Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists: A Prospective, Observational, Phase IV Study (DELAY)
This trial will include hormone sensitive prostate cancer patients switched to Degarelix
therapy after failing on GnRH agonists but prior to use of secondary hormonal treatments
such as antiandrogens. The purpose of this trial is to determine the effect of Degarelix's
direct mode of action on androgen levels and whether continuous use of Degarelix improves
This is an open-label, multi-centre, Phase IV observational trial with s.c. injections of
Degarelix one-month depot in patients with advanced prostate cancer.
The visit frequency is once a month (28-day intervals), with eCRF data entry at every 4
months. All patients will be treated with a one-month starting dose followed by 23 monthly
maintenance doses for a duration of 672 days. The primary endpoints will be evaluated after
24 treatment months.
In total, 25 visits are scheduled for all patients.
Observational Model: Case-Only, Time Perspective: Prospective
To evaluate testosterone supression in hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists
Two Years after first dose of degarelix.
Richard Casey, M.D.
CMX Research Inc
Canada: Health Canada