Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

Prostate Cancer Clinical Trial

Official title:

An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035997
• Other study ID #: CZOL446EUS24
• Secondary ID: US24
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2002
• Last updated: November 20, 2009
• Start date: April 2002
• Est. completion date: January 2004

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients.

This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria:

• 18 years of age or older

• Histologically confirmed diagnoses of prostate cancer

• Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph

• Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments

Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Signed informed consent

• Age > 18 years

• Histologically confirmed diagnosis of carcinoma of the prostate

• Objective evidence of metastatic disease to the bone as evidenced by bone scan or radiograph at any point since their diagnosis of prostate cancer

• Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist or other hormonal treatments for either < 6 months or > 6 months

• ECOG performance status of 0, 1, or 2

Exclusion criteria:

• Patients who are hormone sensitive without metastatic disease to the bone

• Patients who are hormone refractory typically defined as two or three consecutive increases in PSA measured at least one month apart while on hormone therapy

• Patients who are not treated with LHRH agonist or other hormonal treatments

• Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES

• Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.

• Patients with abnormal renal function as evidenced by either a serum creatinine greater than 2 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less

• Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zometa

Locations

Country	Name	City	State
United States	Advanced Urology Medical Center	Anaheim	California
United States	Alaska Clinical Research Center, LLC	Anchorage	Alaska
United States	Roger N. Andrews, MD Inc.	Arcadia	Pennsylvania
United States	Georgia Urology Research Institute	Atlanta	Georgia
United States	Urologic Surgery, PC	Bala Cynwyd	Pennsylvania
United States	Norwood Clinic	Birmingham	Alabama
United States	Boulder Medical Center	Boulder	Colorado
United States	James W. Thompson, MD Ltd.	Bryn Mawr	Pennsylvania
United States	Research Across America	Carrollton	Texas
United States	Cary Urology, P.A.	Cary	North Carolina
United States	CAMC Clinical Trials	Charleston	West Virginia
United States	The Urology Group	Cincinnati	Ohio
United States	Urological Associates PC	Davenport	Iowa
United States	Atlantic Urological Associates	Daytona Beach	Florida
United States	Urology Associates, P.C.	Denver	Colorado
United States	Urological Surgical Associates	Edison	New Jersey
United States	Southwest Florida Urologic Association	Fort Myers	Florida
United States	Urology Associates of Central CA	Fresno	California
United States	AccuMed Research Associates	Garden City	New York
United States	Urological Surgeons of Long Island PC	Garden City	New York
United States	Urology Center of the South P.C.	Germantown	Tennessee
United States	Drs. Werner, Murdock and Francis PA Urology Associates	Greenbelt	Maryland
United States	Matrix Research, LLC	Greenville	North Carolina
United States	Kansas City Urology Care	Kansas City	Missouri
United States	Kingston Urological Assoc.	Kingston	New York
United States	Center for Urological Research	La Mesa	California
United States	Diagnostic Clinic	Largo	Florida
United States	DMI Health Care Group, Inc.	Largo	Florida
United States	American Academy of Urology	Las Vegas	Nevada
United States	Atlantic Urological Medical Group	Long Beach	California
United States	Advanced Urology Medical Office	Los Angeles	California
United States	Advanced Urology Medical Offices	Los Angeles	California
United States	Marvin Stein, MD	Margate	Florida
United States	Urology Associates of Middlesex County, Inc.	Marlborough	Massachusetts
United States	Miami Cancer Institute	Miami	Florida
United States	Urology Institute of Pittsburgh	Monroeville	Pennsylvania
United States	UroResearch, LLC	Morristown	New Jersey
United States	Ball Memorial Hospital	Muncie	Indiana
United States	Murfreesboro Medical Clinic	Murfreesboro	Tennessee
United States	Grand Strand Urology	Myrtle Beach	South Carolina
United States	Urology Associates, PA	Nashville	Tennessee
United States	Advanced Research Institute	New Port Richey	Florida
United States	Florida Foundation for Healthcare Research	Ocala	Florida
United States	Urology Associates of Northeast Florida, PA	Orange Park	Florida
United States	Winter Park Urology Associates	Orlando	Florida
United States	Southwest Urology	Parma	Ohio
United States	Shaukat M. Qureshi, MD	Pennsville	New Jersey
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Lakeside Urology, P.C.	Saint Joseph	Michigan
United States	Millennium Medical Center	Southfield	Michigan
United States	The Prostate Center of Greater St. Louis	St. Louis	Missouri
United States	Pinellas Urology, Inc.	St. Petersburg	Florida
United States	Urology Associates	Stratford	New Jersey
United States	Southeastern Urological Center	Tallahassee	Florida
United States	Associates in Urology, LLC	West Orange	New Jersey
United States	Center for Urologic Care of Berks County	West Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months
Secondary	Changes in biochemical markers of bone turnover over 12 months
Secondary	Changes in bone mineral density of the total hip at 12 months
Secondary	Time to first skeletal-related event
Secondary	Overall safety measured by adverse events (AEs)