Status:
COMPLETED
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 ...
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 And...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00776594
Start Date
October 1 2008
End Date
September 1 2016
Last Update
October 21 2016
Active Locations (8)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
2
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201