Prostate Cancer Clinical Trial
Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer
Summary
RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without estrogen and/or risedronate in preventing osteoporosis.
PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy.
Full Description
OBJECTIVES:
Compare the change in bone mineral density in patients with prostate cancer who are receiving androgen-ablation therapy treated with calcium and cholecalciferol with or without conjugated estrogens and with or without risedronate.
Compare the toxicity of these regimens in these patients.
Compare the changes in bone markers in patients treated with these regimens.
Compare the quality of life of patients treated with these regimens.
Compare hot flashes in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to duration of therapy with luteinizing hormone-releasing hormone agonists (no more than 30 days vs 31 to 150 days vs 151 to 365 days vs more than 365 days). Patients are randomized to 1 of 4 treatment arms.
Arm I: Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo daily.
Arm II: Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo daily.
Arm III: Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo daily.
Arm IV: Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
PROJECTED ACCRUAL: A total of 282 patients (70 per treatment arm) will be accrued for this study within 14 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
History of prostate cancer
No evidence of metastatic bony disease* NOTE: *Elevated prostate-specific antigen (PSA) allowed
Meets one of the following criteria:
Currently on treatment with androgen-ablation therapy in the adjuvant setting
Rising PSA without other evidence of recurrent disease with planned treatment for at least 6 months
No known osteoporosis or prior osteoporotic fracture
Osteoporosis defined as bone density at the hip or spine of more than 2.5 standard deviations below the mean for young men
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Not specified
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
SGOT or SGPT no greater than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase normal OR no greater than 1.5 times ULN with a normal bone scan
Renal
Creatinine no greater than 1.5 times ULN
No prior symptomatic hypercalcemia or hypocalcemia
Cardiovascular
No active heart disease
No congestive heart failure under active treatment
No myocardial infarction within the past 5 years
No coronary artery disease (CAD) with recent myocardial infarction
Patients with a remote history of CAD who are only on medical treatment (e.g., antilipid agents) are allowed
No prior thrombosis (deep vein thrombosis, stroke, or pulmonary embolism) or other known hypercoagulable state other than cancer
Other
Fertile patients must use effective contraception
Triglycerides no greater than 250 mg/dL (treatment allowed)
Able to complete questionnaire(s) by self or with assistance
Able to swallow pills
No prior hyperlipidemia (e.g., prior familial hyperlipidemia or fasting triglyceride greater than 250 mg/dL within the past 6 months)
No sarcoidosis
No parathyroid dysfunction
No intolerance to bisphosphonates
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
No concurrent chemotherapy
Endocrine therapy
See Disease Characteristics
No concurrent systemic steroids
Radiotherapy
No concurrent radiotherapy
Surgery
More than 3 months since prior and no concurrent dental extraction, root canal, or dental implantation
Other
No prior bisphosphonates
More than 5 years since prior percutaneous transluminal coronary angioplasty
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There are 90 Locations for this study
Scottsdale Arizona, 85259, United States
Jacksonville Florida, 32224, United States
Aurora Illinois, 60507, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Joliet Illinois, 60435, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61603, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Spring Valley Illinois, 61362, United States
Spring Valley Illinois, 61362, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Michigan City Indiana, 46360, United States
Ames Iowa, 50010, United States
Carroll Iowa, 51401, United States
Council Bluffs Iowa, 51503, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Mason City Iowa, 50401, United States
Missouri Valley Iowa, 51555, United States
Onawa Iowa, 51040, United States
Ottumwa Iowa, 52501, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
West Des Moines Iowa, 50266, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Brainerd Minnesota, 56401, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Minneapolis Minnesota, 55403, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
St. Cloud Minnesota, 56303, United States
St. Louis Park Minnesota, 55416, United States
St. Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Billings Montana, 59101, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Fremont Nebraska, 68025, United States
Lincoln Nebraska, 68502, United States
Lincoln Nebraska, 68510, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68131, United States
Papillion Nebraska, 68046, United States
Rutherfordton North Carolina, 28139, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Grand Forks North Dakota, 58201, United States
Tulsa Oklahoma, 74136, United States
Danville Pennsylvania, 17822, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Anderson South Carolina, 29621, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29304, United States
Sioux Falls South Dakota, 57104, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Regina Saskatchewan, S4T 1, Canada
Regina Saskatchewan, S4T 7, Canada
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