MRC Clinical Trials Unit at UCL
Institute of Clinical Trials & Methodology
90 High Holborn
RADICALS Protocol v6.0 Substantial Amendment is ready for site processing. Please navigate to the Members Area for documentation and email the Amendment Acknowledgement, ISF Assessment Checklist and Local R&D approval to firstname.lastname@example.org
We are delighted to inform you that RADICALS closed to recruitment on 30th December 2016! The trial started recruitment in November 2007 and successfully randomised 2840 patients to the hormone duration randomisation (RADICALS-HD) and 1396 patients to the radiotherapy timing randomisation (RADICALS-RT).
We have some exciting and important updates which you can read about in the latest version of the RADICALS Newsletter. Highlights include: updated and new CRFs, important trial definitions, an upcoming data chase, co-enrolment with Add-Aspirin and sharing good practice. We hope you take a look and please feel free to get in touch if you have any comments or questions.
RADICALS-HD closed on 30th June 2015 with just under 3000 patients!
RADICALS-RT is still open to recruitment so please continue to support us.
Upon review of our recent event rate projections we have now decided that the ideal time to close to both comparisons in RADICALS-HD would be June 2015.
We are pleased to say that the proposal to extend our recruitment has been approved by the Trial Steering Committee (the executive committee for the trial). By doing so, we envisage that we would attain 88% power by June 2020 for the RT-only vs. RT+ short term HT comparison. Similarly, we should be able to attain 92% power by June 2020 for the RT+ short term HT vs. RT+ long term HT comparison.
We also plan to recruit to RADICALS-RT for longer (perhaps into June 2016) to achieve 80% power. We are very optimistic that we can achieve these target accrual numbers with your continued support.
Princess Margaret Hospital in Toronto put in their 100th patient on 30th October 2013! Well done and congratulations for all your hard work! They now join Guy’s Hospital and Mount Vernon Hospital in London as the centres with more than 100 patients. We look forward to seeing this list grow.
We have reached a fantastic milestone in RADICALS-HD where we now have 1000 patients in each of the two RADICALS-HD comparisons (none vs short and short vs long). Our target accrual is at least 1370 patients in the none-vs-short comparison and at least 1130 patients in the short-vs-long comparison. Currently we have 1916 patients in RADICALS-HD overall and we are hoping to recruit an overall total in excess of 2500 patients, so, we still need everyone to keep up the great work and keep recruiting patients.
May I also take this opportunity to remind you that it is preferable to randomise patients between all three arms in RADICALS-HD as this is the most efficient for the trial.
Having reached this milestone we are optimistic that we can achieve the same in RADICALS-RT and push our accrual figure from 661 to 1000 in good time with your continued support.
Claire Murphy who has been the RADICALS Trial Manager at the MRC CTU since the trial started will no longer be working on the trial. We wish her all the best and will greatly miss her. Dipa Noor will be replacing Claire and can be contacted at email@example.com
Congratulations to Mount Vernon Hospital in the UK for recruiting their 100th patient into the trial! Thank you for all your hard work and keep up the good work!
Over 2000 patients have now been recruited to RADICALS! This is great news to start the year and is down to the hard work of all our participating centres and the support of participants and their families.
We would like to give a special mention to Guy's & St Thomas's Hospital in London who have now recruited their 100th patient! They are the first centre to reach this milestone and their efforts and enthusiasm are much appreciated.
We look forward to working with you all in 2013.
We are pleased to report that we have now recruited over 500 patients to the Radiotherapy Timing Randomisation (RADICALS-RT). This is an important milestone for RADICALS and the trial team would like to thank the research teams, all participants and their families for supporting this randomisation and ask that you continue to support it. We can answer this important question with your help.
Review of Radiotherapy Timing
A newly published paper in European Urology by Stephenson et al (1) looks at combined data from the three trials of post-op radiotherapy timing: SWOG 8794, EORTC 22911 and ARO 96-02. Long-term results from each of these trials have been presented separately in the past, but here they are discussed together in a manuscript written by representatives from each of these trials. No formal combined analyses are presented.
The paper concludes that the results of RADICALS-RT are "eagerly anticipated to inform physicians regarding the merits of adjuvant versus salvage RT for men with an elevated risk of cancer occurrence after RP". The associated editorial by Kibel (2) also emphasises the need for data from high quality contemporary RCT.
RADICALS is recruiting throughout the UK, Canada, Denmark and Ireland. With your continued support and efforts, we will answer these clinically important questions.
References: 1. Stephenson AJ, Bolla M, Briganti A, Cozzarini C, Moul JW, Roach III M, et al. Postoperative Radiation Therapy for Pathologically Advanced Prostate Cancer After Radical Prostatectomy. European Urology 2012;61(3):443-51 2. Kibel AS. Treat Now or Later: The Dilemma of Postoperative Radiotherapy. European Urology 2012;61(3):452-4
The latest RADICALS news can be viewed here:
Record breaking recruitment in RADICALS! Read more in the March edition of the RADICALS newsletter:
Updated CRFs have been sent to all centres and can also be found on the Centres page here. Please ensure you are using the correct version of each CRF.
The latest editions of the RADICALS newsletters are available to read here:
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.
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.
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.
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.
The latest editions of the RADICALS newsletters are available to read here:
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.
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 firstname.lastname@example.org.
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 email@example.com
Issues around the RADICALS trial
The design of RADICALS
Site accreditation for RADICALS