(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer (Capri)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Non-Metastatic Prostate Cancer

Treatments: Drug: Placebo; Drug: Bicalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00673205

7054IL/0024

D6876C00024

Details and patient eligibility

About

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.

Enrollment: 3,588 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,588 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Placebo

B

Active Comparator group

Treatment:

Drug: Bicalutamide