CMAB vs IMAB in Metastatic Prostate Cancer

AstraZeneca

Status and phase: Withdrawn; Phase 4

Conditions: Metastatic Prostate Cancer

Treatments: Drug: Bicalutamide; Drug: Goserelin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00255268

D6876L00010

Details and patient eligibility

About

To evaluate the efficacy, safety and survival of two treatment regimens: Continuous Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated. QoL evaluation is also included.

Enrollment: 15 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological diagnosis of D2 of Adenocarcinoma,
• Naivety to treatment
• Valuable bone metastasis

Exclusion criteria

• Hematological, liver or renal toxicity Grade IV
• Severe and active infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)