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
18 Years
N/A
Male
Osteoporosis, Prostate Cancer
Trial Information
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
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.
- Arm I: Parents receive zoledronate IV over 15 minutes once every 6 months. Patients
also receive oral calcium and oral cholecaliciferol (vitamin D) once daily. Treatment
continues for 3 years in the absence of bone fractures, disease progression, or
unacceptable toxicity.
- Arm II: Patients receive oral calcium and oral vitamin D once daily. Treatment
continues for 3 years in the absence of bone fractures, disease progression, or
unacceptable toxicity.
All patients also undergo concurrent radiotherapy (external beam, brachytherapy, or both)
and LHRH agonist (e.g., leuoprolide acetate, goserelin, buserelin, or triptorelin) therapy.
Quality of life is assessed at baseline and every 6 months during treatment.
PROJECTED ACCRUAL: A total of 1,272 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Diagnosed within the past 12 months
- Any 1 of the following clinical stages:
- Clinical stage T3, any N, M0 with any Gleason score and any prostate-specific
antigen (PSA)
- Any T, any N, M0 with one of the following:
- Gleason score ≥ 8 and any PSA
- Gleason score 7 and PSA ≥ 15 ng/mL
- Gleason score < 7 and PSA ≥ 20 ng/mL
- Baseline T score > -2.5 in both the L spine and the total hip by dual x-ray
absorptiometry (DXA) scan
- Planning to receive luteinizing hormone-releasing hormone (LHRH) agonist therapy
- If patient is receiving LHRH therapy before study entry, therapy must have begun
≤ 6 months prior to study entry
- Scheduled to receive a LHRH agonist for ≥ 1 year
- Planning to undergo radiotherapy (i.e., external-beam, brachytherapy, or both)
- No distant metastases
- Must have negative bone scan for metastatic disease
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Creatinine clearance > 30 mL/min
- Calcium 8.4-10.6 mg/dL
- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment
- No history of Paget's disease
- No uncontrolled thyroid or parathyroid dysfunction
- No known hypersensitivity to zoledronate or other bisphosphonates
- No infection of the teeth or jawbone
- No dental or fixture trauma
- No current or prior diagnosis of osteonecrosis of the jaw
- No exposed bone in the mouth
- No slow healing after dental procedures
- No other active dental problems
- No other diseases that influence bone metabolism
- No other malignancy within the past 3 years except nonmelanomatous skin cancer or
carcinoma in situ of the breast or oral cavity
PRIOR CONCURRENT THERAPY:
- See Disease Characterisitics
- More than 6 weeks since prior dental or jaw surgery (e.g., extraction, implants)
- No prior bisphosphonate therapy
- No prior pelvic radiation
- No prior systemic radiotherapeutic agents, such as strontium chloride Sr 89 or
samarium Sm 153 lexidronam pentasodium
- No concurrent systemic chemotherapy
- No concurrent steroids
- No concurrent growth hormones
- No concurrent calcitonin
- No concurrent dental or jaw surgery
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
Freedom from any bone fracture
Safety Issue:
No
Principal Investigator
Colleen A. Lawton, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Medical College of Wisconsin
Authority:
United States: Federal Government
Study ID:
CDR0000476469
NCT ID:
NCT00329797
Start Date:
March 2006
Completion Date:
Related Keywords:
- Osteoporosis
- Prostate Cancer
- osteoporosis
- adenocarcinoma of the prostate
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- Osteoporosis
- Prostatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
| St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
| Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana 46202 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| Northwest Community Hospital | Arlington Heights, Illinois 60005 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee, Wisconsin 53201-2901 |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
| Naval Medical Center - Portsmouth | Portsmouth, Virginia 23708-2197 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
| Lourdes Regional Cancer Center | Binghamton, New York 13905 |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
| David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
| CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
| Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
| Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
| Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| West Allis Memorial Hospital | West Allis, Wisconsin 53227 |
| Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
| Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
| York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
| Enloe Cancer Center at Enloe Medical Center | Chico, California 95926 |
| Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona, California 91767 |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
| Wilmed Radiation Oncology Services | Wilson, North Carolina 27893 |
| Theda Care Cancer Institute | Appleton, Wisconsin 54911 |
| Community Memorial Hospital Cancer Care Center | Menomonee Falls, Wisconsin 53051 |
| Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |
| Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland, New Jersey 08360 |
| Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
| Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields | Olympia Fields, Illinois 60461 |
| Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
| Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden, New Jersey 08103 |
| Cancer Centers of North Carolina - Raleigh | Raleigh, North Carolina 27607 |
| Precision Radiotherapy at University Pointe | West Chester, Ohio 45069 |
| Radiation Oncology Center - Roseville | Roseville, California 95661 |
| St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
| Renown Institute for Cancer at Renown Regional Medical Center | Reno, Nevada 89502 |
| Norris Cotton Cancer Center - North | Saint Johnsbury, Vermont 05819 |
| Adams Cancer Center | Gettysburg, Pennsylvania 17325 |
