Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Non-metastatic Prostate Cancer

Treatments: Drug: Placebo; Drug: Bicalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00657904

7054IL/0023

D6876C00023

Details and patient eligibility

About

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.

Enrollment: 3,618 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,618 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Bicalutamide

2

Placebo Comparator group

Treatment:

Drug: Placebo