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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


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Osteoporosis, Prostate Cancer

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Bone density change as measured by dual-energy x-ray absorptiometry from baseline to 13 months

Outcome Description:

To assess bone density change as measured by dual-energy x-ray absorptiometry

Outcome Time Frame:

Bone scan taken at baseline and month 13

Safety Issue:

No

Principal Investigator

Charles L. Bennett, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 02U1

NCT ID:

NCT00058188

Start Date:

March 2003

Completion Date:

December 2015

Related Keywords:

  • Osteoporosis
  • Prostate Cancer
  • osteoporosis
  • stage III prostate cancer
  • stage IV prostate cancer
  • Osteoporosis
  • Prostatic Neoplasms

Name

Location

Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Northwestern UniversityChicago, Illinois  60611
John H. Stroger Hospital of Cook CountyChicago, Illinois  60612