Spots Global Cancer Trial Database for Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy
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Trial Identification
Brief Title: Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy
Official Title: A Phase III Randomized Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer
Study ID: NCT00329797
Study Description
Brief Summary: RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy. It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and hormone therapy.
Detailed Description: OBJECTIVES: Primary * Compare the potential benefit of bisphosphonate therapy comprising zoledronate plus vitamin D and calcium supplement vs standard therapy with vitamin D and calcium supplement in the prevention of osteoporosis and associated bone fractures in patients with locally advanced nonmetastatic adenocarcinoma of the prostate undergoing radiotherapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy. Secondary * Evaluate the potential benefit of these regimens on quality of life in these patients. * Evaluate the potential benefit in bone mineral density over a period of 3 years for patients treated with these regimens. OUTLINE: This is randomized multicenter study. Patients are stratified according to T score of the hip by dual x-ray absorptiometry (DXA) scan (\< -1.0 but \> -2.5 vs ≥ - 1.0) and planned duration of luteinizing hormone-releasing hormone (LHRH) agonist therapy (1-2½ years vs \> 2½ years). Patients are randomized to 1 of 2 treatment arms. Quality of life is assessed at baseline and every 6 months during treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Enloe Cancer Center at Enloe Medical Center, Chico, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center, Pomona, California, United States
Radiation Oncology Center - Roseville, Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center, Alton, Illinois, United States
Northwest Community Hospital, Arlington Heights, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois, United States
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields, Olympia Fields, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Center for Cancer Care at Goshen General Hospital, Goshen, Indiana, United States
Methodist Cancer Center at Methodist Hospital, Indianapolis, Indiana, United States
Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, United States
St. Agnes Hospital Cancer Center, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
CentraCare Clinic - River Campus, Saint Cloud, Minnesota, United States
Coborn Cancer Center, Saint Cloud, Minnesota, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Cape Girardeau, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Renown Institute for Cancer at Renown Regional Medical Center, Reno, Nevada, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden, Camden, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
Lourdes Regional Cancer Center, Binghamton, New York, United States
Veterans Affairs Medical Center - Brooklyn, Brooklyn, 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
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
Wayne Radiation Oncology, Goldsboro, North Carolina, United States
Cancer Centers of North Carolina - Raleigh, Raleigh, North Carolina, United States
Wilmed Radiation Oncology Services, Wilson, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem, Ohio, United States
Precision Radiotherapy at University Pointe, West Chester, Ohio, United States
Cancer Treatment Center, Wooster, Ohio, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Adams Cancer Center, Gettysburg, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center, York, Pennsylvania, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport, Tennessee, 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
LDS Hospital, Salt Lake City, Utah, United States
Norris Cotton Cancer Center - North, Saint Johnsbury, Vermont, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia, United States
Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States
Theda Care Cancer Institute, Appleton, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Community Memorial Hospital Cancer Care Center, Menomonee Falls, Wisconsin, United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee, Milwaukee, Wisconsin, United States
West Allis Memorial Hospital, West Allis, Wisconsin, United States
British Columbia Cancer Agency - Vancouver Island Centre, Victoria, British Columbia, Canada
Doctor H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada
Cancer Care Program at Thunder Bay Regional Health Sciences, Thunder Bay, Ontario, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada
CHUS-Hopital Fleurimont, Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Contact Details
Name: Colleen A. Lawton, MD
Affiliation: Medical College of Wisconsin
Role: PRINCIPAL_INVESTIGATOR
Name: Matthew R. Smith, MD
Affiliation: Massachusetts General Hospital
Role: STUDY_CHAIR
Name: Margaret Chamberlain-Wilmoth, PhD, MSS, RN
Affiliation: Carolinas Medical Center - University
Role: STUDY_CHAIR
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