|
Intervention(s) (route, frequency, total dose of injection or total dose/day) |
Intervention(s) appropriate as applied in a clinical practice setting a (description) |
Comparator(s) (route, frequency, total dose/day) |
Comparator(s) appropriate as applied in a clinical practice setting a (description) |
EORTC 30846 |
Gosereline (Zoladex) (s.c., every 4 weeks, 3.6 mg) and cryptoterone acetate (p.o., 3 times per day for the first 4 weeks of treatment, 50 mg) or orchiectomy (surgery, once, n.a.) |
s.c. injections and p.o. or surgical intervention |
Same treatment starting at clinical or subjective progression |
s.c. injections and p.o. or surgical intervention |
EORTC 30891 |
Subcapsular orchiectomy or buserelin (s.c. every 2 months, 6.3 mg) and cyproterone acetate (p.o. for the first 2 weeks, 50 mg) |
Surgical intervention or s.c. injections |
Same treatment starting at symptomatic disease progression |
Surgical intervention or s.c. injections |
ECPC |
Bicalutamide (p.o., once daily, 150 mg) and watchful waiting (for oncological outcomes); bicalutamide (p.o., once daily, 150 mg) and standard care including radical prostatectomy, radiotherapy, watchful waiting, or cryotherapy/cryosurgery (for adverse events) |
p.o. |
Placebo (p.o., once daily, n.a.) in addition to standard care |
p.o. |
EST 3886 |
Goserelin (Zoladex) (s.c., every 4 weeks, 3.6 mg) or orchiectomy (surgery, once, n.a.) |
s.c. injections or surgical intervention |
Same treatment starting at disease progression |
s.c. injections or surgical intervention |
Granfors 2006 |
Orchiectomy (surgery, once 3 weeks after the staging operation, n.a.) |
Surgical intervention |
Same treatment starting at disease progression (in 4 cases: LHRH analogues) |
Surgical intervention (in 4 cases: s.c. injections) |
MRC |
Total or subcapsular orchiectomy (surgery, once, n.a.) or LHRH analogues (s.c., ‐, ‐); if for any reason either of these options became inappropriate an alternative form of effective hormone therapy was allowed: cryptoterone acetate, oestrogens, flutamide (‐, ‐, ‐) |
Surgical intervention or s.c. injections |
Same treatment starting at disease progression |
Surgical intervention or s.c. injections |
RTOG 85‐31 |
Goserelin (s.c., every 4 weeks, 3.6 mg) |
s.c. injections |
Same treatment starting at disease progression |
s.c. injections |
SAKK 08/88 |
Subcapsular orchiectomy (surgery, once, n.a.) |
Surgical intervention |
Same treatment starting at disease progression |
Surgical intervention |
TROG 03.06/ VCOG PR 0103 |
LHRH analogues (s.c., ‐, ‐), LHRH antagonists (s.c., ‐, ‐) |
s.c. injections (intermittent ADT: 171/261; continuous ADT: 90/261) |
Same treatment starting at disease progression (symptoms, occurrence of metastases, PSA doubling times decreased to 6 months or less) or at least 2 years after randomisation |
s.c. injections (intermittent ADT: 171/261; continuous ADT: 90/261) |
VACURG |
Orchiectomy (surgery, once, n.a.) and placebo (p.o., ‐, ‐) |
Surgical intervention and p.o. |
Placebo (p.o., ‐, ‐) |
p.o. |
‐ denotes not reported; a The term 'clinical practice setting' refers to the specification of the intervention/comparator as used in the course of a standard medical treatment (such as dose, dose escalation, dosing scheme, provision for the contraindications and other important features); C: comparator; I: intervention; N/CPS: no specification of clinical practice setting possible; s.c.: subcutaneous; p.o.: per os; n.a.: not applicable; LHRH: luteinizing hormone‐releasing hormone; PSA: prostate‐specific antigen |