Conditions: Prostate Cancer
Keywords: Androgen deprivation therapy ADT bevacizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 102
Healthy volunteers: no

Brief summary:
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).

Detailed description:
* 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.

Arms:
arm 1: Androgen Deprivation Therapy Plus Bevacizumab arm 2: Androgen Deprivation Therapy Alone

Interventions: intervention 1: Androgen Deprivation Therapy intervention 2: bicalutamide intervention 3: bevacizumab
Intervention descriptions: intervention 1: 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 intervention 2: 50mg orally daily for 6 months intervention 3: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Protocol document: