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

NCT00237146 | Completed Phase 4

• 1 other identifier: CZOL446EVE01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Zoledronic acid; Bone metastasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Zoledronic Acid

EXPERIMENTAL

Drug: Zoledronic acid

Interventions

Zoledronic acid DRUG

Also known as: ZOL446

Zoledronic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Caracas, Venezuela

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2005
• First Posted: October 12, 2005
• Study Start: November 1, 2003
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

VE (1)