Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy
Osteoporosis, Prostate Cancer
About this trial
This is an interventional supportive care trial for Osteoporosis focused on measuring osteoporosis, adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
Eligibility Criteria
Eligibility criteria: Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 12 months of registration; Any one of the following clinical stages: T3 disease, any N stage, M0 with any Gleason score and any prostate-specific antigen (PSA); < T3 stage, any N stage, M0 with Gleason's score ≥ 8 and any PSA; < T3 stage, any N stage, M0 with Gleason's score 7 and PSA ≥ 15 nanograms/ml; < T3 stage, any N stage, M0 with Gleason score < 7 and PSA ≥ 20 nanograms/ml. A negative bone scan for metastatic disease; It is mandatory that the treating physician determine the planned duration of LHRH therapy prior to the site registering the patient (minimum 1 year of therapy); If patient is receiving pre-treatment LHRH therapy, it must have begun ≤ 6 months prior to registration. If pelvic radiation therapy (RT) has started, it must have begun ≤ 8 weeks prior to registration; Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup to be done within 16 weeks prior to registration: History/physical examination; Dental evaluation, including history of dental surgery (e.g., extraction or implant); Bone scan; T and L spine films; DXA scan: To be eligible the patient must have a scan on Lunar, Hologic, or Norland equipment only and the T scores in both the L spine and total hip must be > negative 2.5; Zubrod Performance Status 0-1 within 16 weeks prior to registration; (8/16/07) 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
Sites / Locations
- Enloe Cancer Center at Enloe Medical Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
- Radiation Oncology Center - Roseville
- Radiological Associates of Sacramento Medical Group, Incorporated
- Penrose Cancer Center at Penrose Hospital
- St. Mary - Corwin Regional Medical Center
- Northeast Georgia Medical Center
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Northwest Community Hospital
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
- CCOP - Carle Cancer Center
- Center for Cancer Care at Goshen General Hospital
- Methodist Cancer Center at Methodist Hospital
- Lucille P. Markey Cancer Center at University of Kentucky
- St. Agnes Hospital Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- West Michigan Cancer Center
- CentraCare Clinic - River Campus
- Coborn Cancer Center
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- CCOP - Kansas City
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Northern Rockies Radiation Oncology Center
- Great Falls Clinic - Main Facility
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Renown Institute for Cancer at Renown Regional Medical Center
- Kingsbury Center for Cancer Care at Cheshire Medical Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- Cancer Institute of New Jersey at Cooper - Voorhees
- Lourdes Regional Cancer Center
- Veterans Affairs Medical Center - Brooklyn
- Roswell Park Cancer Institute
- CCOP - Hematology-Oncology Associates of Central New York
- Mission Hospitals - Memorial Campus
- Wayne Radiation Oncology
- Cancer Centers of North Carolina - Raleigh
- Wilmed Radiation Oncology Services
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Charles M. Barrett Cancer Center at University Hospital
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
- Precision Radiotherapy at University Pointe
- Cancer Treatment Center
- Rosenfeld Cancer Center at Abington Memorial Hospital
- Bryn Mawr Hospital
- Adams Cancer Center
- Cancer Center of Paoli Memorial Hospital
- Fox Chase Cancer Center - Philadelphia
- Lankenau Cancer Center at Lankenau Hospital
- York Cancer Center at Apple Hill Medical Center
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- LDS Hospital
- Norris Cotton Cancer Center - North
- Sentara Cancer Institute at Sentara Norfolk General Hospital
- Naval Medical Center - Portsmouth
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Theda Care Cancer Institute
- St. Vincent Hospital Regional Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Community Memorial Hospital Cancer Care Center
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
- Medical College of Wisconsin Cancer Center
- Veterans Affairs Medical Center - Milwaukee
- West Allis Memorial Hospital
- British Columbia Cancer Agency - Vancouver Island Centre
- Doctor H. Bliss Murphy Cancer Centre
- Margaret and Charles Juravinski Cancer Centre
- Cancer Care Program at Thunder Bay Regional Health Sciences
- Maisonneuve-Rosemont Hospital
- Centre Hospitalier Universitaire de Quebec
- CHUS-Hopital Fleurimont
- Allan Blair Cancer Centre at Pasqua Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Zoledronic Acid
Control
Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.