Know Cancer

or
forgot password

Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy.


Phase 4
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy.


Inclusion Criteria:



- Age ≥18

- histologically confirmed adenocarcinoma of the prostate.

- Orchidectomy within the four previous weeks to enter the study.

- bone metastasis evidenced by bone scan.

- A hip DEXA study with a DS < 3.

- No hormonal therapy previous to enter the study.

- ECOG performance score of 0-2.

- Signed written informed consent.

Exclusion Criteria:

- Abnormal renal function evidenced by a creatinine clearance ≤60 ml/min.

- Any kind of hormonal therapy for prostate cancer previous to enter the study.

- Serum calcium corrected for albumin level < 8.0 mg/dl.

- WBC < 3.0x10^3, ANC < 1500/mm3, Hemoglobin < 8.0 g/dl, platelets < 75 x 10^3/l.

- Abnormal hepatic function evidenced by ALT and AST value >2.5 UNL

- Subjects with any other malignant disease that can affect the bone.

- Subjects with any other non malignant disease that can jeopardize the evaluation of
the primary objectives of this trial (severe osteoporosis) or that do not aloud
perform the trial evaluations.

- Known hypersensibility to zoledronic acid or other bisphosphonates.

- Subjects that in the investigator's opinion can not cooperate with the protocol.

Other protocol inclusion/exclusion criteria may 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

Outcome Measure:

Evaluate the effects of Zometa® (Zoledronic Acid) i.v in doses of 4mg for measure the following parameters of efficacy: Quality of Life, Incidence of Events related to the skeleton

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Venezuela: Ministry of Health and Social Development

Study ID:

CZOL446EVE01

NCT ID:

NCT00237146

Start Date:

November 2003

Completion Date:

March 2008

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Zoledronic acid
  • Bone metastasis
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location