Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

AstraZeneca1,218 enrolled

Overview

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

1,218

Conditions

Non-Metastatic Prostate Cancer

Interventions

BicalutamideDRUG

150mg p.o. daily

PlaceboDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (54)

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

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

Data from ClinicalTrials.gov

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Research Site

Aalborg, Denmark

Research Site

Charlottenlund, Denmark

Research Site

Copenhagen, Denmark

Research Site

Esbjerg, Denmark

Research Site

Frederiksberg, Denmark

Research Site

Frederikssund, Denmark

Research Site

Glostrup Municipality, Denmark

Research Site

Herlev, Denmark

Research Site

Holbuk, Denmark

Research Site

NYK BING Falster, Denmark

...and 44 more locations