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Gilliland et al.
33
The presence of undiagnosed micrometastatic disease
at diagnosis and subsequent BCR leads on to the discussion
about salvage treatments and their effectiveness.
Overall, what is evident is that there is a lack of consistency
in treatments used in these patients. The majority
who received treatment for their BCR underwent local
radiotherapy to the prostate bed alone, in others prostate
bed radiotherapy was combined with variable durations of
ADT (6 weeks, 6 months, 2 years, 3 years). Other
approaches included intermittent and continuous ADT
(7.1%) and even chemotherapy. These significant variations
in the use of adjuvant and salvage treatments in highrisk
patients postoperatively are well documented. Figures
for adjuvant and salvage therapies vary between 1.9-100%
and 0.7% and 87%, respectively.27
Another important consideration is that half of the
patients with BCR were managed with observation only.
This underlines the fact that BCR in many high-risk
patients does not translate into immediately life-threatening
disease and observation should remain an option for
appropriate cases. This is not a new discovery when we
consider recruitment numbers needed in high-risk CaP trials
to demonstrate significant outcomes. For example,
although the CALGB 90203 trial recruited nearly 1000
patients to examine the role of chemotherapy prior to surgery
in high-risk patients and recruited nearly a decade
ago, it is still not powered to show an overall survival benefit.35
What the authors are aware of is the importance the
actual biology of individual cancers.36
Figure 3 illustrates the different salvage treatment
modalities and their effect on subsequent BCR. What is
particularly interesting is the effectiveness of prostate bed
radiotherapy alone in the immediate BCR group (i.e. those
with probable systemic recurrence). The data demonstrate
that none of the patients treated with this approach had a
durable response, with 48.3% (29 patients) going on to
have further salvage treatments, with the remainder managed
with observation of their subsequent BCR. This is
seen visually in Figure 3 and is emphasised by the log-rank
analysis between radiotherapy alone and all other treatments
which all include a systemic component. This is not
a unique observation; a recent retrospective analysis by
Bartkowiak et al.37 concluded that radiotherapy given to
patients with PSA persistence (immediate BCR) and highrisk
features is unlikely to provide a durable response. If
we assume that these patients have undiagnosed micrometastatic
disease, it is not surprising that further localised
treatment to the prostate bed is ineffective at achieving a
PSA response.
The present study does have some limitations. Although
our outcome data are robustly and accurately collected,
they are not randomised. We would hope that this 'realworld'
data could complement randomised data on the
treatment approaches for these patients. We have mentioned
the importance of collecting functional outcomes
data. However, despite the fact that we now routinely collect
pre and postoperative information using the MLUTS
and SHIM questionnaires, the functional assessments used
here are not validated and do not include QoL data. In
addition, the present study is based on postoperative highrisk
characteristics. Although the present cohort represents
what has been termed 'very high-risk CaP'26 findings may
not be completely transferable to patients identified on
preoperative parameters as high risk, as these patients are
a much more heterogeneous group. Furthermore, we have
also included a small number of patients in our analyses
who received preoperative ADT, which will obviously
affect the BCR rates following surgery.
In conclusion, the present study documents the largest
contemporary UK cohort of patients undergoing surgery
with pathological pT3a, pT3b and N1 disease. It documents
extremely favourable surgical, functional and oncological
outcomes. It illustrates the fact that BCR in many
high-risk patients does not translate into immediately lifethreatening
disease and observation should remain an
option in appropriate patients. It also documents the lack
of consistency as to when and which salvage treatments
are used. Finally, it questions the effectiveness of further
local treatments when in fact a more systemic approach
maybe more suitable.
Conflicting interests
The author(s) declare that there is no conflict of interest.
Funding
The authors received no financial support for the research,
authorship, and/or publication of this article.
Ethical approval
The authors have completed the MRC/NHS HRA tool and ethics
approval is not required for this work.
Informed consent
Specific patient consent was not required.
Guarantor
AK.
Contributorship
Niall Gilliland: co-first author and statistical analysis; Anthony
Koupparis: co-first author, supervisor and first draft and review
of manuscript; Sarath Vennam, Julian Peacock, Matthew
Crockett, Jon Oxley, Tim Porter and Elizabeth Wayne: data collection;
Sam Kearley and Robert Geraghty: data and statistical
analysis; Jon Aning and Edward Rowe:- review of manuscript.
Acknowledgements
The authors would like to acknowledge Mark Wright, Raj Persad
and David Gillat who have been part of the pelvic oncology team.

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