPEDE: systemic therapy for advancing or metastatic prostate cancer – a multi- arm multi-stage randomised controlled trial BJUI 2009 VAC Ramani, S Bromage, NW Clarke Contemporary Standard for Morbidity and Outcome following Radical CystectomyVAC BJUI 2009: 104: 628-632 Oates J, Grey B, Hart C, Brown M, Clarke NW Hoechst 33342 side population identification is a conserved and unified mechanism in urological cancers Stem Cells and Development 2009 Prostate CSG Annual report 2009/10 MR Sydes, MKB Parmar, ND James, NW Clarke, DP Dearnaley, MD Mason, RC Morgan, K Sanders, PJ Royston and For the STAMPEDE Trial Group. Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial Trials 1051635680260574 2009 P Sutcliffe, S Hummel, E Simpson, T Young, A Rees, A Wilkinson, F Hamdy, N Clarke, J Staffurth. Use of classical and novel biomarkers as prognostic risk factors for localised prostate cancer: a systematic review Health Technology Assessment 2009: Vol 13: No5 DOI:10.3310/hta 13050
National re-audit of urology outpatient practice in the UK. British Journal of Medical and Surgical Urology Sinclair et al 2009
McRonald FE, Morris MR, Gentle D, Winchester L, Baban D, Ragoussis J, Clarke NW, Brown MD, Kishida T, Yao M, Latif F, Maher ER. Mol Cancer. 2009 Jun 3;8:31. PMID: 19493342 Baker MJ, Gazi E, Brown MD, Shanks JH, Clarke NW, Gardner PJ Biophotonics. 2009 Feb;2(1-2):104-13. PMID: 19343689 [PubMed - indexed for MEDLINE] Grey BR, Oates JE, Brown MD, Clarke NW. BJU Int. 2009 Apr;103(7):856-8. Zee Y-K, O’Connor J, Parker G, Jackson A, Clamp A, Taylor B, Clarke NW, Jayson G Imaging angiogenesis of genitourinary tumours Nature Reviews in Urology 2010 doi:10.1038/nrurol.2009.262 Kirby RS, Fitzpatrick JM, Clarke NW Abarelix and other gonadotrophin-releasing hormone antagonists in prostate cancer. BJUI 2009: 104: 1580-1584. Clarke NW Clinical Guidelines: should 5 alpha reductase inhibitors be used for prostate disease, Nature Reviews in Urology 2009: 6(7): 358-9 D.P. Dearnaley, M.D. Mason, M.K.B. Parmar, K.Sanders & M.R. Sydes. Adjuvant therapy with oral sodium clodronate in locally advanced and metastatic prostate cancer: long-term overall survival results from the MRC PR04 and PR05 randomised controlled trials. Lancet Oncology10: 872-6, 2009 Sydes M, Parmar M, James N, Dearnaley D, Mason M, Morgan R et al. Issues in applying multi-arm multi-stage (MAMS) methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial. Trials 2009; 10(39). Dearnaley DP, Mason MD, Parmar MK, Sanders K, Sydes MR. Adjuvant therapy with oral sodium clodronate in locally advanced and metastatic prostate cancer: long-term overall survival results from the MRC PR04 and PR05 randomised controlled trials. The Lancet Oncology 2009; 10(9):872-876. James ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Anderson J et al. Systemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi- arm, multistage randomized controlled trial. BJU Int 2009; 103(4):464-469. Prostate CSG Annual report 2009/10 Buettner F, Gulliford SL, Webb S, Sydes MR, Dearnaley DP, Partridge M. Assessing correlations between the spatial distribution of the dose to the rectal wall and late rectal toxicity after prostate radiotherapy: an analysis of data from the MRC RT01 trial (ISRCTN 47772397). Phys Med Biol 2009; 54(21):6535-6548. Kynaston H, Parker CC, Sydes MR. Re: Ofer Yossepowitch, Anders Bjartell, James A. Eastham, et al. Positive Surgical Margins in Radical Prostatectomy: Outlining the Problem and Its Long-Term Consequences. Eur Urol 2009;55:87-99. European Urology 2009; 55:e107. Parker C, Sydes MR. Re: Ute Ganswindt, Arnulf Stenzl, Michael Bamberg And Claus Belka. Adjuvant Radiotherapy for Patients with Locally Advanced Prostate Cancer--A New Standard? Eur Urol 2008;54:528-42. European Urology 2009; 55(2):e47. F Buettner, S Gulliford, M Partridge, M Sydes, D Dearnaley, and S Webb. Correlations between 3D Dose Distribution and late Rectal Toxicity after Prostate Radiotherapy. Radiotherapy & Oncology 90:S7-Abstract 16, 2009. (Abstract) S Gulliford, K Foo, R. C. Morgan, E. G. Aird, A. M. Bidmead, CC Critchley, PM Evans, S Gianolini, W. P. Mayles, A. R. Moore, B Sanchez, M Partridge, M. R. Sydes, S Webb, and D. P. Dearnaley. Independent Validation of Rectal Dose-volume Constraints using MRC RT01 (ISRCTN47772397) Trial Data. Clinical Oncology 21:249- Abstract 23, 2009. (Abstract) S Gulliford, J Andreyev, M Partridge, M Sydes, and DP Dearnaley. Comparison of peak vs time-dependent late rectal toxicity in prostate radiotherapy. Radiother.Oncol 92:S38-Abstract 97, 2009. (Abstract) S Gulliford, M Partridge, P Evans, S Webb, M Sydes, R Morgan, and D Dearnaley. Fitting the Parameters of the LKB Model for specific Grades & Endpoints of late Rectal Toxicity. Radiotherapy & Oncology 90:S22-Abstract 63, 2009. (Abstract) Ng MK, Van As N, Thomas K, Woode-Amissah R, Horwich A, Huddart R, Khoo V, Thompson A, Dearnaley D and Parker C. Prostate-specific antigen (PSA) kinetics in untreated, localized prostate cancer: PSA velocity vs PSA doubling time. BJU Int. (2009) Apr;103(7):872-6 S Jhavar, J Bartlett, G Kovacs, C Corbishley, D Dearnaley, R Eeles, V Khoo, R Huddart, A Horwich, A Thompson, A Norman, D Brewer, C Cooper and C Parker. Biopsy tissue microarray study of Ki-67 expression in untreated, localised prostate cancer managed by active surveillance. Prostate Cancer and Prostatic Diseases (2009) 12(2):143-7 Haluska P, Worden F, Olmos D, Yin D, Schteingart D, Batzel GN, Paccagnella ML, de Bono JS, Gualberto A, Hammer GD Prostate CSG Annual report 2009/10 Pharmacol. 2009 Aug 2. [Epub ahead of print]
Ang J-E, Olmos D, de Bono JS. CYP17 blockade by abiraterone: further evidence for frequent continued hormone-dependence in castration-resistant prostate Br J Cancer 2009 Feb 17. [Epub ahead of print] Sarker D, Reid A, Yap T, de Bono JS. Targeting PI3K/AKT pathway for the treatment of prostate cancer. Clin Cancer Res 2009;15 4799-4805 Attard G, Reid AH, Olmos D, de Bono JS.Cancer Res. 2009 Jun 15;69(12):4937-40. Epub 2009 Jun 9. Review. Baird R, Kitzen J, Clarke P, Planting A, Reade S, Reid A, Welsh L, Zaro LP, de las Heras B, Judson I, Kaye S, Eskens F, Workman P, de Bono JS, Verweij J. Phase I Safety, Pharmacokinetic and Pharmacogenomic Trial of ES-285, a Novel Marine Cytotoxic Agent, Administered to Adult Patients with Advanced Solid Tumors. Mol Cancer Ther. 2009 Jun;8(6):1430-7. Epub 2009 Jun 9. Plummer R, Vidal L, Griffin M, Lesley M, de Bono JS, Coulthard S, Sludden J, Siu, LL, Chen EX, Oza AM, Reid GK, McLeod R, Besterman JM, Lee C, Judson I, Calvert H, Boddy AV. Phase I study of MG98, an oligonucleotise antisense inhibitor of human DNA methyltransferase 1, given as a 7-day infusion in patients with advanced solid tumors. Clin Cancer Res. 2009 May 1;15(9):3177-83. Epub 2009 Apr 21 Langenberg MHG, van Herpen CML, de Bono JS, Schellens JHM, Unger C, Hoekman K, Blum HE, Fiedler W, Drevs J, Le Maulf F, Fielding A, Robertson J, Voest EE. Effectgive strategies for management of hypertension following VEGF signalling inhibition therapy: results from a phase II randomized, factorial double-blind study of cediranib in patients with advanced solid tumors. J Clin Oncol. 2009 Nov 9. [Epub ahead of print] Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, Mortimer P, Swaisland H, Lau A, O’Connor MJ, Ashworth A, Carmichael J, Kaye SB, Schellens JHM, de Bono JS. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers.N Engl J Med. 2009 Jul 9;361(2):123-34. Epub 2009 Jun 24 Postel-Vinay S, Arkenau H-T, Olmos D, Ang J, Barriuso J, Ashley A, Banerji U, de Bono JS, Judson I Kaye SB. Clinical benefit in Phase-I trials of novel molecularly targeted agents: does dose matter? Br J Cancer (2009) 100, 1373-1378 Prostate CSG Annual report 2009/10 Reid A H & de Bono JS. Molecular characterization of ERG, ETV1- and PTEN-gene loci identifies patients at low and high risk of death from prostate cancer. Br J Cancer 2009 in press Mita AC, Denis LJ, Rowinsky EK, de bono JS, Goetz AD, Ochoa L, Forouzesh B, Beeram M, Patnaik A, Molpus K, Semiond D, Besenval M, Tolcher AW. Phase I and pharmacokinetic study of XRP6258 (RPR 116258A; Cabazitaxel), a novel taxane, administered as a 1-hour infusion every 3 weeks in patients with advanced solid tumors. Clin Cancer Res. 2009 Jan 15;15(2):723-30. Attard G, de Bono JS. Rev Urol. 2009 Sep;6(9):473-5. No abstract available. PMID: 19727145 [PubMed - in process] Attard G, Cooper C, de Bono JS. Steroid Hormone Receptors in Prostate Cancer: A Hard Habit to Break? Cancer Cell 2009; Cancer Cell. 2009 Dec 8;16(6):458-62. Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, Batzel, GN, Yin D, Pritchard-JonesK, Judson I, Worden FP, Gualberto A, Scurr M, de Bono JS, Haluska. Safety, pharmacokinetics, and promising preliminary activity of the anti IGF-1R antibody figitumumab (CP-751,871) in patients with sarcomas and Ewing’s Sarcoma. Lancet Oncol. 2009 Dec 23. [Epub ahead of print] Carden CP, Molife LR, de Bono JS. Predictive biomarkers for targeting insulin-like growth factor-I (IGF-I) receptor. Mol Can Ther. 2009 Aug;8(8):2077-8. Epub 2009 Aug 11 Attard G, Reid AHM, A’Hern R, Parker C, Oommen NB, Folkerd Messiou C, Molife LR, Maier G, Thompson E, Olmos D, Sinha R, Lee G, Dowsett M, Kaye SB Dearnaley D, Kheoh T, Molina A, de Bono JS. Selective inhibition of CYP17 with Abiraterone Acetate is highly active in the treatment of Castration-Resistant Prostate Cancer . J Clinical Oncology. 2009; 27:23, 3742-3748 Lal R, Harris, Postel-Vinay S, de Bono JS. Reovirus: Rationale and clinical update. Current Opinion Mol Ther 2009, 11 (5): 532-539 Tan DS, Thomas GV, Garrett MD, Banerji U, de Bono JS, Kaye SB, Workman P. Cancer J. 2009 Sep-Oct;15(5):406-20. Foster CS, Dodson AR, Ambroisine L, Fisher G, Møller H, Clark J, Attard G, de- Bono J, Scardino P, Reuter VE, Cooper CS, Berney DM, Cuzick J. Prostate CSG Annual report 2009/10 Br J Cancer. 2009 Oct 6;101(7):1137-44. Epub 2009 Aug 25.
Reid AH, Protheroe A, Attard G, Hayward N, Vidal L, Spicer J, Shaw HM, Bone EA, Carter J, Hooftman L, Harris A, de Bono JS. A first-in-man phase I and pharmacokinetic study on CHR-2797 (Tosedostat), an inhibitor of M1 aminopeptidases, in patients with advanced solid tumors. Clin Cancer Res. 2009 Aug 1;15(15):4978-85. Epub 2009 Jul 28. Attard G, Rizzo S, Ledaki I, Clark J, Reid AH, Thompson A, Khoo V, de Bono JS, Cooper CS, Hudson DL. ate. 2009 Oct 1;69(14):1507-20. Lin CC, Beeram M, Rowinsky EK, Takimoto CH, Ng CM, Geyer CE Jr, Denis LJ, de Bono JS, Hao D, Tolcher AW, Rha SY, Jolivet J, PatnaikCancer Chemother Pharmacol. 2009 Dec;65(1):167-75. Epub 2009 May 16. Jhavar S, Brewer D, Edwards S, Kote-Jarai Z, Attard G, Clark J, Flohr P, Christmas T, Thompson A, Parker M, Shepherd C, Stenman UH, Marchbank T, Playford RJ, Woodhouse C, Ogden C, Fisher C, Kovacs G, Corbishley C, Jameson C, Norman A, de Bono J, Bjartell A, Eeles R, Cooper CS.BJU Int. 2009 May;103(9):1256-69. Epub 2008 Nov 25. Carden CP, Sarker D, Postel-Vinay S, Yap TA, Attard G, Banerji U, Garrett MD, Thomas GV, Workman P, Kaye SB, de Bono JS. Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development? Drug Discov Today. 2010 Feb;15(3-4):88-97. Epub 2009 Dec 2.
E-mail Address:____________________________________________ Name: _________________________________________ I prefer to be called: _____________ ◊ Male ◊ Female Last First Mi Mr Mrs Ms Dr Birthdate: ___/___/___ Social Security #:______-______-______ ◊ Single ◊ Married ◊ Divorced ◊ Widowed ◊ Separated Home Address: ____________________________________________________________________
LIST COMPILED PURSUANT TO SECTION 1086 OF THE TAXES CONSOLIDATION ACT, 1997, IN RESPECT OF THE PERIOD BEGINNING ON 1 October 2012 AND ENDING ON 31 December 2012, OF EVERY PERSON – in whose case the Revenue Commissioners accepted a settlement of the kind mentioned in Section 1086. The list also includes cases in which a Penalty Determination was made by the Courts in respect of the same period.