Clinical trial NCT00035997: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Hormone-sensitive Prostate Cancer
Prostate Cancer
Bone Metastasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2002-05-08
Enrollment: 261
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months
Secondary outcomes:
measure: Changes in biochemical markers of bone turnover over 12 months
measure: Changes in bone mineral density of the total hip at 12 months
measure: Time to first skeletal-related event
measure: Overall safety measured by adverse events (AEs)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Norwood Clinic
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, LLC
state: Alaska
city: Anaheim
country: United States
facility: Advanced Urology Medical Center
state: California
city: Fresno
country: United States
facility: Urology Associates of Central CA
state: California
city: La Mesa
country: United States
facility: Center for Urological Research
state: California
city: Long Beach
country: United States
facility: Atlantic Urological Medical Group
state: California
city: Los Angeles
country: United States
facility: Advanced Urology Medical Offices
state: California
city: Los Angeles
country: United States
facility: Advanced Urology Medical Office
state: California
city: Boulder
country: United States
facility: Boulder Medical Center
state: Colorado
city: Denver
country: United States
facility: Urology Associates, P.C.
state: Colorado
city: Daytona Beach
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Fort Myers
country: United States
facility: Southwest Florida Urologic Association
state: Florida
city: Largo
country: United States
facility: Diagnostic Clinic
state: Florida
city: Largo
country: United States
facility: DMI Health Care Group, Inc.
state: Florida
city: Margate
country: United States
facility: Marvin Stein, MD
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Ocala
country: United States
facility: Florida Foundation for Healthcare Research
state: Florida
city: Orange Park
country: United States
facility: Urology Associates of Northeast Florida, PA
state: Florida
city: Orlando
country: United States
facility: Winter Park Urology Associates
state: Florida
city: St. Petersburg
country: United States
facility: Pinellas Urology, Inc.
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Urological Center
state: Florida
city: Atlanta
country: United States
facility: Georgia Urology Research Institute
state: Georgia
city: Muncie
country: United States
facility: Ball Memorial Hospital
state: Indiana
city: Davenport
country: United States
facility: Urological Associates PC
state: Iowa
city: Greenbelt
country: United States
facility: Drs. Werner, Murdock and Francis PA Urology Associates
state: Maryland
city: Marlborough
country: United States
facility: Urology Associates of Middlesex County, Inc.
state: Massachusetts
city: Saint Joseph
country: United States
facility: Lakeside Urology, P.C.
state: Michigan
city: Southfield
country: United States
facility: Millennium Medical Center
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Urology Care
state: Missouri
city: St. Louis
country: United States
facility: The Prostate Center of Greater St. Louis
state: Missouri
city: Las Vegas
country: United States
facility: American Academy of Urology
state: Nevada
city: Edison
country: United States
facility: Urological Surgical Associates
state: New Jersey
city: Morristown
country: United States
facility: UroResearch, LLC
state: New Jersey
city: Pennsville
country: United States
facility: Shaukat M. Qureshi, MD
state: New Jersey
city: Stratford
country: United States
facility: Urology Associates
state: New Jersey
city: West Orange
country: United States
facility: Associates in Urology, LLC
state: New Jersey
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Garden City
country: United States
facility: Urological Surgeons of Long Island PC
state: New York
city: Kingston
country: United States
facility: Kingston Urological Assoc.
state: New York
city: Cary
country: United States
facility: Cary Urology, P.A.
state: North Carolina
city: Greenville
country: United States
facility: Matrix Research, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Parma
country: United States
facility: Southwest Urology
state: Ohio
city: Arcadia
country: United States
facility: Roger N. Andrews, MD Inc.
state: Pennsylvania
city: Bala Cynwyd
country: United States
facility: Urologic Surgery, PC
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: James W. Thompson, MD Ltd.
state: Pennsylvania
city: Monroeville
country: United States
facility: Urology Institute of Pittsburgh
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: West Reading
country: United States
facility: Center for Urologic Care of Berks County
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Grand Strand Urology
state: South Carolina
city: Germantown
country: United States
facility: Urology Center of the South P.C.
state: Tennessee
city: Murfreesboro
country: United States
facility: Murfreesboro Medical Clinic
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates, PA
state: Tennessee
city: Carrollton
country: United States
facility: Research Across America
state: Texas
city: Charleston
country: United States
facility: CAMC Clinical Trials
state: West Virginia
Study officials:
affiliation: Novartis
name: Scott L. Pescatore, PharmD.
role: STUDY_DIRECTOR
References: