Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed 18 and over NCI NU-02U1 NCT00058188

Objectives

1. 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.
2. Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens.
3. Compare markers of bone formation and resorption in patients treated with these regimens.
4. 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.
5. Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens.
6. Compare the survival rate of patients treated with these regimens.

Entry 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

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)

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

Expected Enrollment

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

Outcomes

Bone density change as measured by dual-energy x-ray absorptiometry from baseline to13 months

Percentage change in lumbar spine and hip bone density as measured by plain film x-rays of lumbar spine and pelvis from baseline to 13 months
Markers of bone formation and resorption
Incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone)
Incidence of new or progressive bone metastatic disease
Survival rate

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Charles Bennett, MD, PhD, Protocol chair		Ph: 312-503-0804 Email: cbenne@northwestern.edu

Registry Information
Official Title		A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men with Prostate Cancer Receiving Long-Term Androgen Deprivation
Trial Start Date		2003-01-06
Trial Completion Date		2010-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00058188
Date Submitted to PDQ		2003-02-21
Information Last Verified		2009-01-07
NCI Grant/Contract Number		CA60553

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