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

Novartis

Status and phase

Completed

Phase 4

Conditions

Prostate Cancer

Treatments

Drug: Zoledronic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00237146

CZOL446EVE01

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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.