The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
50mg orally daily for 6 months
15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
Johns Hopkins University
Baltimore, Maryland, United States
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Relapse-free Survival
To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
Time frame: 2 years
Number of Participants With PSA <0.2 ng/ml at Six Months
Number of participants with a PSA \<0.2 ng/ml at six months (upon completion of treatment).
Time frame: Six months (at completion of treatment)
Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).
The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.
Time frame: 6 months
Analysis of Cytokines and Angiogenic Factors in Plasma/Serum
Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).
Time frame: 6 months
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Detroit, Michigan, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
The University of Texas M D Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States