The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,588
150mg p.o. daily
Time to clinical progression
Time frame: Throughout study period
Tolerability in terms of adverse events and laboratory parameters
Time frame: Throughout study period
Survival
Time frame: Throughout study period
Time to treatment failure
Time frame: Throughout study period
Prostate-specific antigen
Time frame: Initial study period up to 2005 amended protocol
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Research Site
Wooloongabba, Queensland, Australia
Research Site
East Melbourne, Victoria, Australia
Research Site
Graz, Austria
Research Site
Linz, Austria
Research Site
Mistelbach, Austria
Research Site
Oberwart, Austria
Research Site
Sankt Pölten, Austria
Research Site
Antwerp, Belgium
Research Site
Bruges, Belgium
Research Site
Brussels, Belgium
...and 118 more locations