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.

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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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

71

Study ID:

NCT00043069

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 90 Locations for this study

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CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
St. Joseph Medical Center
Bloomington Illinois, 61701, United States
Graham Hospital
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Eureka Hospital
Eureka Illinois, 61530, United States
Galesburg Clinic
Galesburg Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex
Hopedale Illinois, 61747, United States
Joliet Oncology Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Kewanee Hospital
Kewanee Illinois, 61443, United States
McDonough District Hospital
Macomb Illinois, 61455, United States
BroMenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center
Normal Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61603, United States
Proctor Hospital
Peoria Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria Illinois, 61615, United States
OSF St. Francis Medical Center
Peoria Illinois, 61637, United States
Illinois Valley Community Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley Illinois, 61362, United States
Valley Cancer Center
Spring Valley Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
McFarland Clinic, P.C.
Ames Iowa, 50010, United States
Saint Anthony Regional Hospital
Carroll Iowa, 51401, United States
Alegent Health Mercy Hospital
Council Bluffs Iowa, 51503, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City Iowa, 50401, United States
Alegent Health Community Memorial Hospital
Missouri Valley Iowa, 51555, United States
Burgess Health Center
Onawa Iowa, 51040, United States
Cancer Center at Ottumwa Regional Health Center
Ottumwa Iowa, 52501, United States
Siouxland Regional Cancer Center
Sioux City Iowa, 51101, United States
Siouxland Hematology-Oncology Associates
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines Iowa, 50266, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons Kansas, 67357, United States
Pratt Cancer Center of Kansas
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health
Wichita Kansas, 67203, United States
Cancer Center of Kansas, P.A.
Wichita Kansas, 67208, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
Brainerd Medical Center
Brainerd Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller-Dwan Medical Center
Duluth Minnesota, 55805, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota, 55805, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
Fridley Minnesota, 55432, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis Minnesota, 55403, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
CentraCare Clinic - River Campus
St. Cloud Minnesota, 56303, United States
Park Nicollet Clinic
St. Louis Park Minnesota, 55416, United States
United Hospital
St. Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
Sletten Regional Cancer Institute
Great Falls Montana, 59405, United States
Fremont Area Medical Center
Fremont Nebraska, 68025, United States
Bryan LGH Medical Center West
Lincoln Nebraska, 68502, United States
Cancer Resource Center - Lincoln
Lincoln Nebraska, 68510, United States
St. Elizabeth Regional Medical Center
Lincoln Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Immanuel Medical Center
Omaha Nebraska, 68122, United States
Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Cancer Center at Creighton University Medical Center
Omaha Nebraska, 68131, United States
Midlands Cancer Center at Midlands Community Hospital
Papillion Nebraska, 68046, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Bismarck Cancer Center
Bismarck North Dakota, 58501, United States
Medcenter One Health System
Bismarck North Dakota, 58501, United States
Mid Dakota Clinic, P.C.
Bismarck North Dakota, 58501, United States
St. Alexius Medical Center
Bismarck North Dakota, 58501, United States
Altru Cancer Center at Altru Hospital
Grand Forks North Dakota, 58201, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa Oklahoma, 74136, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Geisinger Medical Group
State College Pennsylvania, 16801, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson South Carolina, 29621, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29304, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57104, United States
Avera McKennan Hospital and University Health Center
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center
Sioux Falls South Dakota, 57105, United States
Pasqua Hospital
Regina Saskatchewan, S4T 1, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina Saskatchewan, S4T 7, Canada

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

71

Study ID:

NCT00043069

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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