Non-Metastatic Prostate Cancer
Conditions
Keywords
androgen antagonists, prostate neoplasms
Brief summary
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.
Interventions
DRUGBicalutamide
150mg p.o. daily
DRUGPlacebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of non-metastatic cancer of the prostate gland * Patient to be 18 years and above
Exclusion criteria
* Previous systemic therapy for prostate cancer * Previous history of another form of cancer (not prostate) within 5 years of study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to clinical progression | Throughout study period |
| Tolerability in terms of adverse events and laboratory parameters | Throughout study period |
Secondary
| Measure | Time frame |
|---|---|
| Survival | Throughout study period |
| Time to treatment failure | Throughout study period |
| Prostate-specific antigen | Initial study period up to 2005 amended protocol |
Countries
Australia, Austria, Belgium, Czechia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Portugal, South Africa, Spain, United Kingdom
Outcome results
None listed