An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
The primary objective was to evaluate efficacy of a single dose of Liproca Depot in patients
with localized prostate cancer. Primary efficacy variable was the proportion of patients
showing PSA nadir. 24 Caucasian men, with a mean age at inclusion of 68.4 years, with
localized prostate cancer were injected once with a ready made paste including 600 mg
2-hydroxyflutamide (Liproca Depot) into the site of the prostate where the tumour was
localized. The patient was monitored for prostate-specific antigen (PSA) for maximum 6 months
or to progression within this time period. The primary endpoint showed interesting results
with high success rate (83%), i.e. proportion of patients (Responders) that reached plasma
PSA nadir.