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Objective: To assess feasibility of a RCT of PA versus RT
for intermediate risk PCa.
Design: A prospective, multi-centre, feasibility study was
conducted to inform the design and conduct of a future
RCT, involving a QuinteT Recruitment Intervention (QRI)
to understand barriers to participation.
Participants: Men with unilateral, intermediate-risk, clinically localised PCa offered randomisation to PA (in the
form of HIFU) or RP.
Results: 82 men were randomised (41 to RP, 41 to PA).
The QRI study was key in identifying recruitment barriers,
and enabled development of tailored strategies to optimise recruitment, which increased from 1.4 patients/
month to 4.5 patients/month. The most common reason
for declining randomisation was treatment preference. 51
(22%) of eligible patients declining randomisation chose
RP, 27 (11%) active surveillance, 26 (11%) PA, and 21 (9%)
radiotherapy. EuroQol EQ-5D-5L utility scores were limited by small numbers but highlight potential health gains
for patients receiving PA compared to RP. HRQoL outcomes relating to urinary and sexual function were better
in the PA than RP group, but no significant differences
were observed in overall HRQoL between groups.
Conclusions: Randomisation of men to a RCT comparing PA and radical treatment for intermediate risk PCa is
feasible. A full RCT of PA versus RT is now warranted.
P6-13 Toxicity of radiotherapy following
radical prostatectomy: a national populationbased study evaluating the impact of timing
and modality
Sujenthiran A1, Parry M1, Nossiter J1, Cathcart P3,
Payne H4, van der Meulen J2, Clarke N5, Aggarwal A3
1Clinical Effectiveness Unit, Royal College of Surgeons, London,
United Kingdom, 2London School of Hygiene & Tropical Medicine,
United Kingdom, 3Guy's & St Thomas' Hospital, London, United
Kingdom, 4University College London Hospital, United Kingdom,
5Salford Royal NHS Foundation Trust, Manchester, United Kingdom
Introduction: Evidence exists supporting the role of
radiotherapy (RT) after radical prostatectomy (RP) in
high-risk prostate cancer. However, concerns remain
about treatment-related toxicity and costs. Aim: To evaluate the impact of timing and modality of post-prostatectomy RT on severe genitourinary (GU) and gastrointestinal
(GI) toxicity.
Methods: We performed a population-based study of
all men treated with post-prostatectomy RT in England
(2010-2013). A validated coding system captured severe
toxicity following RT. A competing-risks regression analysis was used to estimate adjusted hazard ratios (HR)
comparing toxicity between the following groups: (i) RT
< 6 months after RP vs RT > 6 months after RP. (ii)
3D-conformal radiotherapy (3D-CRT) vs Intensitymodulated radiotherapy (IMRT).
Journal of Clinical Urology 11(1S)
Results: Men who started RT > 6 months after RP were
less likely to experience GU toxicity than those who
started RT within 6 months (HR: 0.72, 95% CI: 0.59-0.89;
p<0.01). There was no difference in GI toxicity between
IMRT and 3D-CRT groups (3D-CRT: 5.8 events/100 person years; IMRT: 5.5 events/100 person years; HR: 0.85,
95% CI: 0.63-1.13; p=0.26). GU toxicity was lower but not
statistically significant following IMRT (3D-CRT: 5.4
events/100 person-years; IMRT: 3.8 events/100 personyears; HR: 0.76, 95% CI: 0.55-1.03; p=0.08).
Conclusion: Starting RT at least 6 months post-RP
reduced GU toxicity.The use of post-prostatectomy IMRT
compared to 3D-CRT is not associated with a statistically
significant reduction in rates of severe GU and GI toxicity.
We would recommend waiting at least 6 months after
surgery before starting RT and caution transitioning to
IMRT in the post-prostatectomy setting.
P6-14 PATCH - Prostate adenocarcinoma:
transcutaneous hormones. A randomised
comparison evaluating cardiovascular
morbidity and mortality of transdermal
oestradiol versus luteinising hormone-releasing
hormone agonists in advanced prostate cancer
Langley R1, Duong T1, Clarke N2, Kynaston H3,
Rosen S4, Alhasso A5, Nankivell M1, Dearnaley D6,
Kockelbergh R7, Godsland I10, Sundaram S9, Dixit S10,
Laniado M11, Pope A12, Tyson C1, Goldstein C1, Parmar
M1, Gilbert D1, Abel P
1MRC Clinical Trials Unit At UCL, London, United Kingdom,
2Christie Hospitals NHS Foundation Trust, Department of Urology,
United Kingdom, 3Cardiff School of Medicine, Cardiff University,
United Kingdom, 4National Heart and Lung Institute, Imperial
College London, United Kingdom, 5The Beatson West of Scotland
Cancer Centre, Glasgow, United Kingdom, 6The Institute of Cancer
Research, London, United Kingdom, 7University Hospitals of
Leicester, United Kingdom, 8Division of Diabetes Endocrinology and
Metabolism, London, United Kingdom, 9Mid-Yorkshire Hospitals
NHS Trust, Pinderfields General Hospital, Wakefield, United
Kingdom, 10Scunthorpe General Hospital, North Lincolnshire and
Goole NHS Trust, Scunthorpe, United Kingdom, 11Frimley Health
NHS Foundation Trust, Wexham Park Hospital, United Kingdom,
12The Hillingdon Hospitals NHS Foundation Trust, London, United
Kingdom, 13Imperial College London, London, United Kingdom
Introduction: Androgen deprivation therapy with luteinising hormone-releasing hormone agonists (LHRHa) suppresses testosterone but also depletes oestradiol, leading
to long-term toxicities including osteoporosis.Transdermal
oestradiol (tE2) should avoid the cardiovascular (CVS)
toxicity associated with oral oestrogen, while mitigating
oestradiol depletion-related toxicities.
Patients and Method: PATCH is an ongoing randomised
trial comparing efficacy and safety of tE2 against LHRHa (allocation ratio 2:1< 21/2/2011, then 1:1). Men with advanced
hormone-naïve prostate cancer but no significant CVS disease
Table of Contents for the Digital Edition of JCU - Abstracts of the BAUS 2018 Scientific Meeting - June 2018
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