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.