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.
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.
Mary-Ellen Taplin, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|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|