NCT00672282CompletedPhase 3
A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 1,218
- Locations
- 1
- Primary Endpoint
- Survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
A
Placebo Comparator
Intervention: Placebo (Drug)
B
Active Comparator
Intervention: Bicalutamide (Drug)
Outcomes
Primary Outcomes
Survival
Time Frame: Throughout study period
Time to clinical progression
Time Frame: Throughout study period
Secondary Outcomes
- Tolerability in terms of adverse events and laboratory parameters(Throughout study period)
- Time to treatment failure(Throughout study period)
- Prostate-specific antigen(Initial study period up to 2005 amended protocol)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate CancerNon-Metastatic Prostate CancerNCT00673205AstraZeneca3,588
Completed
Not Applicable
A Crossover Study of the Acute Effects of Olanzapine in Healthy VolunteersDiabetes MellitusInsulin ResistanceNCT00741026Milton S. Hershey Medical Center15
Completed
Phase 2
Preoperative Estetrol in Breast CancerBreast CancerNCT00464516Pantarhei Bioscience30
Completed
Phase 2
Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the MembranesPremature BirthNCT02469519Pediatrix194
Completed
Phase 1
A Two-part Multiple Dose Study to Assess the Safety and Effects of AZD3293 in Healthy Elderly and Alzheimer's PatientsHealthy Elderly VolunteersMild-to-moderate Alzheimer's Disease PatientsNCT01795339AstraZeneca47