Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
- Participants will be randomized into one of two study groups. The first group will
receive Androgen Deprivation Therapy (ADT) plus bevacizumab. The second group will
receive ADT alone.
- For the Androgen Deprivation therapy either (treating physician discretion)leuprolide
or goserelin acetate (given as injections) every 3 months for a total of 6 months.
Bicalutamide will also be taken orally daily for a total of 6 months.
- Bevacizumab will be given intravenously every three weeks for a total of 8 infusions
over 6 months.
- Participants will be evaluated every 7-9 weeks with vitals, physical exam, PS,
laboratories including PSA and testosterone.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
2 years
No
Mary-Ellen Taplin, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Institutional Review Board
08-190
NCT00776594
October 2008
December 2013
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
The University of Texas M D Anderson Cancer Center | Houston, Texas 77030 |
Beth-Israel Deaconess Medical Center | Boston, Massachusetts |
University of Wisconsin Carbone Cancer Center | Madison, Wisconsin 53792-5669 |