Trial Information

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy: Hoosier Oncology Group GU02-41

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: ECOG 0 to 2

Life Expectancy: At least 12 weeks

Hematopoietic:

- ANC > 1,000/mm3

- Platelet count > 100,000/mm3

- 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