Overview

Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Status:
Terminated
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
Male
Summary
Primary: To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently. Secondary Objectives: To describe the safety and tolerability at this dose and schedule
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stanford University
Collaborator:
Novartis
Treatments:
Diphosphonates
Zoledronic Acid
Criteria
Inclusion Criteria:Patients: Who are 18 years of age and older Who have histologically
documented adenocarcinoma of prostate Who are currently receiving LHRH agonists KPS greater
than 80%Life expectancy greater than 6 months Provide written consent pursuant to
regulatory requirements prior to initiation of study procedure Exclusion Criteria:Exclusion
Criteria: Patients: Any patient requiring continuous LHRH Any patient who has had an
orchiectomy Any patient with painful bone metastases Who have received chemotherapy for
prostate cancer Who have a abnormal serum creatine >2.5 Receiving any investigational drug
within the last 28 days Severe uncontrolled infection, diabetes, cardiac disease Patients
with fragility fractures, hyperparathyroidism, Pagets renal osteodystrophy will be excluded
History of non compliance to medical regimens or unwillingness to return for medical visits