Main entry
criteria:
Patients must fulfil one of
the criteria in section 1 or one of the criteria
in section 2. Additionally, all patients must
fulfil the criteria in section 3.
Section 1: High Risk Newly Diagnosed
Patients
…with one of:-
(i) Fulfil at least two out of the three
following criteria, Stage T3/4 N0 M0 histologically confirmed
prostate adenocarcinoma, PSA ≥40ng/ml or Gleason sum score 8-10
(ii) Stage Tany N+ M0 or
Tany Nany M+ histologically confirmed
prostate adenocarcinoma
(iii) Multiple sclerotic bone metastases with
a PSA ≥100ng/ml without histological confirmation
OR
Section 2: Patients with
histologically confirmed prostate adenocarcinoma previously treated
with radical surgery or radiotherapy who are now
relapsing
…with at least one of:-
(i) PSA ≥4ng/ml and rising with doubling time
less than 6 months
(ii) PSA ≥20ng/ml
(iii) N+ and/or M+
Note: Prior hormone therapy
for localised disease must have been completed at least 12 months
previously and have been no longer than 12 months in duration. It
can have been given as adjuvant or neoadjuvant therapy.
AND
Section 3: For all
patients:-
(i) Intention to treat with long-term hormone
therapy
(ii) Fit for all protocol treatment and
follow-up, WHO performance status 0-2
(iii) Have completed the appropriate
investigations prior to randomisation
(iv) Adequate haematological function:
neutrophil count ≥1.5x109/l and platelets
≥100x109/l
(v) Adequate renal function: Serum creatinine
≤1.5 ULN
(vi) Adequate liver function: ALT or AST ≤1.5
ULN, bilirubin ≤ ULN
(vii) Written informed consent
(viii) Willing and expected to comply with
follow-up schedule