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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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
Venezuela
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Zoledronic acid, Bone metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zoledronic Acid

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 9, 2005
Last Updated
February 21, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00237146
Brief Title
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
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Zoledronic acid, Bone metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic Acid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
ZOL446
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Caracas
Country
Venezuela

12. IPD Sharing Statement

Learn more about this trial

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

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