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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


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Osteoporosis, Prostate Cancer

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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 InstituteBuffalo, New York  14263
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Northwest Community HospitalArlington Heights, Illinois  60005
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
LDS HospitalSalt Lake City, Utah  84143
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Lourdes Regional Cancer CenterBinghamton, New York  13905
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
Northeast Georgia Medical CenterGainesville, Georgia  30501
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
West Allis Memorial HospitalWest Allis, Wisconsin  53227
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Enloe Cancer Center at Enloe Medical CenterChico, California  95926
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical CenterPomona, California  91767
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Wilmed Radiation Oncology ServicesWilson, North Carolina  27893
Theda Care Cancer InstituteAppleton, Wisconsin  54911
Community Memorial Hospital Cancer Care CenterMenomonee Falls, Wisconsin  53051
Sentara Cancer Institute at Sentara Norfolk General HospitalNorfolk, Virginia  23507
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia FieldsOlympia Fields, Illinois  60461
Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295
Cancer Institute of New Jersey at Cooper University Hospital - CamdenCamden, New Jersey  08103
Cancer Centers of North Carolina - RaleighRaleigh, North Carolina  27607
Precision Radiotherapy at University PointeWest Chester, Ohio  45069
Radiation Oncology Center - RosevilleRoseville, California  95661
St. Agnes Hospital Cancer CenterBaltimore, Maryland  21229
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502
Norris Cotton Cancer Center - NorthSaint Johnsbury, Vermont  05819
Adams Cancer CenterGettysburg, Pennsylvania  17325