At a glance
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An Open, Single and Multiple Dose, Efficacy and Safety Proof of Principle Study of Liproca Depot, a Controlled Release Formulation of 2-hydroxyflutamide, Injected Into the Prostate in Patients With Localized Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating 2-hydroxyflutamide (2-HOF) [Liproca Depot] and 2-Hydroxyflutamide for Prostate Cancer. Completed, enrolled 24 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Ready made paste including 600 mg 2-HOF for injection as a single dose
The Product consists of two sterile components, one aqueous liquid and a dry powder, containing the active drug 2-Hydroxyflutamide (2-HOF. The two components were mixed under aceptic conditions to a paste prior to administration.