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Important changes to the RADICALS trial

08 March 2010

There has been an important change to the RADICALS trial. The two randomisations in the trial have been uncoupled and can now be considered to be completely separate in version 3.0 of the protocol.

Patients who have had a radical prostatectomy in the past 5 months can take part in RADICALS RT, looking at early versus deferred post-op RT. Only if and when they are definitely going to get post-op RT do they need to know about RADICALS HD, looking at RT +/- hormones.

Eligibility for RADICALS RT is for men with any risk factor for recurrence (i.e. Gleason 7-10, or pT3, or margin +ve, or presenting PSA>10 or any combination). In other words, most men who have a radical prostatectomy are eligible for the RT Timing Randomisation.

This is an important change and should make recruitment to the RT question much simpler for patients and clinicians. In addition, we now have a DVD for patients to take away and find out more about the trial.  They can also find the same video on YouTube (just search RADICALStrial). And the RADICALS trial website will be going live soon. You can read more about the trial in the latest RADICALS newsletter.