Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy
NCT ID: NCT00329797
Last Updated: 2017-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
109 participants
INTERVENTIONAL
2006-03-31
2014-11-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Zoledronic Acid
Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Zoledronic acid
Patients receive IV over 15 minutes once every 6 months for 3 years. The goal dose of zoledronic acid is 4 mg, but the selection of dose is determined based on calculated creatinine clearance at baseline.
radiation therapy
Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.
LHRH
LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.
Vitamin D
400 IU (10μg), orally each day for 3 years.
Control
Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
radiation therapy
Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.
LHRH
LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.
Vitamin D
400 IU (10μg), orally each day for 3 years.
Interventions
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Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Zoledronic acid
Patients receive IV over 15 minutes once every 6 months for 3 years. The goal dose of zoledronic acid is 4 mg, but the selection of dose is determined based on calculated creatinine clearance at baseline.
radiation therapy
Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.
LHRH
LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.
Vitamin D
400 IU (10μg), orally each day for 3 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18;
* Serum creatinine within 4 weeks prior to registration (8/16/07)
* Corrected serum calcium ≥ 8.4 and ≤ 10.6 mg/dl within 8 weeks prior to registration; note: for patients with an albumin of 4.0, corrected calcium=measured calcium. The formula for corrected calcium if serum albumin value is above or below 4.0 is as follows: Corrected calcium (mg/dl) = (4 - \[patient's albumin (g/dl)\] x 0.8) + patient's measured calcium (mg/dl)
* Patients who are sexually active must be willing/able to use medically acceptable forms of contraception, as the treatment involved in this study may be significantly teratogenic.
* Patient agrees to refrain from using all products listed in Section 9.2, "Non-permitted Supportive Therapy";
* Post-prostatectomy patients are eligible.
* Patient must sign study specific informed consent prior to study entry.
Ineligibility criteria:
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; e.g., carcinoma in situ of the breast or oral cavity are permissible;
* Patients with baseline T scores of ≤ -2.5 are excluded.
* Patients with baseline calculated creatinine clearance \< 30 mL/min (estimated by Cockcroft-Gault formula below) are excluded. creatinine clearance male = \[(140 - age) x (wt in kg)\] / \[(serum creatinine) x (72)\]
* Prior bisphosphonate therapy;
* Prior pelvic radiation (other than for current prostate cancer) or prior systemic radiotherapeutic agents, such as strontium or samarium;
* Patients receiving systemic chemotherapy, steroids, growth hormones, or calcitonin;
* Patients with a history of Paget's disease or with uncontrolled thyroid or parathyroid dysfunction or with other diseases that influence bone metabolism;
* Known hypersensitivity to zoledronic acid or other bisphosphonates;
* Active dental problems at study entry, including infection of the teeth or jawbone; dental or fixture trauma; or a current or prior diagnosis of osteonecrosis of the jaw, exposed bone in the mouth, or slow healing after dental procedures;
* Recent or planned
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Colleen A. Lawton, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Matthew R. Smith, MD
Role: STUDY_CHAIR
Massachusetts General Hospital
Margaret Chamberlain-Wilmoth, PhD, MSS, RN
Role: STUDY_CHAIR
Carolinas Medical Center - University
Locations
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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
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, 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 Township, 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
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, 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
Québec, Quebec, Canada
CHUS-Hopital Fleurimont
Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Countries
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Other Identifiers
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CDR0000476469
Identifier Type: -
Identifier Source: secondary_id
NCI-2009-00884
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG 0518
Identifier Type: -
Identifier Source: org_study_id