Know Cancer

or
forgot password

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


Phase 4
18 Years
N/A
Not Enrolling
Male
Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Hungary: National Institute of Pharmacy

Study ID:

CZOL446EHU01

NCT ID:

NCT00172016

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated
  • Zoledronic acid
  • SRE
  • Prostate cancer
  • Prostatic Neoplasms

Name

Location