Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.
Radical prostatectomy is used to treat early prostate cancer in otherwise well men, but is followed by later cancer relapse in 1 in 4 cases. This study aims to see if post-operative adjuvant therapy with a combination of zoledronic acid and docetaxel might help reduce relapse in such cases. Patients will be randomized to receive the adjuvant combination therapy or no therapy. All patients will be monitored closely for signs of relapse and treated appropriately with conventional salvage therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase IIb Randomised Clinical Trial of the Tolerability, Safety and Efficacy of Adjuvant Docetaxel-Zoledronic Acid After Prostatectomy for High-risk Early Prostate Cancer (AD-ZAP).|
- safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa [ Time Frame: 6 months after study entry ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
|Experimental: Zoledronic Acid||Drug: Zoledronic Acid|
|Active Comparator: Docetaxel||Drug: Docetaxel|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258765
|Novartis Investigative Site|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|