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RADICALS: Radiotherapy and androgen deprivation in combination after local surgery. A randomised controlled trial in prostate cancer
Which treatments work best after prostate cancer surgery?
  • What is this study about?

    Around 10,000 men with prostate cancer have surgery to remove their prostate in the UK and Canada every year. There is currently no agreement on the best way of treating these men after surgery. Doctors take many different approaches. This trial aims to decide whether it’s best to give men radiotherapy straight after surgery, or wait until there are signs that the cancer may be growing again. The trial also aims to decide whether a man having radiotherapy should also have hormone therapy and if so, for how long
  • Who is included?

    Men who have prostate cancer and surgery to remove their prostate
  • When is it taking place?

    This trial is taking place from late 2007 until mid 2015
  • Where is it taking place?

    Hospitals throughout the UK, Canada, Denmark and Ireland
  • Who is funding the study?

    The trial is being paid for by the Medical Research Council and the charity Cancer Research UK
  • Contact details

  • Further Information

    Type of study:Randomised trial
    Status:Open to recruitment
    Study start date:22-Nov-2007
    Study end date:Mid 2015
    Randomisation target:~3000
    Randomisations achieved:2812, as of 30/11/13
    Also included in this study:Health Economics
    Quality of life outcomes
    Consumer involvement
    NHS Information Centre flagging
    Chief investigator:Dr Chris Parker
    Registration numbers:ISRCTN40814031, EUDRACT 2006-000205-34
    Inclusion criteria:Main entry criteria:
    • • Patient has undergone radical prostatectomy
    • • Prostatic adenocarcinoma
    • • Written informed consent

    Radiotherapy Timing Randomisation:
    • • Post-operative serum PSA less than 0.2 ng/ml
    • • More than 4 weeks and less that 22 weeks after radical prostatectomy
    • • One or more of:
      1. • pT3/4
        • Gleason 7-10 (biopsy or surgical sample)
        • Pre-operative PSA=10ng/ml
        • Positive margine

    Hormone Duration Randomisation:
    • • Patient due to receive post-operative radiotherapy (adjuvant or salvage)
    Exclusion criteria:Main exclusion criteria:
    • • Bilateral orchidectomy
    • • Prior pelvic RT
    • • Other active malignancy likely to interfere with protocol treatment or follow-up
    • • Known distant metastases from prostate cancer
    • • Pre-operative hormone therapy within previos 6 months
    • • Previous pre-operative hormone therapy for longer than 8 months
    • • Any post-operative hormone therapy

    Radiotherapy Timing Randomisation:
    • • Post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA > 0.1 ng/ml OR three consecutive rises in PSA
    • • More than 22 weeks since radical prostatectomy

    Hormone Duration Randomisation:
    • • PSA > 5ng/ml at the time of randomisation
    Intervention and control groups:Other
    Method of randomisation:Minimisation with random element