Spots Global Cancer Trial Database for Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
Official Title: A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone
Study ID: NCT00079001
Study Description
Brief Summary: RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases. PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.
Detailed Description: Zoledronic acid decreases the risk of skeletal related events in men with prostate cancer metastatic to bone and disease progression after primary hormonal therapy. This study is designed to evaluate whether earlier treatment with zoledronic acid will further decrease the risk of skeletal related events. This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior skeletal-related event (no vs yes), and serum alkaline phosphatase (\< upper limit of normal \[ULN\] vs ≥ ULN). The primary objective of the study is to determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event. The secondary objective of the study is to compare the effect of treatment with zoledronic acid to placebo on overall survival (OS), progression-free survival (PFS) and toxicity in men receiving androgen deprivation therapy for metastatic prostate cancer. Patients are randomized to 1 of 2 treatment arms. Treatment continues in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy with a GnRH agonist. Patients also receive oral calcium and (vitamin D) supplements daily. Patients progressing to androgen-independent prostate cancer proceed to the open-label therapy with zoledronic acid IV. Treatment continues for 3 weeks in the absence of disease progression or the first skeletal-related event. Patients are followed periodically for approximately 10 years after entry on the study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Providence Cancer Center at Providence Hospital, Mobile, Alabama, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center, Fort Smith, Arkansas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda, California, United States
, Pismo Beach, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center, Pomona, California, United States
Saint Helena Hospital, Saint Helena, California, United States
Salinas Valley Memorial Hospital, Salinas, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital, Whittier, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Veterans Affairs Medical Center - West Haven, West Haven, Connecticut, United States
Kaiser Permanente at Capitol Hill Medical Center, Washington, District of Columbia, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Leesburg Regional Medical Center, Leesburg, Florida, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler, Savannah, Georgia, United States
Kapiolani Medical Center at Pali Momi, 'Aiea, Hawaii, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana, Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated, Honolulu, Hawaii, United States
Hawaii Medical Center - East, Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Pacific Cancer Institute - Maui, Wailuku, Hawaii, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago Westside Hospital, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
Elmhurst Memorial Hospital, Elmhurst, Illinois, United States
Veterans Affairs Medical Center - Hines, Hines, Illinois, United States
Provena St. Mary's Regional Cancer Center - Kankakee, Kankakee, Illinois, United States
La Grange Memorial Hospital, La Grange, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Elkhart Clinic, LLC, Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
William N. Wishard Memorial Hospital, Indianapolis, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte, Westville, Indiana, United States
Heartland Oncology and Hematology, Council Bluffs, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Veterans Affairs Medical Center - Iowa City, Iowa City, Iowa, United States
Covenant Cancer Treatment Center, Waterloo, Iowa, United States
Cotton-O'Neil Cancer Center, Topeka, Kansas, United States
Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States
Louisiana State University Health Sciences Center - Monroe, Monroe, Louisiana, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans, New Orleans, Louisiana, United States
Highland Clinic, Shreveport, Louisiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland, United States
Union Memorial Hospital, Baltimore, Maryland, United States
Good Samaritan Hospital of Maryland, Baltimore, Maryland, United States
Kaiser Permanente at Woodlawn Medical Center, Baltimore, Maryland, United States
Shore Regional Cancer Center at Memorial Hospital - Easton, Easton, Maryland, United States
John R. Marsh Cancer Center at Washington County Hospital, Hagerstown, Maryland, United States
Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility, Largo, Maryland, United States
Kaiser Permanente Capital Area Medical Group - Shady Grove Facility, Rockville, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Lowell General Hospital, Lowell, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center, Milford, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States
Dickinson County Healthcare System, Iron Mountain, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Community Cancer Center of Monroe, Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe, Monroe, Michigan, United States
Michiana Hematology Oncology PC - Niles, Niles, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller - Dwan Medical Center, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
St. James Healthcare Cancer Care, Butte, Montana, United States
Big Sky Oncology, Great Falls, Montana, United States
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center, Grand Island, Nebraska, United States
Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney, Nebraska, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
Callahan Cancer Center at Great Plains Regional Medical Center, North Platte, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
Immanuel Medical Center, Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska, United States
Lakeside Hospital, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care, Concord, New Hampshire, United States
Center for Cancer Care at Exeter Hospital, Exeter, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett, Hooksett, New Hampshire, United States
Dana-Farber Cancer Institute at Londonderry, Londonderry, New Hampshire, United States
Elliot Regional Cancer Center at Elliot Hospital, Manchester, New Hampshire, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland, New Jersey, United States
Lovelace Medical Center - Downtown, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Kings County Hospital Center, Brooklyn, New York, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States
New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
Southeastern Regional Medical Center, Lumberton, North Carolina, United States
Granville Medical Center, Oxford, North Carolina, United States
Duke Health Raleigh Hospital, Raleigh, North Carolina, United States
Person Memorial Hospital, Roxboro, North Carolina, United States
Wood County Oncology Center, Bowling Green, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
St. Rita's Medical Center, Lima, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Northwest Ohio Oncology Center, Maumee, Ohio, United States
Fisher-Titus Medical Center, Norwalk, Ohio, United States
St. Charles Mercy Hospital, Oregon, Ohio, United States
Toledo Clinic - Oregon, Oregon, Ohio, United States
North Coast Cancer Care, Incorporated, Sandusky, Ohio, United States
Flower Hospital Cancer Center, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
St. Vincent Mercy Medical Center, Toledo, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
St. Anne Mercy Hospital, Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Bay Area Hospital, Coos Bay, Oregon, United States
Kaiser Permanente Health Care - Portland, Portland, Oregon, United States
Mercy Hospital Cancer Center - Scranton, Scranton, Pennsylvania, United States
Susquehanna Cancer Center at Divine Providence Hospital, Williamsport, Pennsylvania, United States
Greenville Hospital Cancer Center, Greenville, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
Self Regional Cancer Center at Self Regional Medical Center, Greenwood, South Carolina, United States
MBCCOP - Meharry Medical College - Nashville, Nashville, Tennessee, United States
Baylor University Medical Center - Houston, Houston, Texas, United States
Ben Taub General Hospital, Houston, Texas, United States
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital, Houston, Texas, United States
Veterans Affairs Medical Center - Houston, Houston, Texas, United States
American Fork Hospital, American Fork, Utah, United States
Sandra L. Maxwell Cancer Center, Cedar City, Utah, United States
Logan Regional Hospital, Logan, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo, Provo, Utah, United States
Dixie Regional Medical Center - East Campus, Saint George, Utah, United States
Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, United States
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
Mountainview Medical, Berlin, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Kaiser Permanente Medical Center - Fair Oaks, Fairfax, Virginia, United States
Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia, United States
Lynchburg Hematology-Oncology Clinic, Lynchburg, Virginia, United States
Island Hospital Cancer Care Center at Island Hospital, Anacortes, Washington, United States
St. Joseph Cancer Center, Bellingham, Washington, United States
Olympic Hematology and Oncology, Bremerton, Washington, United States
Highline Medical Center Cancer Center, Burien, Washington, United States
Columbia Basin Hematology, Kennewick, Washington, United States
Skagit Valley Hospital Cancer Care Center, Mount Vernon, Washington, United States
Minor and James Medical, PLLC, Seattle, Washington, United States
Group Health Central Hospital, Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
North Puget Oncology at United General Hospital, Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Rockwood Clinic Cancer Treatment Center, Spokane, Washington, United States
Evergreen Hematology and Oncology, PS, Spokane, Washington, United States
Wenatchee Valley Medical Center, Wenatchee, Washington, United States
Langlade Memorial Hospital, Antigo, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Wheaton Franciscan Cancer Care - St. Joseph, Milwaukee, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
St. Nicholas Hospital, Sheboygan, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital, Wausau, Wisconsin, United States
Riverview UW Cancer Center at Riverview Hospital, Wisconsin Rapids, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
University of British Columbia, Vancouver, British Columbia, Canada
London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada
Contact Details
Name: Matthew R. Smith, MD, PhD
Affiliation: Massachusetts General Hospital
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
