Casodex vs Placebo in Non-Metastatic Early Prostate Cancer (SPCG6)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Non-Metastatic Prostate Cancer

Treatments: Drug: Bicalutamide; Drug: Placebo

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00672282

D6876C00025

7054IL/0025

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: 1,218 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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1,218 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Placebo

B

Active Comparator group

Treatment:

Drug: Bicalutamide