Prostate Cancer Clinical Trial

Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation

Summary

RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss.

PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.

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Full Description

OBJECTIVES:

Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate.
Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens.
Compare markers of bone formation and resorption in patients treated with these regimens.
Compare the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) in patients treated with these regimens.
Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens.
Compare the survival rate of patients treated with these regimens.

OUTLINE: Patients are stratified according to race (black vs other). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
Arm II: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed prostate cancer

Stage III or IV disease

Received at least 3 months of prior androgen deprivation therapy (no maximum amount/time) by either surgical or medical castration

Medical castration may be by intermittent or continuous androgen suppression via single- or combined-drug androgen blockade
Continued concurrent androgen deprivation therapy required throughout study participation
No bone metastases by baseline bone scan

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 1 year

Hematopoietic

Not specified

Hepatic

Bilirubin less than 3 times upper limit of normal (ULN)
AST and ALT less than 3 times ULN
No chronic liver disease

Renal

Creatinine no greater than 2.0 mg/dL

Other

Fertile patients must use effective contraception
No Paget's disease
No Cushing's disease
No hyperthyroidism
No hyperprolactinemia

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Prior chemotherapy for prostate cancer allowed

Endocrine therapy

See Disease Characteristics
More than 12 months since prior suppressive doses of thyroxine or calcitonin
More than 6 months since prior corticosteroids
Concurrent corticosteroids allowed (after enrollment on study)

Radiotherapy

Prior radiotherapy for prostate cancer allowed

Surgery

See Disease Characteristics

Other

More than 12 months since prior bisphosphonate therapy (oral or IV)

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

53

Study ID:

NCT00058188

Recruitment Status:

Terminated

Sponsor:

Northwestern University

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There are 2 Locations for this study

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Northwestern University
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
John H. Stroger Hospital of Cook County
Chicago Illinois, 60612, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

53

Study ID:

NCT00058188

Recruitment Status:

Terminated

Sponsor:


Northwestern University

How clear is this clinincal trial information?

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