2nd December 2011
Updated CRFs have been sent to all centres and can also be found
on the Information for participating
centres page here. Please ensure you are using the correct
version of each CRF.
24th November 2011
The latest editions of the RADICALS newsletters are available to
read here:
RADICALS-RT
Newsletter
RADICALS-HD
Newsletter
23rd November 2011
The Quality of Life assessment is one of the most important
assessments in RADICALS-RT as there is currently limited
patient-reported data on symptoms and morbidities associated with
treatments after radical prostatectomy. All RADICALS-RT patients
are encouraged to contribute to this part of RADICALS.
It is important that centre staff remember to ask these patients
to complete the forms at baseline, year one, year five and year
ten. Centres will be receiving information soon regarding their
quality of life compliance rates.
16th September 2011
A huge milestone has been reached in the RADICALS trial.
1000 patients have now joined the
RADICALS-HD comparison. Western General Hospital in Edinburgh
randomised the 1000th patient into the comparison. Thanks to them
and all RADICALS centres for the hard work and support for the
trial which means that we are now halfway to completing recruitment
to RADICALS-HD. We are also now over one quarter of the way through
completing recruitment to RADICALS-RT. We hope you can all continue
the hard work which will be needed to complete recruitment to this
large and important trial. You can see more information about
RADICALS accrual here.
News Extra
RADICALS was featured in the Spring/Summer edition of the BUG
(British Uro-Oncology Group) newsletter, BUG Bytes. You can view
that newsletter here
and see more about BUG on their website here.
18th August 2011
A substantial amendment was submitted and
approved by the Royal Free Hospital Research Ethics Committee and
the MHRA for RADICALS. The protocol has now been amended to version
4.0, June 2011. Please note that version 3.0, October 2009 should
now no longer be used. The current version of the protocol can be
found here.
The changes made to the protocol are as a
result of new emerging data from randomised controlled trials that
suggest that the event rate will be lower than originally
anticipated. For the same reason, we will also refocus the primary
outcome measure in RADICALS-RT (the Radiotherapy Timing
Randomisation) from disease-specific survival to
freedom-from-distant metastases (FFDM). FFDM is an earlier outcome
measure with clear clinical relevance and the development of
distant metastases is on the causal pathway to death from prostate
cancer. The trial’s questions about the timing of post-operative
therapy and the use of hormone therapy with radiotherapy remain the
most important questions in this setting.
Several other minor changes have been made to
the protocol, patient information sheets and consent forms. Please
contact the trial team if you would like a detailed list of
changes.
1st March 2011
February was another record month for recruitment into RADICALS.
The highest number of patients per month so far were recruited into
both randomisations. There are now 120 centres accredited to
recruit to RADICALS including our most recently opened centre,
Rigshospitalet in Copenhagen, Denmark. We really appreciate all the
hard work everyone is putting in to increase recruitment rates.
There is more information about accrual per centre on the accrual page.
8th February 2011
The latest editions of the RADICALS newsletters are available to
read here:
RADICALS-RT
Newsletter
RADICALS-HD
Newsletter
1st October 2010
Last month saw the highest number of patients recruited to
RADICALS per month so far with 42 patients randomised. There are
now 105 centres that have been accredited to recruit to RADICALS
and we appreciate all the hard work everyone is putting in to
increase recruitment rates. We hope that October will bring an even
higher rate of recruitment. There is more information about
accrual per centre on the accrual
page.
1st February 2010
There has been an important change to the RADICALS trial which
makes recruitment to the trial much simpler for patients and
clinicians.
RADICALS is an international, multi-centre, randomised
controlled trial for men with prostate cancer. It has two
randomisations for overlapping patient groups: the
Radiotherapy (RT) Timing Randomisation and the Hormone
Duration Randomisation. Accrual to these comparisons has
now been completely separated.
Patients who have had a radical prostatectomy in the past five
months can take part in the RT Timing Randomisation, looking at
early versus deferred post-operative RT. Eligibility for the RT
Timing Randomisation is any risk factor for
recurrence. In other words, most men who have a
radical prostatectomy are eligible for the RT Timing
Randomisation!
Only if and when men are actually going to get post-operative RT
do they need to be approached about the Hormone Duration
Randomisation, which is looking at post-operative RT with or
without hormones.
The trial opened late in 2007 and is now activated in 75 centres
around the UK and a further 9 centres throughout Canada.
If you have any questions or would like more information about
RADICALS, please contact radicals@ctu.mrc.ac.uk.
23rd June 2009
We have prepared a series of very short films about the RADICALS
trial which are available online. RADICALS is a trial of
post-operative radiotherapy and hormone therapy for men with
prostate cancer which is open all across the UK.
These presentations are aimed at researchers who want to know more
about the RADICALS trials or who want to their colleagues to get
involved with the trial. First, there is an interview with Chris
Parker, Chief Investigator of RADICALS, who describes the
background to the trial and some of the practicalities in running
the trial. Second, there is a narrated presentation detailing the
design of the trial from Matthew Sydes, Trial Statistician.
Finally, Claire Murphy, Trial Manager, describes the process of
accreditation for interested sites. Clicking on the questions below
will take you to YouTube where the presentations are hosted. You
will need a sound card.
We hope that you find these videos helpful and informative. Any
feedback on these presentations would be welcome at radicals@ctu.mrc.ac.uk
Issues around the RADICALS trial
1. What is the current
standard of care for men with prostate cancer after radical
prostatectomy?
2. What is the role of
radiotherapy after prostatectomy at the moment?
3.
What are the risks and
benefits of radiotherapy after surgery for prostate
cancer?
4. In which patients
should I be uncertain about the use of post-operative
radiotherapy?
5. What is the role of
hormone therapy with post-operative radiotherapy?
6.
Which groups of men
could join the RADICALS trial?
7. What is the main
outcome measure in the RADICALS trial?
8. When is the best time
to approach men about RADICALS?
9. What is the best way
to recruit men to the trial?
10. What issues should be
considered when recruiting to the trial?
11. What is the role of
urologists and oncologists in RADICALS?
12. Can RADICALS be
discussed at multi-disciplinary team (MDT) meetings?
13. The RADICALS trial
appears complex. Is it really?
14. How many men are
needed to join the RADICALS trial and where is it taking
place?
The design of RADICALS
RADICALS design
slides
Site accreditation for RADICALS
RADICALS accreditation
processes