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

Study details and Participant details Intervention details Results Conclusion and
design comments
Outcome 3: Response rate (N = 234)
Best response (in either measurable disease, assessable
disease or bone-only disease. Complete response defined as
disappearance of all disease by scans, and normalisation of
PSA, ≤ 4 ng/mL, sustained for ≥ 28 days. Partial response for
measurable disease was defined as ≥ 50% reduction in
bi-dimensional measurable disease for ≥ 4 weeks or a partial
response for any of the 3 categories was a ≥ 80% reduction
in PSA for ≥ 6 weeks) (see also PSA decline)
No complete responses were observed
Partial responses:
I, 8 (7%); C, 5 (4%); no significant difference (p = 0.375)
progression or treatment
failure (encouraged until
death)
QoL, no analgesic use:
I, 35%; C, 40%
From Center for Drug
Evaluation and Research: 20
Maximum cumulative dose
of mitoxantrone was
160 mg/m 2
Protocol deviations: 2 in
each treatment arm never
started treatment
Stable disease:
I, 65/116 (56%); C, 5/118 (42%)
Post hoc analysis, number of patients with complete
response, partial response or stable disease:
I, 73/116 (64%); C, 55/118 (47%); p = 0.012
White race:
I, 88%; C, 93%
Comments about participants:
Inclusion/exclusion criteria:
Patients with metastatic prostate
cancer, who had undergone no more
than 1 prior endocrine manipulation
(however, this criterion was removed
after accrual of 60 patients). Patients
were required to have adequate
hepatic, renal and bone marrow
function. Anti-androgen withdrawal
and documented disease progression
were required before trial entry
every 2 months.
QoL assessments at
study entry,
6 weeks, 12 weeks
then 12-week
intervals thereafter,
until final assessment
at treatment failure.
QoL assessments
used were FLIC,
symptom distress
scale, sexual and
urologic functioning
scale, problems in
daily activities scale,
impact of pain on
daily activities
instrument
© Queen’s Printer and Controller of HMSO 2007. All rights reserved.
Outcome 4: PSA decline (N = 228)
Defined as ≥ 50% or ≥ 80% reduction in serum PSA from
baseline at between 4 and 8 weeks of follow-up:
Health Technology Assessment 2007; Vol. 11: No. 2
PSA response (%) I: n (%) C: n (%)