Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

Phase 2

Completed

Interventions: Drug: Androgen Deprivation Therapy
Drug: bicalutamide
Drug: bevacizumab

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.

Recruitment & Eligibility

Inclusion Criteria

History of biopsy documented prostate cancer (any Gleason score)
Past treatment with prostatectomy with or without salvage prostate/pelvic radiation or primary radiation (external beam or brachytherapy)
If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
PSA recurrence with PSAdt < 18 months. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be greater than 2.0 ng/ml
No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis or CXR
Prior ADT allowed if < 6 months and testosterone recovered to within 50 units (ng/dl) of normal range
ECOG Performance status of 0-1
Absolute neutrophil count of >1,500
Platelet count > 100,000
Hg > 8g/dl
No history of bleeding or thromboses within the last 12 months that required medical intervention

Exclusion Criteria

History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
Medical condition requiring concomitant corticosteroids
Active infection
Prior chemotherapy allowed if was < 6 cycles and > 6 months prior to study entry
Documented local recurrence or metastatic prostate cancer
Inability to comply with study and/or follow-up procedures
Life expectancy of less than 2 years
Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study

Arm && Interventions

Group	Intervention	Description
Group 1	bicalutamide	Androgen Deprivation Therapy Plus Bevacizumab
Group 1	bevacizumab	Androgen Deprivation Therapy Plus Bevacizumab
Group 1	Androgen Deprivation Therapy	Androgen Deprivation Therapy Plus Bevacizumab
Group 2	Androgen Deprivation Therapy	Androgen Deprivation Therapy Alone
Group 2	bicalutamide	Androgen Deprivation Therapy Alone

Primary Outcome Measures

Name	Time	Method
Relapse-free Survival	2 years	To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With PSA <0.2 ng/ml at Six Months	Six months (at completion of treatment)	Number of participants with a PSA \<0.2 ng/ml at six months (upon completion of treatment).
Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).	6 months	The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.
Analysis of Cytokines and Angiogenic Factors in Plasma/Serum	6 months	Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).

Locations (8): Cancer Institute of New Jersey
🇺🇸
New Brunswick, New Jersey, United States
Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸
New York, New York, United States
University of Wisconsin Carbone Cancer Center
🇺🇸
Madison, Wisconsin, United States
Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
Beth-Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
The University of Texas M D Anderson Cancer Center
🇺🇸
Houston, Texas, United States
Karmanos Cancer Institute
🇺🇸
Detroit, Michigan, United States