Eligibility Criteria

All patients must fulfil the main entry criteria and the criteria relevant to the randomisation(s) they are taking part in.

Main Entry Criteria

Inclusion

  • Patient has undergone radical prostatectomy
  • Prostatic adenocarcinoma
  • Written informed consent

Exclusion

  • Bilateral orchidectomy
  • Prior pelvic RT
  • Other active malignancy likely to interfere with protocol treatment or follow-up
  • Known distant metastases from prostate cancer
  • Hormone therapy within previous 6 months
  • Previous pre-operative hormone therapy for longer than 8 months
  • Any post-operative hormone therapy*

Radiotherapy Timing Comaprison

Inclusion

  • Post-operative serum PSA ≤0.2ng/ml
  • More than 4 weeks and less than 22 weeks after radical prostatectomy
  • One or more of:
    • pT3/4
    • Gleason 7-10 (biopsy or surgical sample)
    • Pre-operative PSA ≥10ng/ml
    • Positive margins

Exclusion

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

Hormone Duration Comparison

Inclusion

  • Patient due to receive post-operative radiotherapy (early or deferred)

Exclusion

  • PSA >5ng/ml at the time of randomisation

*Patients joining only the 6 months vs 2 years comparison in RADICALS-HD may begin post-operative hormone therapy prior to randomisation. However, this MUST be discussed with the trials office before the randomisation in this circumstance.

If a patient is eligible to join RADICALS, their doctor should be able to provide information, answer questions about the trial and provide a patient information sheet.


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