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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00329797 |
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.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Prostate Cancer |
Drug: buserelin Drug: calcium carbonate Drug: calcium citrate Drug: calcium glucarate Drug: calcium gluconate Drug: cholecalciferol Drug: goserelin Drug: leuprolide acetate Drug: triptorelin Drug: zoledronic acid Procedure: brachytherapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized |
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 |
Estimated Enrollment: | 1272 |
Study Start Date: | March 2006 |
Arms | Assigned Interventions |
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Arm I: Experimental
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. Patients also undergo concurrent radiotherapy (external beam, brachytherapy, or both) and LHRH agonist (e.g., leuoprolide acetate, goserelin, buserelin, or triptorelin) therapy.
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Drug: buserelin
Given concurrently
Drug: calcium carbonate
Given orally
Drug: calcium citrate
Given orally
Drug: calcium glucarate
Given orally
Drug: calcium gluconate
Given orally
Drug: cholecalciferol
Given orally
Drug: goserelin
Given concurrently
Drug: leuprolide acetate
Given concurrently
Drug: triptorelin
Given concurrently
Drug: zoledronic acid
Given IV
Procedure: brachytherapy
Given concurrently
Procedure: radiation therapy
Given concurrently
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Arm II: Active Comparator
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. Patients also undergo concurrent radiotherapy (external beam, brachytherapy, or both) and LHRH agonist (e.g., leuoprolide acetate, goserelin, buserelin, or triptorelin) therapy.
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Drug: buserelin
Given concurrently
Drug: calcium carbonate
Given orally
Drug: calcium citrate
Given orally
Drug: calcium glucarate
Given orally
Drug: calcium gluconate
Given orally
Drug: cholecalciferol
Given orally
Drug: goserelin
Given concurrently
Drug: leuprolide acetate
Given concurrently
Drug: triptorelin
Given concurrently
Procedure: brachytherapy
Given concurrently
Procedure: radiation therapy
Given concurrently
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OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Any 1 of the following clinical stages:
Any T, any N, M0 with one of the following:
Planning to receive luteinizing hormone-releasing hormone (LHRH) agonist therapy
No distant metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Colleen A. Lawton, MD | Medical College of Wisconsin |
Investigator: | Matthew R. Smith, MD | Massachusetts General Hospital |
Investigator: | Margaret Chamberlain-Wilmoth, PhD, MSS, RN | Carolinas Medical Center - University |
Study ID Numbers: | CDR0000476469, RTOG-0518 |
Study First Received: | May 23, 2006 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00329797 |
Health Authority: | Unspecified |
osteoporosis adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Buserelin Cholecalciferol Zoledronic acid Genital Neoplasms, Male Prostatic Diseases Citric Acid Fractures, Bone Goserelin Osteoporosis Bone Diseases, Metabolic |
Urogenital Neoplasms Calcium Carbonate Genital Diseases, Male Bone Diseases Calcium, Dietary Musculoskeletal Diseases Triptorelin Leuprolide Adenocarcinoma Prostatic Neoplasms |
Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Contraceptive Agents Growth Substances Physiological Effects of Drugs Contraceptive Agents, Female Bone Density Conservation Agents Reproductive Control Agents Luteolytic Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Fertility Agents, Female Therapeutic Uses Vitamins Fertility Agents Antacids Micronutrients |