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

Completed · Phase 4

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00035997

Run by

Novartis Pharmaceuticals

People needed

261

Starts

2002-04-01

Expected to finish

2004-01-01

Last updated by the study team

2009-11-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Alaska Clinical Research Center, LLC — Anchorage, Alaska, United States
• Advanced Urology Medical Center — Anaheim, California, United States
• Urology Associates of Central CA — Fresno, California, United States
• Center for Urological Research — La Mesa, California, United States
• Atlantic Urological Medical Group — Long Beach, California, United States
• Advanced Urology Medical Offices — Los Angeles, California, United States
• Advanced Urology Medical Office — Los Angeles, California, United States
• Boulder Medical Center — Boulder, Colorado, United States
• Urology Associates, P.C. — Denver, Colorado, United States
• Atlantic Urological Associates — Daytona Beach, Florida, United States
• Southwest Florida Urologic Association — Fort Myers, Florida, United States
• Diagnostic Clinic — Largo, Florida, United States
• DMI Health Care Group, Inc. — Largo, Florida, United States
• Marvin Stein, MD — Margate, Florida, United States
• Miami Cancer Institute — Miami, Florida, 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
• Pinellas Urology, Inc. — St. Petersburg, Florida, United States
• Southeastern Urological Center — Tallahassee, Florida, United States
• Georgia Urology Research Institute — Atlanta, Georgia, United States
• Ball Memorial Hospital — Muncie, Indiana, United States
• Urological Associates PC — Davenport, Iowa, United States
• Norwood Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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