Docetaxel with prednisone or prednisolone for the treatment of ...

Study details and Participant details Intervention details Results Conclusion and
design comments
No difference when included all randomised (N = 227):
I, 49/115 (43%); C, 42/112 (37.5%); p = 0.52
Comments about participants:
Subgroup-baseline PPI score:
Mild pain (PPI 1, 2):
OR = 0.9 (95% CI: 0.5 to 1.7)
Moderate pain (PPI 3, 4):
I, 58% (95% CI: 41 to 77%)
C, 26% (95% CI: 13 to 48%)
OR = 4.6 (95% CI: 1.3 to 15.5, p = 0.04)
Duration of palliative response (time from first date at which
palliative response criteria fulfilled to first date at which
disease progression was noted):
saline over 3 hours
No. of cycles:
Mitoxantrone discontinued
after cumulative dose of
140 mg/m 2 . In patients
with a palliative response,
other study drugs given
until disease progression.
Placebo was withheld if
serum calcium
200 nmol/l.
Length per cycle:
3 weeks
I: median = 6.2 months (95% CI: 5.0 to 9.2)
C: median = 6.4 months (95% CI: 4.0 to 9.6)
No significant difference (p = 0.79)
Outcome 4: PSA Decline
(50% or more decrease in serum PSA compared with
baseline for at least 2 visits) (N = 209):
Inclusion/exclusion criteria:
Histologically confirmed
adenocarcinoma of the prostate or
metastatic carcinoma (presumptive
prostate origin), defined by the
presence of sclerotic bony
metastases and a serum PSA >upper
limit of normal. Radiologically
confirmed, progressive bone disease
(defined as presence of new lesions
on bone scan, increased isotope
uptake at previous sites of disease, or
increasing bone pain). Castrate levels
of testosterone (