Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer

What Was Tested

The trial (phase 2) is built around Goserelin.

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).

The registry classes the interventions as drug and procedure.

More on the Plan

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.

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.

Who Took Part

18 planned participants were the target.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: High Risk Prostate Cancer as defined as ONE of the following:. 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.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: presence of central nervous system or brain metastases; blood pressure of \>150/100 mmhg; history of myocardial infarction within 6 months.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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.

It also tracked 2 secondary outcomes, for example To determine the tolerability of the combination of bevacizumab and hormonal therapy.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Goserelin in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.