Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer

Benaroya Research Institute

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: bevacizumab, bicalutamide and goserelin

Procedure: intensity modulated radiation therapy (IMRT)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00349557

BRI 3031500

Details and patient eligibility

About

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).

Full description

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.

Enrollment

18 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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