NCTN: 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 (CALGB-90202)
Study ID: CALGB-90202
NCT Number: NCT00079001
Alliance for Clinical Trials in Oncology
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: 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 (CALGB-90202)
Trial Description:
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.
Clinical data presented in the following publication(s):
- PMID 24590644
- Additional unpublished data from CALGB-90202
Disease type(s): Reproductive System Neoplasm, Male - Prostate Cancer
Clinical dataset(s) included:
- NCT00079001-D1 (PMID 24590644): NCT00079001-D1 is one of 3 datasets that contain the data published in the analyses of PubMed ID 24590644 (-D1 through -D3). This dataset contains baseline characteristics, stratification factors, prior therapy, and metastatic site data.
- NCT00079001-D2 (PMID 24590644): NCT00079001-D2 is one of 3 datasets that contain the data published in the analyses of PubMed ID 24590644 (-D1 through -D3). This dataset contains primary analysis (time to skeletal-related event), time-to-event analysis, and treatment discontinuation data.
- NCT00079001-D3 (PMID 24590644): NCT00079001-D3 is one of 3 datasets that contain the data published in the analyses of PubMed ID 24590644 (-D1 through -D3). This dataset contains the toxicity data reported.
- NCT00079001-D4 (Unpublished data): Dataset NCT00079001-D4 contains data collected on Alliance trial CALGB-90202 which are not published in the primary publication for the trial. NCT00079001-D4 includes data on type of progression, time to progression, cause of death and clinical follow-up data.
You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Double-Blind
- Archive: The database of Genotypes and Phenotypes (dbGaP)