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-operative 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.