Status:
COMPLETED
A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer
Eligibility Criteria
Inclusion
- Written informed consent must be obtained
- Age \> 18 years
- Histologically confirmed diagnosis of carcinoma of the prostate
- Current (or previous) objective evidence of metastatic disease to the bone
- Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments
- ECOG performance status of 0, 1, or 2
Exclusion
- Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less
- Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L)
- WBC\<3.0x1'000'000'000, ANC \< 1500/mm3, Hgb\<8.0 g/dL, platelets \< 75 x 1'000'000'000/L.
- Liver function tests \>2.5 ULN, serum creatinine \>1.5 ULN.
- Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
- Known hypersensitivity to zoledronic acid or other bisphosphonates
- Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
- Other protocol-defined inclusion / exclusion criteria apply.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00172016
Start Date
January 1 2004
Last Update
April 30 2012
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