Table 1 Study details of trials employing PEP at 240 mg monthly

Study population

Advanced (T0–4, Nx, M1, grades 1–3)

Locally advanced (T3–4, M0) or metastatic (T1–4, M1)

Newly detected untreated advanced

Recruitment period

December 1992 to June 1997

January 1990 to March 1994

Not reported

Patients recruited (withdrawn)

917 (7)

444^a (not reported)

33 (0)

Disease status

T0 (n=5) 0.5%

T1 (n=33) 4%

T2 (n=146) 16%

T3 (n=493) 54%

T3 (n=22) 66%

T4 (n=n=208) 23%

T4 (n=11) 33%

(missing (n=25))

All M1 100%

T3–4, M0 (n=244) 55%

M0 (n=29) 88%

T1–4, M1 (n=200) 45%

M1 (n=4) 12%

G1 (n=136) 15%

G1 (n=111) 25%

G2 (n=414) 45%

G2 (n=261) 59%

G2 (n=20) 61%

G3 (n=340) 40%

G3 (n=72) 16%

G3 (n=13) 39%

(missing (n=20))

Follow-up

Median follow-up:

2 years, subgroup analyses at 3 and 10 years

2 years

PEP 27.1 months

Comparator: 27.4 months, brief report for 12 years

Dose

240 mg every 2 weeks for 2 months then 240 mg month⁻¹

320 mg initial dose then 240 mg month⁻¹

240 mg every 2 weeks for 2 months then 240 mg month⁻¹

Comparator

Orchidectomy or combined androgen ablation

Orchidectomy

Orchidectomy

Adjuvant therapy

No

Pretreatment breast irradiation

Pretreatment breast irradiation

Cardiovascular criteria

No myocardial or cerebral infarct 1 month or less before the start of study

No symptomatic coronary heart disease

Patients with previous cardiovascular disease were included

Study quality

High

Randomisation poorly reported

Randomisation poorly reported