A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, COMPARATIVE, SAFETY AND EFFICACY STUDY OF INTRAVENOUS ZOLEDRONATE (4 AND 8 MG) IN PROSTATE CANCER PATIENTS WITH METASTATIC BONE LESIONS RACEIVING ANTINEOPLASTIC THERAPY

Not Applicable

• Conditions: -C61 Malignant neoplasm of prostate; Malignant neoplasm of prostate; C61

• Registration Number: PER-011-99
• Lead Sponsor: OVARTIS BIOSCIENSES PERÚ S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-09-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•Signed informed consent.
•Patients 18 years of age or greater.
•A histologically confírmed diagnosis of carcinoma of the prostate.
•Patients must have or have had objective evidence of metastatic disease to bone. Objective evidence of metastatic bone disease is defined as múltiple foci (> 3) of increased activity on bone sean. If there are < 3 foci of increased activity on bone sean, additional radiographic or biopsy studies are required to confirm the presence of osteoblastic or osteolytic malignant bone lesions. Patients who have achieved a complete response to first-Iine hormonal therapy and their current bone sean is normal are still eligible to enroll in this study as long as bone metastases have been documented previously during the patient´s clinical course.

Exclusion Criteria

•Bone pain due to metastatic bone disease that has developed since the best response to first-line hormonal therapy for metastatic disease.
•Previous or current (prior to and including Visit 2) treatment with cytotoxic chemotherapy (subsequent use of cytotoxic chemotherapy during the study is permitted).
•Alteration of the first-line hormonal therapy to a second-line hormonal regimen prior to Visit 1 (subsequent alteration of the patient hormonal therapy during Visit 1 or throughout the study is not an exclusión criterio or a protocol violation).
•Serum testosterone level (at Visit 1) elevated above the cástrate range (> 50 ng/ml).
•Radiation therapy to bone (including radioisotopes) within 3 months prior to Visit 2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified