GUMDROP : AOH - IMAAGEN A Multicenter, Open label, Single arm, Phase II study of Abiraterone Acetate plus Prednisone in subjects with Advanced Prostate Cancer without Radiographic Evidence of Metastatic Disease
Created by Marte, Jenn (NIH/NCI) [E], last modified by Dipak Dahal on Apr 24, 2012
Description: |
Open label, single arm study of Abiraterone Acetate Plus Prednisone in subjects with advance prostate cancer who have rising PSA and no evidence of metastatic disease defined by modified RECIST criteria.
- Must currently be receiving and have been receiving continuous treatment with GnRH monotherapy for at least 6 months before screening with a serum testosterone level of <50 ng/dL or have undergone an orchiectomy with a serum testosterone level of <50 ng/dL.
- Have rising PSA defined as a PSA of > 10 ng/mL obtained at screening or PSADT of <10 months with the first of the 3 consecutive PSA values used to calculate PSADT >2.0 ng/mL
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Link: |
http://clinicaltrials.gov/ct2/show/NCT01314118 |
Site: |
Associates in Oncology/Hematology; P.C. (AOH) - Rockville, MD
Tel: 301 424 6231 |
Principal Investigator: |
Paul M. Thambi, MD |