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Prostate Cancer

Zoledronate For Prostate Cancer and Bone Metastases (CTSU C90202)
A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone
Status Conditions Phase Study ID
Recruiting Metastatic Cancer
Prostate Cancer		 Phase III CTSU C90202
NCT00079001
Summary

RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.

PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.


Investigator
Fred Appelbaum, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • No small cell, neuroendocrine, or transitional cell carcinomas

  • At least 1 bone metastasis by bone scan, MRI, CT scan, or plain radiographs

    • Indeterminate lesions should be confirmed by a second imaging method
    • At least 1 bone metastasis with no prior irradiation

  • Concurrent androgen deprivation therapy required, defined as any of the following:

    • Bilateral orchiectomy
    • Gonadotropin-releasing hormone (GnRH) agonist with or without an antiandrogen
Last Updated
June 03, 2010
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.