CALGB 90202 - 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
Description
The primary objective of this study is to determine whether treatment with Zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event.
IRB Number
SC-05-039
Study/Treatment
Prostate Cancer
Inclusion/Notes
Patients must have histologically documentation of prostate adenocarcinoma.
Patients must have at least one bone metastasis by radiographic imaging.
Patients must receive androgen deprivation therapy (ADT) for treatment of prostate cancer.
Hormone therapy at any point prior to 6 months before enrollment is prohibited.
Prior neoadjuvant and/or adjuvant hormone therapy is allowed provided that the duration of hormone therapy was six months or less and the hormone therapy was discontinued more than six months prior to study entry.
No prior treatment with a bisphosphonate.
No prior treatment with radiopharmaceuticals.
There must be => 4 weeks since completion of prior radiation therapy
ECOG performance status of 0-2.
Age 18 years or older.
Contact Name
Nancy N. and J.C. Lewis Cancer & Research Pavilion
Phone
(912) 819-5704
Nancy N. and J.C. Lewis Cancer & Research Pavilion225 Candler Drive, Savannah, Georgia 31405
