Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
The purpose of this study is to determine the acute and late toxicities from radiation therapy in combination with bevacizumab (given every 2 weeks for 16 weeks then every 3 weeks for 12 weeks), bicalutamide (every day for 16 weeks) and goserelin (every 3 months for 2 years).
Key facts
- Study ID
- NCT00349557
- Run by
- Benaroya Research Institute
- People needed
- 18
- Starts
- 2006-04-01
- Last updated by the study team
- 2014-07-16
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- High Risk Prostate Cancer as defined as ONE of the following:
- Clinical T2b-T4
- Gleason sum score 8-10
- PSA more than 20 and Gleason sum score 7
- In addition, clinical T2a patients are eligible if 5 or more biopsies contain Gleason 4+3 cancer (minimum of 10 biopsies total required)
- No evidence of metastatic disease within 60 days of enrollment, confirmed by physical examination, chest x-ray, bone scan, and computed tomography of the abdomen and pelvis
- ECOG performance status of 0, 1 or 2
You may not qualify if…
- Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer; any major surgery within four weeks, prior hormonal therapy (except finasteride for obstructive voiding symptoms)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study; Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- Presence of central nervous system or brain metastases
- Blood pressure of >150/100 mmHg
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- 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
- Virginia Mason Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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