Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in
terms of reducing the size of the prostate volume in prostate cancer patients who were
scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to
receiving radiotherapy, it is recommended that patients with intermediate to high risk
prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is
known to reduce the size of the prostate and thereby decrease the required radiation field
and enable a more safe and effective treatment. In this trial, participants were randomly
selected (like flipping a coin) to receive either degarelix given alone or a standard hormone
therapy (combination of goserelin and bicalutamide. The treatment was given for three months
and the prostate size was measured by ultra sound at the beginning and at the end of the
trial. The participants were required to come to the clinic for 5 or 6 visits during the
three months.