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.
Patients with localized prostate cancer were followed to progression or maximum 24 weeks after a single injection in one lobe of 2-8 mL ready-made paste (corresponding to 400-1600 mg 2-Hydroxyflutamid). Progression was defined as an increase in PSA by \> 25% over baseline or on-treatment nadir.Among the 24 patients the primary endpoint, plasma PSA nadir, was reached by 20 patients (Responders). Efficacy was measured primarily as PSA nadir, and secondly as time to PSA nadir and prostate volume change. Safety was monitored throughout the whole study period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
Tampere University Hospital
Tampere, Finland
Tampere University Hospital
Tampere, Finland
Proportion of Patients Showing PSA Nadir
Plasma PSA nadir is the lowest PSA reading achieved after any treatment for prostate cancer. The patients were observed once every 4th week during the study period.
Time frame: Measured every 4th week until progression or maximum 6 months.
Number of Patients Reporting Adverse Events Caused by the Study Treatment
* Adverse events caused by the study treatment * Abnormal, clinically relevant, laboratory parameters * Voiding symptoms * Vital Signs * Quality of Life
Time frame: Measured every 4th week till progression or maximum 6 months
Percent Change in Prostate Volume From Baseline to Nadir.
Prostate volume was measured at each visit to capture nadir and compared to baseline for all patients. Decrease in prostate volume is reported as percent change from baseline.
Time frame: Measured every 4th week until progression or maximum 6 months.
Time to PSA Nadir
Time frame was from baseline to day of PSA nadir.
Time frame: Measured every 4th week until progression or maximum 6 moths.
Percent Change in Prostate Volume From Baseline to Final Visit
Prostate volume was captured at each visit and percent change from baseline to final visit was measured. Final visit was either day of progression or after 6 months. Prostate volume decrease is reported in percent change from baseline
Time frame: Measured every 4th week until progresion or maximum 6 months.
Number of Days to Prostate Volume Nadir.
Number of Days from day of injection to prostate volume nadir.
Time frame: Measured every 4th week until progression or maximum 6 months.
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