Manifesto of the ncri psycho-social oncology committee

Prostate CSG Annual report 2009/10
NCRI Prostate Cancer Clinical Studies Group (PCCSG)

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
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 ProtecT trial 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).
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.

Details of publications during 2009/10 arising from trials in the portfolio can be found in
Appendix 2.
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
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.
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
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,
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-
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
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
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
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 P J 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
Imaging angiogenesis of genitourinary tumours Nature Reviews in Urology 2010
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 Oncology 10: 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)
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)
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,
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Effectgive strategies for management of hypertension following VEGF
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Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA
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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,
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Safety, pharmacokinetics, and promising preliminary activity of
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Lal R, Harris, Postel-Vinay S, de Bono JS. Reovirus: Rationale and clinical update.
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2009 Oct 1;69(14):1507-20.
Lin CC, Beeram M, Rowinsky EK, Takimoto CH, Ng CM, Geyer CE Jr, Denis LJ, de
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Can molecular biomarker-based
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