Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, 2 arm study.

The study population will consist of prostate cancer patients with metastatic bone disease for whom androgen-deprivation therapy is planned. After stratification based on the patient's age, performance status, and severity of metastatic disease, the patients will be randomized at a 1:1 ratio to the following treatment arms:

Daily oral risedronate combined with androgen deprivation
Daily oral placebo combined with androgen deprivation

Initial clinical evaluation will be performed during the 2-week screening period. While patients receive per-protocol treatment, study assessments will be performed every 4 weeks during the first 3 months, and every 12 weeks thereafter.

Performance Status: Eastern Cooperative Oncology Group (ECOG) 0 to 2

Life Expectancy: At least 12 weeks

Hematopoietic:

Absolute neutrophil count (ANC) > 1,000/mm3
Platelet count > 100,000/mm3
international normalized ratio (INR) < 1.5 x upper limit of normal unless on therapeutic anticoagulation
Partial thromboplastin time (PTT) < 1.5 x upper limit of normal unless on therapeutic anticoagulation

Hepatic:

Bilirubin < 1.5 mg/dL
Alanine transaminase (ALT) < 2.5 x upper limit of normal

Renal:

Creatinine clearance of > 30 mL/min (by Cockcroft-Gault)

Cardiovascular:

No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure).

Pulmonary:

Not specified

Calcium:

Corrected serum calcium = (4.0 g/dL - actual albumin g/dL)x 0.8 + serum calcium