Main entry
criteria:
[1] Newly
diagnosed high risk N0 M0 patients with:
· At least 2 of: Stage T3/4, PSA ≥
40ng/ml or Gleason sum score
8-10
And intention to treat with
radical radiotherapy
[2] Newly diagnosed M+ or N+
· Stage Tany N+ M0 or Tany
Nany M+ with histological
confirmation
or [3] Previously treated with radical surgery or
radiotherapy, now relapsing
· PSA ≥4ng/ml with doubling time
less than 6 months
· PSA ≥ 20ng/ml
· New metastatic or nodal disease
For all patients
· Histologically confirmed prostate
adenocarcinoma
· Intention to treat with long-term
hormone therapy
· Fit for all protocol treatment and
follow-up, WHO performance status 0-2
· Have completed the appropriate
investigations prior to randomisation
· Adequate haematological
function: neutrophil count >1.5x109/l and
platelets >100x109/l
· Estimated creatinine clearance
>30ml/min
· Serum potassium ≥3.5mmol/L
· Written informed consent
· Willing and expected to comply with
follow-up schedule
· Using effective contraceptive method
if applicable