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Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis Clinical research trials and Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis. Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis clinical trial. Subjects often receive the most expert healthcare possible for their Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.

Home > "O" Clinical Trials Conditions > Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis

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



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

For Condition: Prostate Cancer
Status: Completed
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry 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)
Total Enrollment: 200

Location and Contact Information:

Overall Study Official:
ScottPescatore,  Study Director,  Novartis Pharmaceuticals

Pinellas Urology, Inc.
St. Petersburg,  Florida,  33710
United States
 

CAMC Clinical Trials
Charleston,  West Virginia,  25304
United States
 

Marvin Stein, MD
Margate,  Florida,  33063
United States
 

Boulder Medical Center
Boulder,  Colorado, 
United States
 

James W. Thompson, MD Ltd.
Bryn Mawr,  Pennsylvania,  09010
United States
 

Urology Associates of Central CA
Fresno,  California,  93720
United States
 

Norwood Clinic
Birmingham,  Alabama,  35234
United States
 

Millennium Medical Center
Southfield,  Michigan,  48075
United States
 

Urological Associates PC
Davenport,  Iowa,  52807
United States
 

Matrix Research, LLC
Greenville,  North Carolina,  29607
United States
 

Cary Urology, P.A.
Cary,  North Carolina,  27511
United States
 

Shaukat M. Qureshi, MD
Pennsville,  New Jersey,  08070
United States
 

Roger N. Andrews, MD Inc.
Arcadia,  Pennsylvania,  91007
United States
 

Atlantic Urological Medical Group
Long Beach,  California,  90806
United States
 

Advanced Urology Medical Center
Anaheim,  California,  92801
United States
 

Urology Associates of Northeast Florida, PA
Orange Park,  Florida,  32073
United States
 

Grand Strand Urology
Myrtle Beach,  South Carolina,  29572
United States
 

Urology Associates, PA
Nashville,  Tennessee,  37209
United States
 

Kansas City Urology Care
Kansas City,  Missouri,  64131
United States
 

Urology Associates
Stratford,  New Jersey, 
United States
 

Urological Surgeons of Long Island PC
Garden City,  New York,  11530
United States
 

Alaska Clinical Research Center, LLC
Anchorage,  Alaska,  99508
United States
 

Urology Associates, P.C.
Denver,  Colorado,  80210
United States
 

American Academy of Urology
Las Vegas,  Nevada,  89119
United States
 

Florida Foundation for Healthcare Research
Ocala,  Florida,  34474
United States
 

Research Across America
Carrollton,  Texas,  75010
United States
 

Diagnostic Clinic
Largo,  Florida,  33770
United States
 

Kingston Urological Assoc.
Kingston,  New York,  12401
United States
 

Lakeside Urology, P.C.
Saint Joseph,  Michigan,  49085
United States
 

Albert Einstein Medical Center
Philadelphia,  Pennsylvania,  19141
United States
 

Urology Institute of Pittsburgh
Monroeville,  Pennsylvania,  15146
United States
 

Murfreesboro Medical Clinic
Murfreesboro,  Tennessee,  37130
United States
 

The Prostate Center of Greater St. Louis
St. Louis,  Missouri,  63136
United States
 

Advanced Urology Medical Office
Los Angeles,  California,  90045
United States
 

Urology Associates, P.C.
Denver,  Colorado,  80210
United States
 

Urologic Surgery, PC
Bala Cynwyd,  Pennsylvania,  19004
United States
 

Drs. Werner, Murdock and Francis PA Urology Associates
Greenbelt,  Maryland,  20770
United States
 

Florida Foundation for Healthcare Research
Ocala,  Florida,  34474
United States
 

Associates in Urology, LLC
West Orange,  New Jersey,  07052
United States
 

AccuMed Research Associates
Garden City,  New York,  11530
United States
 

Atlantic Urological Associates
Daytona Beach,  Florida,  32114
United States
 

DMI Health Care Group, Inc.
Largo,  Florida,  33773
United States
 

Center for Urological Research
La Mesa,  California,  91942
United States
 

Southwest Florida Urologic Association
Ft. Myers,  Florida, 
United States
 

Ball Memorial Hospital
Muncie,  Indiana,  47303
United States
 

Southeastern Urological Center
Tallahassee,  Florida,  32308
United States
 

Urological Surgical Associates
Edison,  New Jersey, 
United States
 

UroResearch, LLC
Morristown,  New Jersey,  07960
United States
 

The Urology Group
Cincinnati,  Ohio,  45212
United States
 

Center for Urologic Care of Berks County
West Reading,  Pennsylvania,  19611
United States
 

Advanced Research Institute
New Port Richey,  Florida,  34652
United States
 

Miami Cancer Institute
Miami,  Florida,  33143
United States
 

Urology Associates of Middlesex County, Inc.
Marlborough,  Massachusetts,  01752
United States
 

Advanced Urology Medical Offices
Los Angeles,  California,  90045
United States
 

Urology Center of the South P.C.
Germantown,  Tennessee,  38138
United States
 

Southwest Urology
Parma,  Ohio,  44129
United States
 

Georgia Urology Research Institute
Atlanta,  Georgia,  30342
United States
 

Winter Park Urology Associates
Orlando,  Florida,  32803
United States
 


Additional Information:
Study ID Numbers:
  CZOL446EUS24;  US24
Study Start Date: April 2002
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035997

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2. Gene-Environment Interaction in Prostate Cancer

3. Comparison Study of MDX-010 (CTLA-4) Alone and Combined with Docetaxel in the Treatment of Patients with Hormone Refractory Prostate Cancer

4. Perifosine to Treat Prostate Cancer

5. Reiki/Energy Healing in Prostate Cancer

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