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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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).

Key facts

Study ID

NCT00776594

Run by

Dana-Farber Cancer Institute

People needed

102

Starts

2008-10-01

Expected to finish

2016-09-01

Last updated by the study team

2016-10-21

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — 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

Full record on ClinicalTrials.gov

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