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

Prostate Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237146
• Other study ID #: CZOL446EVE01
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2005
• Last updated: February 21, 2017
• Start date: November 2003
• Est. completion date: March 2008

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
Venezuela	Novartis Investigative Site	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Results for CZOL446EVE01 from the Novartis Clinical Trials website