Non-metastatic Prostate Cancer
Conditions
Keywords
androgen antagonists, prostate neoplasms
Brief summary
The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.
Interventions
DRUGBicalutamide
150mg daily
DRUGPlacebo
once daily
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
* Prostate cancer in the early stage of disease * Prostate removed and/or radiation therapy to the prostate area
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 |
| Overall patient survival | Throughout study period |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure | Throughout study period |
| Serum prostate-specific antigen | Initial study period up to 2006 amended protocol |
| Tolerability in terms of adverse events and laboratory parameters | Throughout study period |
Countries
Canada, United States
Outcome results
None listed