Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated Clinical Trial
Official title:
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
| Verified date | April 2012 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Hungary: National Institute of Pharmacy |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 43 |
| Est. completion date | |
| Est. primary completion date | April 2005 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |