Official Title: “Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer”

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).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Although there is no data on the toxicity with concurrent bevacizumab and hormonal therapy, the combination is not expected to increase toxicity seen when given as a single agent.

Abnormal tumor microenvironments, tumor progression, and metastatic spread are major factors contributing to treatment failures in radiotherapy. Anti-VEGF agents (e.g. bevacizumab) can help overcome these factors through several different mechanisims.

Studies also demonstrate prolonged use of anti-VEGF agents with radiation therapy was more effective at preventing metastases from irradiated tumors compared to a short course.

Patients generally start hormonal therapy and daily radiotherapy at the same time. This study will delay the start of radiotherapy until 8 weeks after the start of hormonal therapy and bevacizumab.

Intervention(s) in this Clinical Trial

• Drug: bevacizumab, bicalutamide and goserelin
• Procedure: intensity modulated radiation therapy (IMRT)

Primary Measures

• To determine the acute (within 90 days from 1st day of radiation therapy) toxicities from intensity modulated radiation therapy (IMRT) in conjunction with bevacizumab, bicalutamide, and goserelin.

Secondary Measures

• To evaluate the late toxicities (>90 days from 1st day of radiation therapy) of IMRT, bevacizumab, bicalutamide, and goserelin. Patients will be followed on study for toxicity evaluation for at least one year from day 1 if radiation therapy.
• To determine the tolerability of the combination of bevacizumab and hormonal therapy.

Inclusion Criteria:

• High Risk Prostate Cancer as defined as ONE of the following:
• 1. Clinical T2b-T4
• 2. Gleason sum score 8-10
• 3. PSA more than 20 and Gleason sum score 7
• 4. 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

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Benaroya Research Institute

Overall Clinical Trial Officials and Contacts

Jacqueline Vuky, MD Principal Investigator Virginia Mason Medical Center  

Overall Contact: Sarah Warren, CRC 206-223-7507 sarah.warren@vmmc.org

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00349557

Study ID Number: BRI 3031500

ClinicalTrials.gov Identifier: NCT00349557

Health Authority: United States: Food and Drug Administration

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